Page last updated: 2024-11-07

gadolinium 1,4,7,10-tetraazacyclododecane-n,n',n'',n'''-tetraacetate

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Description

gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate: RN refers to Na salt [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID122152
MeSH IDM0144923

Synonyms (13)

Synonym
gd-dota
92923-44-9
99j2xuf1jt ,
gadoterate sodium
gadolinium 1,4,7,10-tetraazacyclododecane-n,n',n'',n'''-tetraacetate
gadolinate(1-), (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetato(4-)-.kappa.n1,.kappa.n4,.kappa.n7,.kappa.n10,.kappa.o1,.kappa.o4,.kappa.o7,.kappa.o10)-, sodium (1:1)
gadoterate sodium [who-dd]
gadolinium sodium 2,2',2'',2'''-(1,4,7,10-tetraazacyclododecane-1,4,7,10-tetrayl)tetraacetate (1/1/1)
DTXSID10918889
sodium;gadolinium(3+);2-[4,7,10-tris(carboxylatomethyl)-1,4,7,10-tetrazacyclododec-1-yl]acetate
Q27272217
[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetato(4-)-kappan1,kappan4,kappan7,kappan10,kappao1,kappao4,kappao7,kappao10]-gadolin
gadolinium(iii) sodium 2,2',2'',2'''-(1,4,7,10-tetraazacyclododecane-1,4,7,10-tetrayl)tetraacetate

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" Adverse events were found with a similar frequency in the two groups (17."( Randomised double blind trial of the safety and efficacy of two gadolinium complexes (Gd-DTPA and Gd-DOTA).
Berry, I; Brugières, P; de Schepper, AM; Degryse, HR; Gaston, A; Le Bras, F; Manelfe, C; Marsault, C; Parizel, PM; Wichmann, W, 1994
)
0.29
" In conclusion, MRI measurements may bring multiparametric information upon the efficiency and tissue toxicity of an ET protocol by using a simple and safe CA."( In vivo NMR imaging evaluation of efficiency and toxicity of gene electrotransfer in rat muscle.
Bureau, MF; Carlier, PG; Leroy-Willig, A; Scherman, D, 2005
)
0.33
" Overall, CPMV appears to be a safe and non-toxic platform for in vivo biomedical applications."( Bio-distribution, toxicity and pathology of cowpea mosaic virus nanoparticles in vivo.
Destito, G; Finn, MG; Manchester, M; Osborn, K; Prasuhn, D; Rae, CS; Singh, P; Yeh, RM, 2007
)
0.34
"Meglumine gadoterate did not affect renal function and was a safe contrast agent in patients with CKD."( Safety of meglumine gadoterate (Gd-DOTA)-enhanced MRI compared to unenhanced MRI in patients with chronic kidney disease (RESCUE study).
Alison, D; Bacigalupo, L; Billiouw, JM; Boffa, JJ; Campioni, P; Deray, G; Devos, D; Ferreiros, J; Glowacki, F; Hannedouche, T; Maes, B; Marti-Bonmati, L; Rigothier, C; Rouviere, O; Vrtovsnik, F, 2013
)
0.39
" In conclusion, the toxic effects of our nanoprobes may mainly result from the aggregation of particles in phagosomes."( In vivo immunotoxicity of SiO2@(Y0.5Gd0.45Eu0.05)2O3 as dual-modality nanoprobes.
Chen, X; He, F; Li, E; Peng, Y; Tian, X; Yang, F; Zhu, J, 2014
)
0.4
" Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid."( Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies.
Balassy, C; Miller, SF; Roberts, D, 2015
)
0.42

Pharmacokinetics

ExcerptReferenceRelevance
" Regardless of age-related differences in the pharmacokinetic parameters, a diabetic state induced several alterations in the Gd-DOTA pharmacokinetic parameters."( Pharmacokinetic study of gadolinium-DOTA in control and streptozocin diabetic rats.
Bonnet, PA; Chambon, C; Doucet, D; Fernandez, JP; Michel, A, 1992
)
0.28
" Its behavior was found to be similar to that of urographic and angiographic iodinated contrast media with a plasma elimination half-life of 91 +/- 14 minutes (mean +/- standard deviation [SD]), a small distribution volume of 171."( Gd-DOTA. Pharmacokinetics and tolerability after intravenous injection into healthy volunteers.
Bonnemain, B; Chambon, C; Davies, R; Le Mignon, MM; Warrington, S, 1990
)
0.28
" The pharmacokinetic characteristics and the very low toxicity of Gd-DOTA Mgl may prove its suitability for intravenous or oral administration in humans."( Experimental study of DOTA-gadolinium. Pharmacokinetics and pharmacologic properties.
Allard, M; Bonnemain, B; Caillé, JM; Doucet, D; Kien, P, 1988
)
0.27
"In this paper we discuss novel MR imaging blood pool agents characterized by new pharmacokinetic properties."( P760 and P775: MRI contrast agents characterized by new pharmacokinetic properties.
Benderbous, S; Bonnemain, B; Bourrinet, P; Corot, C; Dencausse, A; Devoldere, L; Meyer, D; Port, M; Rousseaux, O; Schaefer, M; Simonot, C, 1999
)
0.3
"Three main classes of blood pool agents have been defined and characterized according to their pharmacokinetic properties: low diffusion agents, rapid clearance blood pool agents, slow clearance blood pool agents."( P760 and P775: MRI contrast agents characterized by new pharmacokinetic properties.
Benderbous, S; Bonnemain, B; Bourrinet, P; Corot, C; Dencausse, A; Devoldere, L; Meyer, D; Port, M; Rousseaux, O; Schaefer, M; Simonot, C, 1999
)
0.3
"The plasma pharmacokinetic profiles were similar for Gd-DOTA and P760 (t1/2=13."( Comparison of plasma and peritoneal concentrations of various categories of MRI blood pool agents in a murine experimental pharmacokinetic model.
Bourasset, F; Bourrinet, P; Corot, C; Dencausse, A; Ducret, M, 2001
)
0.31
" As a result of this high molecular volume, P792 presents an unusual pharmacokinetic profile, as it is a Rapid Clearance Blood Pool Agent (RCBPA) characterized by limited diffusion across the normal endothelium."( P792: a rapid clearance blood pool agent for magnetic resonance imaging: preliminary results.
Corot, C; Dencausse, A; Devoldere, L; Idée, JM; Le Greneur, S; Meyer, D; Port, M; Raynal, I; Rousseaux, O; Simonot, C, 2001
)
0.31
"Due to its physicochemical and pharmacokinetic properties, P792 allows the use of a reduced dosage of gadolinium, resulting in less T2* effect without compromising T1 enhancement."( Renal functional contrast-enhanced magnetic resonance imaging: evaluation of a new rapid-clearance blood pool agent (p792) in sprague-dawley rats.
Claudon, M; Corot, C; Felblinger, J; Grenier, N; Mandry, D; Odille, F; Pedersen, M; Robert, P, 2005
)
0.33
" This study demonstrates the potential of DCE-MRI and pharmacokinetic modeling to study early changes in inflammatory activity in rheumatoid arthritis following treatment."( Pharmacokinetic modeling of dynamic contrast-enhanced MRI of the hand and wrist in rheumatoid arthritis and the response to anti-tumor necrosis factor-alpha therapy.
Barnes, T; Campbell, RS; Connolly, S; Eyes, B; Hodgson, RJ; Moots, R, 2007
)
0.34
" Tofts model is one of the most frequently used pharmacokinetic models in analyzing perfusion process."( Relationship between marrow perfusion and bone mineral density: a pharmacokinetic study of DCE-MRI.
Griffith, JF; Leung, PC; Lv, H; Ma, HT; Yeung, DK; Zhao, X, 2012
)
0.38
" Pharmacokinetic models were implemented on the absolute concentration calculated from the MRI signal enhancement measurements."( Quantitative biodistribution and pharmacokinetics of multimodal gadolinium-based nanoparticles for lungs using ultrashort TE MRI.
Bianchi, A; Coll, JL; Courtois, A; Crémillieux, Y; Dufort, S; Lux, F; Tillement, O, 2014
)
0.4
" The blood clearance curve was biphasic, with a distribution half-life of less than 3 min and an elimination half-life of ∼21."( 64Cu-DOTA as a surrogate positron analog of Gd-DOTA for cardiac fibrosis detection with PET: pharmacokinetic study in a rat model of chronic MI.
Bluemke, DA; Davies-Venn, C; Kim, H; Kim, I; Kim, JS; Lee, SJ; Paik, CH; Yang, BY; Yao, Z, 2016
)
0.43
"Dynamic-contrast enhanced magnetic resonance imaging (DCE-MRI) is used for detailed characterization of pathology of lesions sites, such as brain tumors, by quantitative analysis of tracer's data through the use of pharmacokinetic (PK) models."( Assessment of DCE-MRI parameters for brain tumors through implementation of physiologically-based pharmacokinetic model approaches for Gd-DOTA.
Kontopodis, E; Marias, K; Sakkalis, V; Spanakis, M; Van Cauter, S, 2016
)
0.43
"To differentiate benign from malignant orbital masses using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) based on tumor flow residence time τ calculated with the aid of a pharmacokinetic tumor model."( DCE-MR imaging of orbital lesions: diagnostic performance of the tumor flow residence time τ calculated by a multi-compartmental pharmacokinetic tumor model based on individual factors.
Asbach, P; Bertelmann, E; Denecke, T; Erb-Eigner, K; Haas, M; Hamm, B; Lawaczeck, R; Pietsch, H; Ro, SR; Schwenke, C; Taupitz, M, 2019
)
0.51
" There are currently no CAs on the market with appropriate pharmacokinetic (PK) parameters, namely long persistence in the blood, that can be easily used for MRA."( Pharmacokinetics and biodistribution study of self-assembled Gd-micelles demonstrating blood-pool contrast enhancement for MRI.
Allémann, E; Babič, A; Crowe, LA; Helm, L; Lenglet, S; Thomas, A; Vallée, JP; Van De Looij, Y; Vorobiev, V, 2019
)
0.51

Bioavailability

ExcerptReferenceRelevance
" Tuftsin receptor-specific biological-function domain may have a modified in vivo biodistribution profile, bioavailability and pharmacokinetics subsequent to its conjugation to a metal ion-binding backbone."( Tuftsin derivatives of FITC, Tb-DOTA or Gd-DOTA as potential macrophage-specific imaging biomarkers.
Allan, SM; Faulkner, S; Feng, J; Kauppinen, R; Meloni, MM; Narvainen, J; Vidyasagar, R,
)
0.13

Dosage Studied

ExcerptRelevanceReference
" Serum calcium was dosed in duplicate by conventional colorimetric techniques involving o-cresol-phthalein complexone (OCP) or methylthymol blue (MTB) as reagents."( Interference of magnetic resonance imaging contrast agents with the serum calcium measurement technique using colorimetric reagents.
Berthommier, C; Corot, C; Devoldere, L; Diai, A; Idee, JM; Lin, J; Port, M; Raynal, I; Robert, M, 1999
)
0.3
"3) or half dosage (65."( Renal functional contrast-enhanced magnetic resonance imaging: evaluation of a new rapid-clearance blood pool agent (p792) in sprague-dawley rats.
Claudon, M; Corot, C; Felblinger, J; Grenier, N; Mandry, D; Odille, F; Pedersen, M; Robert, P, 2005
)
0.33
"Due to its physicochemical and pharmacokinetic properties, P792 allows the use of a reduced dosage of gadolinium, resulting in less T2* effect without compromising T1 enhancement."( Renal functional contrast-enhanced magnetic resonance imaging: evaluation of a new rapid-clearance blood pool agent (p792) in sprague-dawley rats.
Claudon, M; Corot, C; Felblinger, J; Grenier, N; Mandry, D; Odille, F; Pedersen, M; Robert, P, 2005
)
0.33
" Growth curves supported the dose-response observations."( Effect of different classes of gadolinium-based contrast agents on control and nephrogenic systemic fibrosis-derived fibroblast proliferation.
Burden, AD; Edward, M; Jardine, AG; Newton, BB; Quinn, JA, 2010
)
0.36
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (581)

TimeframeStudies, This Drug (%)All Drugs %
pre-199021 (3.61)18.7374
1990's140 (24.10)18.2507
2000's147 (25.30)29.6817
2010's239 (41.14)24.3611
2020's34 (5.85)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 8.78

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be weak demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index8.78 (24.57)
Research Supply Index6.51 (2.92)
Research Growth Index5.28 (4.65)
Search Engine Demand Index0.00 (26.88)
Search Engine Supply Index0.00 (0.95)

This Compound (8.78)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials31 (4.86%)5.53%
Reviews21 (3.29%)6.00%
Case Studies33 (5.17%)4.05%
Observational1 (0.16%)0.25%
Other552 (86.52%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (34)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
LowEr Administered Dose With highEr Relaxivity: Gadovist vs Dotarem (LEADER 75) [NCT03602339]Phase 4157 participants (Actual)Interventional2018-11-14Completed
Contrast Enhanced Breast MRI: Comparison of Two Macrocyclic Gadolinium-Based Contrast Agents: Gadoterate Meglumine (Dotarem) and Gadobutrol (Gadavist). A Prospective Study. [NCT03730051]Phase 4258 participants (Anticipated)Interventional2021-03-01Recruiting
Evaluation of Gadoterate in Patients With Renal Dysfunction [NCT02382380]Phase 446 participants (Actual)Interventional2015-03-31Active, not recruiting
A Pilot Study to Evaluate Molecular Imaging Methods in Primary Sjögren's Syndrome [NCT02899377]25 participants (Actual)Interventional2016-11-18Completed
Diffusion MRI in Heart Failure [NCT02973633]Early Phase 1160 participants (Anticipated)Interventional2017-06-30Recruiting
Development of Activity MRI (aMRI): Direct Comparison to PET in Human Subjects [NCT05937776]20 participants (Anticipated)Observational2023-12-11Not yet recruiting
Intra-individual Open-label, Single Center Study to Compare Unenhanced MRI With Dotarem Enhanced MRI in Pediatric and Neonatal Patient Population (<18years) [NCT03023566]250 participants (Actual)Observational2017-02-09Completed
Efficacy Evaluation of Dotarem®-Enhanced MRA Compared to Gadovist®-Enhanced MRA in the Diagnosis of Clinically Significant Abdominal or Limb Arterial Diseases [NCT01026389]Phase 4189 participants (Actual)Interventional2009-10-31Completed
Abbreviated MRI Protocol: Initial Experience With Dotarem® (Gadoterate Meglumine) [NCT04341129]Early Phase 150 participants (Actual)Interventional2020-07-13Completed
Renal Safety Evaluation After Dotarem®-Enhanced MRI Compared With Non-enhanced MRI in Patients at High Risk of Developing Contrast Medium Induced Nephropathy [NCT00650845]Phase 4135 participants (Actual)Interventional2008-01-31Completed
Assessment of Immediate Adverse Reactions in Children Under 2 Years of Age Following Administration of Gadoteric Acid (Gd-DOTA or Dotarem) [NCT02609919]150 participants (Actual)Observational2016-01-31Completed
Prospective Evaluation of Potential Effects of Repeated Gadolinium-based Contrast Agent (GBCA) Administrations of the Same GBCA on Motor and Cognitive Functions in Neurologically Normal Adults in Comparison to a Non-GBCA Exposed Control Group [NCT04373564]Phase 42,076 participants (Anticipated)Interventional2021-03-24Recruiting
[NCT02593370]Phase 126 participants (Actual)Interventional2015-10-31Completed
Shamrock - Ultrasound/MR Image Fusion Guided Lumbar Plexus Block [NCT02718976]Phase 222 participants (Actual)Interventional2016-03-31Completed
A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of Any Body Region (Except CNS), Compared [NCT05915728]Phase 3390 participants (Anticipated)Interventional2023-07-24Recruiting
A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of the Central Nervous System (CNS), Compa [NCT05915702]Phase 3295 participants (Anticipated)Interventional2023-07-24Recruiting
Evaluation of Efficacy and Safety of Dotarem in Magnetic Resonance Mammography [NCT03041298]1,537 participants (Actual)Observational2011-09-30Completed
Evaluation of Dotarem Safety [NCT03048006]44,456 participants (Actual)Observational2011-01-31Completed
Doxorubicin-associated Cardiac Tissue Remodeling Followed by CMR of Myocardial Extracellular Volume and Myocyte Size in Breast Cancer Patients [NCT03000036]27 participants (Actual)Interventional2012-07-31Completed
Evaluation of Dotarem-enhanced MRA Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Carotid and Vertebral Basilar Arterial Disease [NCT01012674]Phase 3211 participants (Actual)Interventional2009-10-31Completed
Assessment With Cardiac Computed Tomography Angiography (CCTA) and Magnetic Resonance Imaging (MRI) in Asymptomatic Patients With Type 2 Diabetes for Detection of Unrecognized Myocardial Scar in Subclinical Coronary Atherosclerosis [NCT01254552]Phase 4351 participants (Actual)Interventional2010-08-31Completed
Collagen-targeted PET Imaging for Early Interstitial Lung Disease [NCT05417776]Phase 230 participants (Anticipated)Interventional2022-09-28Recruiting
Safety and Dialysability of Dotarem® in Dialysed Patients - Phase 1 Clinical Study [NCT01449266]Phase 110 participants (Actual)Interventional2011-11-30Completed
Evaluation of Dotarem-enhanced Magnetic Resonance Angiography (MRA) Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Renal Arterial Disease [NCT00980681]Phase 313 participants (Actual)Interventional2009-09-30Terminated(stopped due to Lack of recruitment.)
Randomized, Blinded, Placebo-controlled Crossover Study Assessing Association Between Gadolinium-based Contrast Agent Administration and Transient Dyspnea/Arterial Phase Motion Artifact [NCT02431598]Phase 444 participants (Actual)Interventional2015-06-30Completed
Evaluation of Dotarem-enhanced Magnetic Resonance Angiography (MRA) Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Renal Arterial Disease [NCT00845702]Phase 333 participants (Actual)Interventional2009-04-30Terminated(stopped due to lack of recruitment.)
Evaluation of Regional Gadolinium Retention in the Brain Using QSM With Correlation to Regional DCE MRI Permeability Using GOCART Technique in Intracranial Neoplasm Patients Receiving Gadobenate Dimeglumine (MultiHance) or Gadoterate Meglumine (Dotarem) [NCT03091803]0 participants (Actual)Observational2017-04-04Withdrawn(stopped due to No accrual)
Efficacy of Dotarem® (Gd-DOTA) Versus Gadovist® (Gd-DO3A-butrol) for Late Gadolinium Enhancement Cardiac Magnetic Resonance and Relationship to Outcomes: A Pilot Study [NCT03057561]120 participants (Anticipated)Interventional2016-10-01Enrolling by invitation
Phase IV Study of DCE-MRI Using Dotarem® in Evaluation of Therapeutic Response to Sorafenib in Patients With Advanced Stage HCC [NCT01806740]Phase 437 participants (Actual)Interventional2013-05-09Terminated(stopped due to The planned number of enrolled patients was not reached.)
Gadolinium Retention in Human Bone Tissue in Pediatric Patients: A Comparison of Dotarem Versus MultiHance MRI Contrast Agents [NCT03337594]60 participants (Anticipated)Observational2017-10-01Recruiting
Performance of Elucirem® (Gadopiclenol) in Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) Perfusion of Brain Gliomas Phase IIIb Clinical Trial [NCT06057168]Phase 3138 participants (Anticipated)Interventional2023-09-07Recruiting
Evaluation of Dotarem-enhanced MRA Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Carotid and Vertebral Basilar Arterial Disease [NCT01010932]Phase 3222 participants (Actual)Interventional2009-10-31Completed
Safety and Efficacy Evaluation of DOTAREM® in Magnetic Resonance Imaging (MRI) in Patients With Central Nervous System (CNS) Lesions. [NCT01211873]Phase 3416 participants (Actual)Interventional2010-09-30Completed
DOTAREM® Pharmacokinetics, Safety and Efficacy Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive) [NCT02411201]Phase 451 participants (Actual)Interventional2015-03-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00650845 (6) [back to overview]eGFR Values Variation Between Baseline and 72±24 Hours After Examination, in the Per Protocol Population
NCT00650845 (6) [back to overview]Number of Patients Presenting Contrast-induced Nephropathy as Defined by an Increase in Serum Creatinine Levels of a Least 25% Over Baseline Levels, in the Full Analysis Set Population.
NCT00650845 (6) [back to overview]Number of Patients Presenting Contrast-induced Nephropathy as Defined by an Increase in Serum Creatinine Levels of at Least 25% Over Baseline Levels, in the Per Protocol Population.
NCT00650845 (6) [back to overview]Percent Change of Estimated Glomerular Filtration Rate (eGFR) Values From Baseline to 72±24 Hours After Examination, in the Full Analysis Set Population
NCT00650845 (6) [back to overview]Percent Change of Serum Creatinine Level From Baseline to 72±24 Hours After Examination, in the Full Analysis Set Population.
NCT00650845 (6) [back to overview]Percent Change of Serum Creatinine Level Variation From Baseline to 72±24 Hours After Examination, in the Per Protocol Population
NCT00980681 (1) [back to overview]Percent of Non Assessable Renal Artery Segments
NCT01010932 (3) [back to overview]Technical Failure Rate
NCT01010932 (3) [back to overview]Specificity
NCT01010932 (3) [back to overview]Sensitivity
NCT01012674 (3) [back to overview]Specificity
NCT01012674 (3) [back to overview]Sensitivity
NCT01012674 (3) [back to overview]Technical Failure Rate
NCT01026389 (4) [back to overview]Intra-patient Accuracy (Percent Agreement), On-site Data
NCT01026389 (4) [back to overview]Intra-patient Accuracy, in Off-site Readings
NCT01026389 (4) [back to overview]Sensitivity
NCT01026389 (4) [back to overview]Specificity
NCT01211873 (4) [back to overview]Number of Lesions
NCT01211873 (4) [back to overview]Image Quality Score
NCT01211873 (4) [back to overview]"MRI Lesion Visualization (Border Delineation, Internal Morphology and Contrast Enhancement) at Patient Level for Both Pre and Paired Evaluation"
NCT01211873 (4) [back to overview]Diagnostic Confidence Score
NCT01254552 (1) [back to overview]Prevalence of Occult Myocardial Scar on Delayed-enhanced MRI in Asymptomatic Patients With Type 2 Diabetes Mellitus
NCT01449266 (4) [back to overview]Percent Change in Gadolinium Serum Concentration 4h After Second Hemodialysis Session, Estimated From Subjects With Concentration Data Above the Limit of Detection
NCT01449266 (4) [back to overview]Dialysability of Dotarem® in Dialysed Patients
NCT01449266 (4) [back to overview]Safety of Dotarem® in Dialysed Patients Evaluated by the Number of Patients Experiencing Adverse Events.
NCT01449266 (4) [back to overview]Percent Change in Gadolinium Serum Concentration 4h After Third Hemodialysis Session, Estimated From Subjects With Concentration Data Above the Limit of Detection
NCT01806740 (4) [back to overview]Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Time to Progression
NCT01806740 (4) [back to overview]Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Progression Free Survival
NCT01806740 (4) [back to overview]Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Overall Survival
NCT01806740 (4) [back to overview]Correlation Coefficient Between DCE-MRI Perfusion Parameters and the Response of Target Lesions to Sorafenib
NCT02411201 (7) [back to overview]MRI Lesion Visualization at Subject Level
NCT02411201 (7) [back to overview]Simulated Plasma Concentration of DOTAREM
NCT02411201 (7) [back to overview]Area Under the Curve of DOTAREM in Plasma
NCT02411201 (7) [back to overview]Rate Constant of the Terminal Phase of DOTAREM
NCT02411201 (7) [back to overview]Terminal Elimination Half-life of DOTAREM From Plasma
NCT02411201 (7) [back to overview]Total Clearance of DOTAREM From Plasma
NCT02411201 (7) [back to overview]Volume of Distribution of DOTAREM at Steady State
NCT02431598 (6) [back to overview]Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale
NCT02431598 (6) [back to overview]O2 Saturation Following Contrast Administration
NCT02431598 (6) [back to overview]Percentage of Participants With Transient Severe Motion (TSM) Based on Presence of Motion Artifacts at Arterial Phase Imaging
NCT02431598 (6) [back to overview]Subject Breath Hold Capacity, as Measured by Number of Seconds a Subject Can Hold His/Her Breath
NCT02431598 (6) [back to overview]Subject-reported Dyspnea, as Measured by Questionnaire Responses
NCT02431598 (6) [back to overview]Heart Rate Following Contrast Injection
NCT02899377 (14) [back to overview]Net Irreversible Influx Rate Constant (Ki) From 11C-MET PET/CT
NCT02899377 (14) [back to overview]SUV for 11C- MET in Selected Body Areas
NCT02899377 (14) [back to overview]Correlation Between Static and Dynamic Imaging Metrics in 11C-MET
NCT02899377 (14) [back to overview]Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas
NCT02899377 (14) [back to overview]Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D)
NCT02899377 (14) [back to overview]Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction
NCT02899377 (14) [back to overview]Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans)
NCT02899377 (14) [back to overview]TR Ratio of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants
NCT02899377 (14) [back to overview]TR Ratio for 11C- MET of Salivary Glands, Lachrymal Gland, Parotid Gland, and Submandibular Gland
NCT02899377 (14) [back to overview]Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC)
NCT02899377 (14) [back to overview]TR Ratio for 11C- MET
NCT02899377 (14) [back to overview]Tissue to Reference (TR) Ratio for 18F- FDG for pSS Participants
NCT02899377 (14) [back to overview]SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants
NCT02899377 (14) [back to overview]SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET
NCT03041298 (5) [back to overview]Cytology Test Results (Percentage of Patients Per Cytology Test Result)
NCT03041298 (5) [back to overview]Diagnostic Results (Percentage of Patients Per Diagnosis)
NCT03041298 (5) [back to overview]Image Quality
NCT03041298 (5) [back to overview]Ability to Make a Diagnosis
NCT03041298 (5) [back to overview]Frequency of Adverse Drug Reactions
NCT03048006 (2) [back to overview]Frequency of Adverse Events
NCT03048006 (2) [back to overview]Image Quality
NCT03602339 (12) [back to overview]Comparison of Internal Morphology Detected by Blinded Readers for Combined Image Sets - Equivalence Test
NCT03602339 (12) [back to overview]Confidence in Diagnosis
NCT03602339 (12) [back to overview]Image Quality
NCT03602339 (12) [back to overview]Number of Lesions Identified
NCT03602339 (12) [back to overview]Contrast Enhancement Utilizing an Exploratory Overall Contrast Enhancement Estimation Algorithm
NCT03602339 (12) [back to overview]Degree of Lesion Contrast Enhancement
NCT03602339 (12) [back to overview]Lesion Border Delineation
NCT03602339 (12) [back to overview]Number of Participants With Treatment-emergent Adverse Events
NCT03602339 (12) [back to overview]Comparison of Border Delineation Detected by Blinded Readers for Combined Image Sets - Equivalence Test
NCT03602339 (12) [back to overview]Lesion Internal Morphology
NCT03602339 (12) [back to overview]Detection of Malignant Disease
NCT03602339 (12) [back to overview]Comparison of Degree of Lesion Contrast Enhancement Detected by Blinded Readers for Combined Image Sets - Equivalence Test

eGFR Values Variation Between Baseline and 72±24 Hours After Examination, in the Per Protocol Population

eGFR (estimated Glomerular Filtration Rate) was assessed using creatinemia and the Modification of Diet in Renal Disease (MDRD) study equation. eGFR were evaluated in terms of mean difference between the pre- and post-MRI procedure. The eGFR variation was expressed as a percentage of change from baseline values. (NCT00650845)
Timeframe: Baseline pre MRI and 3 days post MRI

InterventionPercentage of change from baseline (Mean)
Dotarem®-Enhanced MRI1.37
Non-enhanced MRI7.58

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Number of Patients Presenting Contrast-induced Nephropathy as Defined by an Increase in Serum Creatinine Levels of a Least 25% Over Baseline Levels, in the Full Analysis Set Population.

Comparing the number of patients experiencing an increase of creatinine of at least 25% over baseline levels after Dotarem®-enhanced MRI and after non-enhanced MRI in patients with at least a moderate renal insufficiency. (NCT00650845)
Timeframe: baseline pre MRI and 3 days post MRI

InterventionNumber of patients (Number)
Dotarem®-Enhanced MRI1
Non-enhanced MRI0

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Number of Patients Presenting Contrast-induced Nephropathy as Defined by an Increase in Serum Creatinine Levels of at Least 25% Over Baseline Levels, in the Per Protocol Population.

Comparing the number of patients experiencing an increase of creatinine of at least 25% over baseline levels after Dotarem®-enhanced MRI and after non-enhanced MRI in patients with at least a moderate renal insufficiency. (NCT00650845)
Timeframe: Baseline pre MRI and 3 days post MRI

InterventionNumber of patients (Number)
Dotarem®-Enhanced MRI1
Non-enhanced MRI0

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Percent Change of Estimated Glomerular Filtration Rate (eGFR) Values From Baseline to 72±24 Hours After Examination, in the Full Analysis Set Population

eGFR was assessed using creatinemia and the Modification of Diet in Renal Disease (MDRD) study equation. eGFR were evaluated in terms of mean difference between the pre- and post-MRI procedure. The eGFR variation was expressed as a percentage of change from baseline values. (NCT00650845)
Timeframe: Baseline pre MRI and 3 days post MRI

InterventionPercentage of change from baseline (Mean)
Dotarem®-Enhanced MRI3.02
Non-enhanced MRI5.55

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Percent Change of Serum Creatinine Level From Baseline to 72±24 Hours After Examination, in the Full Analysis Set Population.

Serum creatinine levels were measured at baseline and at 72±24 hours after examination. The percentage of change in creatinemia from baseline was calculated for both the Dotarem® and the non-enhanced groups. (NCT00650845)
Timeframe: Baseline pre MRI and 3 days post MRI

InterventionPercentage of change from baseline (Mean)
Dotarem®-Enhanced MRI-1.40
Non-enhanced MRI-3.48

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Percent Change of Serum Creatinine Level Variation From Baseline to 72±24 Hours After Examination, in the Per Protocol Population

Serum creatinine levels were measured at baseline and at 72±24 hours after examination. The percentage of change in creatinemia from baseline was calculated for both the Dotarem® and the non-enhanced groups. (NCT00650845)
Timeframe: Baseline pre MRI and 3 days post MRI

InterventionPercentage of change from baseline (Mean)
Dotarem®-Enhanced MRI0.05
Non-enhanced MRI-5.17

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Percent of Non Assessable Renal Artery Segments

For each examination (TOF and Dotarem-enhanced MRA) the percent of non-assessable segments will be compared (NCT00980681)
Timeframe: 1 to 7 days

Interventionpercentage of non-assessable segments (Number)
Dotarem-enhanced MRA25
Time-Of-Flight MRA20

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Technical Failure Rate

Rate of non-assessable arterial segments as measured by 3 independent readers in off-site evaluation of TOF-MRA and Dotarem-enhanced MRA (re-read DGD-44-060). (NCT01010932)
Timeframe: 2 - 28 days

,
Interventionpercentage of arterial segments (Number)
Reader 1Reader 2Reader 3
Dotarem-enhanced MRA4.651.772.20
TOF MRA29.4416.7018.54

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Specificity

Rate of true non-stenotic segments (i.e. without stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-060). (NCT01010932)
Timeframe: 2 - 42 days

,
Interventionpercentage of non-stenotic segments (Number)
Reader 1Reader 2Reader 3
Dotarem-enhanced MRA98.1398.5198.63
TOF MRA85.4390.3990.42

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Sensitivity

Rate of true stenotic segments (i.e. with stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-060). (NCT01010932)
Timeframe: 2-42 days

,
Interventionpercentage of stenotic segments (Number)
Reader 1Reader 2Reader 3
Dotarem-enhanced MRA58.4663.0853.85
TOF MRA53.8563.0849.23

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Specificity

Rate of true non-stenotic segments (i.e. without stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-061). (NCT01012674)
Timeframe: 2 - 42 days

,
Interventionpercentage of arterial segments (Number)
Reader 1Reader 2Reader 3
Dotarem-enhanced MRA98.0398.4098.61
TOF MRA84.3489.5188.40

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Sensitivity

Rate of true stenotic segments (i.e. with stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-061). (NCT01012674)
Timeframe: 2-42 days

,
Interventionpercentage of arterial segments (Number)
Reader 1Reader 2Reader 3
Dotarem-enhanced MRA70.6569.5775.00
TOF MRA65.2273.9166.30

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Technical Failure Rate

Rate of non-assessable arterial segments as measured by 3 independent readers in off-site evaluation of TOF-MRA and Dotarem-enhanced MRA (re-read DGD-44-061). (NCT01012674)
Timeframe: 2 - 28 days

,
Interventionpercentage of arterial segments (Number)
Reader 1Reader 2Reader 3
Dotarem-enhanced MRA3.551.571.68
TOF MRA29.2217.6523.07

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Intra-patient Accuracy (Percent Agreement), On-site Data

intra-patient accuracy (percent agreement) of each type of MRA examination (Dotarem® or Gadovist®-enhanced MRA) in assessing the lesions of the concerned territory as compared with the gold standard, X-ray angiography. (NCT01026389)
Timeframe: up to one month

Interventionpercentage of agreement (Mean)
Gadovist77.1
Dotarem, Interventional80.6

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Intra-patient Accuracy, in Off-site Readings

• Intra-patient accuracy (percent agreement) of each type of MRA examination (Dotarem® or Gadovist®-enhanced MRA) in assessing the lesions of the concerned territory as compared with the gold standard, X-ray angiography, in off-site readings, using the same methodology as that used for the primary criterion (NCT01026389)
Timeframe: up to one month

Interventionpercentage of agreement (Mean)
Gadovist75.1
Dotarem, Interventional73.9

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Sensitivity

sensitivity of Dotarem® and Gadovist®-enhanced MRA examinations at the segment and the patient levels (gold standard = x-ray angiography) in on-site; moderate, severe stenosis and occlusion were grouped as one class (significant stenosis = positive segment). (NCT01026389)
Timeframe: up to one month

Interventionpositive segment with MRA (Number)
Gadovist168
Dotarem, Interventional191

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Specificity

Specificity of Dotarem® and Gadovist®-enhanced MRA examinations at the segment and the patient levels (gold standard = x-ray angiography) in on-site readings; no stenosis and non significant stenosis were grouped as one class (non significant stenosis = negative segment). (NCT01026389)
Timeframe: up to one month

Interventionnegative segments in MRA (Number)
Gadovist756
Dotarem, Interventional763

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Number of Lesions

The number of lesions for which observations could be made was calculated for each MRI modality and results are summarized per patient (NCT01211873)
Timeframe: up to 24 hours

,,,
InterventionNumber of lesions (Mean)
Reader 1Reader 2Reader 3
Dotarem (Gadoterate Meglumine) - PAIRED2.693.162.46
Dotarem (Gadoterate Meglumine) - PRE1.972.291.97
Magnevist (Gadopentetate Dimeglumine) - PAIRED4.194.503.97
Magnevist (Gadopentetate Dimeglumine) - PRE1.982.602.15

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Image Quality Score

Image quality was evaluated for each lesion according to a 3-point scale with the following grades; poor (1), fair (2) or good (3), and an overall score per patient was calculated. At patient level, the maximum score is 3, minimum score is 1. Higher scores mean a better image quality. (NCT01211873)
Timeframe: up to 24 hours

,,,
Interventionunits on a scale (Mean)
Reader 1Reader 2Reader 3
Dotarem (Gadoterate Meglumine) - PAIRED2.983.002.99
Dotarem (Gadoterate Meglumine) - PRE1.411.722.00
Magnevist (Gadopentetate Dimeglumine) - PAIRED2.962.982.99
Magnevist (Gadopentetate Dimeglumine) - PRE1.421.741.99

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"MRI Lesion Visualization (Border Delineation, Internal Morphology and Contrast Enhancement) at Patient Level for Both Pre and Paired Evaluation"

"To demonstrate the superiority of combined unenhanced and Dotarem enhanced MRI (PAIRED) compared to unenhanced MRI (PRE) in terms of lesion visualization.~Unenhanced MRI refers to MRI before administration of contrast agent. Enhanced MRI refers to MRI after contrast agent injection. Pre refers to unenhanced MRI. PAIRED refer to combined unenhanced and enhanced MRI.~The measure used a specific scale with 3-point levels to assess lesion visualization. At lesion level, the scale range is from 0 through 1 to 2. Score 0 means a worse outcome and score 2 means a better outcome. Patient score is the sum of all lesion scores. Up to 5 of the largest representative lesions were assessed. At patient level, the maximum score is 10, minimum score is 0." (NCT01211873)
Timeframe: up to 24 hours

,
Interventionunits on a scale (Mean)
Border Delineation Blinded Reader 1Border Delineation Blinded Reader 2Border Delineation Blinded Reader 3Internal Morphology Blinded Reader 1Internal Morphology Blinded Reader 2Internal Morphology Blinded Reader 3Contrast Enhancement Blinded Reader 1Contrast Enhancement Blinded Reader 2Contrast Enhancement Blinded Reader 3
Dotarem (Gadoterate Meglumine) - PAIRED3.304.492.543.704.492.933.113.732.95
Dotarem (Gadoterate Meglumine) - PRE1.061.621.430.971.761.450.010.010.01

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Diagnostic Confidence Score

Level of diagnostic confidence when evaluating the MRI modalities was graded using a 5-point scale as nil (1), poor (2), moderate (3), high (4) and excellent (5). (NCT01211873)
Timeframe: up to 24 hours

,,,
Interventionunits on a scale (Mean)
Reader 1Reader 2Reader 3
Dotarem (Gadoterate Meglumine) - PAIRED4.594.894.41
Dotarem (Gadoterate Meglumine) - PRE3.042.843.47
Magnevist (Gadopentetate Dimeglumine) - PAIRED4.664.924.59
Magnevist (Gadopentetate Dimeglumine) - PRE3.112.853.59

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Prevalence of Occult Myocardial Scar on Delayed-enhanced MRI in Asymptomatic Patients With Type 2 Diabetes Mellitus

(NCT01254552)
Timeframe: From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)

InterventionParticipants (Count of Participants)
Intention To Treat Population23

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Percent Change in Gadolinium Serum Concentration 4h After Second Hemodialysis Session, Estimated From Subjects With Concentration Data Above the Limit of Detection

Evaluation of the decrease in seric concentration of gadolinium, 4h after the second hemodialysis session of patients injected with 0.1 mmol/kg of Dotarem®. The percent change of gadolinium concentration was estimated from the concentration of gadolinium after Dotarem® injection. Only subjects with gadolinium concentration above the lower limit of quantification (LLQ) were kept for analysis. (NCT01449266)
Timeframe: Dotarem® dialysability assessed 4h after second hemodialysis session which took place 2 days after Dotarem® administration

InterventionPercent change in Gd concentration (Geometric Mean)
Dotarem® Injected Patients-99.5

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Dialysability of Dotarem® in Dialysed Patients

To evaluate the decrease in seric concentration of gadolinium, after each hemodialysis session of patients injected with 0.1 mmol/kg of Dotarem® . The percent change of gadolinium concentration is calculated by estimating the amount of serum gadolinium before and after each hemodialysis session. Calculations are performed only for subjects with concentration above the lower limit of quantification (LLQ) (NCT01449266)
Timeframe: Dotarem® dialysability assessed up to 4 days after Dotarem® administration

Interventionpercent change in Gd concentration (Geometric Mean)
Percent change at 0.5h after first hemodialysisPercent change at 1.5h after first hemodialysisPercent change at 4h after first hemodialysisPercent change at 4h after second hemodialysis n=7Percent change at 4h after third hemodialysis n=2
Dotarem® Injected Patients-88.2-93.4-97.1-94.8-89.9

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Safety of Dotarem® in Dialysed Patients Evaluated by the Number of Patients Experiencing Adverse Events.

To evaluate the biological and clinical safety of Dotarem® by assessing vital signs, biological parameters, injection-site tolerance, through a 4-day post injection follow-up, adverse events through a 3-week post injection period and serious adverse events through a 3-month post injection period. (NCT01449266)
Timeframe: Safety assessed from patients inclusion until the last follow-up visit 3 months after Dotarem® administration

Interventionparticipants (Number)
Dotarem® Injected Patients8

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Percent Change in Gadolinium Serum Concentration 4h After Third Hemodialysis Session, Estimated From Subjects With Concentration Data Above the Limit of Detection

The evaluation of the decrease in seric concentration of gadolinium, 4h after the third hemodialysis session of patients injected with 0.1 mmol/kg of Dotarem®. The percent change of gadolinium concentration was estimated from the concentration of gadolinium after Dotarem® injection. Only subjects with gadolinium concentration above the lower limit of detection were kept for analysis. (NCT01449266)
Timeframe: Dotarem® dialysability assessed 4h after third hemodialysis session which took place 4 days after Dotarem® administration

Interventionpercent change in Gd concentration (Geometric Mean)
Dotarem® Injected Patients-99.7

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Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Time to Progression

"To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, wash-in, washout) at baseline and time to progression.~The time to progression was calculated from the patient's survival status and tumor progression status recorded one year after initiation of the sorafenib treatment.~The correlation analyses were done using Pearson or Spearman correlation coefficient." (NCT01806740)
Timeframe: 1 year

Interventioncorrelation coefficient (Number)
Ktrans (mean)AUC (mean)ve (mean)kep (mean)T1 (mean)Wash-in (mean)Washout (mean)
Baseline-0.72-0.64-0.68-0.170.24-0.70-0.42

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Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Progression Free Survival

"To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, wash-in, washout) at baseline and progression free survival.~The progression free survival was calculated from the patient's survival status and tumor progression status recorded one year after initiation of the sorafenib treatment.~The correlation analyses were done using Pearson or Spearman correlation coefficient." (NCT01806740)
Timeframe: 1 year

Interventioncorrelation coefficient (Number)
Ktrans (mean)AUC (mean)ve (mean)kep (mean)T1 (mean)Wash-in (mean)Washout (mean)
Baseline-0.24-0.450.17-0.23-0.15-0.31-0.29

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Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Overall Survival

"To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, wash-in, washout) at baseline and overall survival.~The overall survival was calculated from the patient's survival status recorded one year after initiation of the sorafenib treatment.~The correlation analyses were done using Pearson or Spearman correlation coefficient." (NCT01806740)
Timeframe: 1 year

Interventioncorrelation coefficient (Number)
Ktrans (mean)AUC (mean)ve (mean)kep (mean)T1 (mean)Wash-in (mean)Washout (mean)
Baseline0.09-0.080.35-0.05-0.14-0.02-0.04

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Correlation Coefficient Between DCE-MRI Perfusion Parameters and the Response of Target Lesions to Sorafenib

"To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, Wash-in, Washout) at baseline, week 1 and week 2, and the response of target lesions to sorafenib.~Ktrans: volume transfer constant between blood plasma and extravascular extracellular space~AUC : area under the curve of tissue gadolinium concentration-time~ve: fractional volume of extravascular extracellular space~kep: rate constant between extravascular extracellular space and blood plasma (=Ktrans/ve)~T1: longitudinal relaxation time~Wash-in: slope of the early enhancement curve~Washout: slope of the late enhancement curve~The response of target lesions was assessed by mRECIST at 2 months after initiation of treatment (sorafenib).~The correlation analyses were done using Pearson or Spearman correlation coefficient." (NCT01806740)
Timeframe: 3 months

,,
Interventioncorrelation coefficient (Number)
Ktrans (mean)AUC (mean)ve (mean)kep (mean)T1 (mean)Wash-in (mean)Washout (mean)
Baseline-0.29-0.53-0.19-0.070.05-0.42-0.31
Week 1-0.38-0.60-0.33-0.240.30-0.48-0.48
Week 2-0.38-0.62-0.34-0.170.18-0.52-0.36

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MRI Lesion Visualization at Subject Level

"Lesion visualization was assessed on up to five most representative lesions per subject based on scoring of 3 co-endpoints:~border delineation (based on a 3-point scale where 1=none; 2=moderate and 3=clear and complete)~internal morphology (based on a 3-point scale where 1=poorly visible; 2=moderately visible and 3=sufficiently visible)~contrast enhancement (based on a 3-point scale where 1=none; 2=weak and 3=clear and bright)~For each co-endpoint, a sum of scores was calculated at subject level as follows: sum of scores = score of the lesion 1 (+ score of the lesion 2 + score of the lesion 3 + score of the lesion 4 + score of the lesion 5, when applicable)" (NCT02411201)
Timeframe: Pre-injection and post-injection (estimated between 5 and 20 minutes after injection)

,
Interventionunits on a scale (Mean)
Sum of scores of lesion border delineationSum of scores of internal morphologySum of scores of contrast enhancement
Pre- + Post-contrast5.15.25.0
Pre-contrast4.34.31.9

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Simulated Plasma Concentration of DOTAREM

Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method. (NCT02411201)
Timeframe: at 10 and 20 min post-injection

Interventionµmol/L (Median)
Simulated concentration at 10 minSimulated concentration at 20 min
DOTAREM320.92275.67

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Area Under the Curve of DOTAREM in Plasma

Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method. Area under the curve was determined from typical and individual DOTAREM concentration-time profiles. (NCT02411201)
Timeframe: Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection

Interventionhour.µmol/L (Median)
DOTAREM1591.1

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Rate Constant of the Terminal Phase of DOTAREM

Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method. Rate constant of the terminal phase was determined from typical and individual DOTAREM concentration-time profiles. (NCT02411201)
Timeframe: Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection

Interventionhour-1 (Median)
DOTAREM0.5117

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Terminal Elimination Half-life of DOTAREM From Plasma

Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method. Terminal elimination half-life was determined from typical and individual DOTAREM concentration-time profiles. (NCT02411201)
Timeframe: Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection

Interventionhour (Mean)
DOTAREM1.3545

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Total Clearance of DOTAREM From Plasma

Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method. Total clearance was determined from typical and individual DOTAREM concentration-time profiles. (NCT02411201)
Timeframe: Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection

InterventionL/hour per kg (Mean)
DOTAREM0.0602

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Volume of Distribution of DOTAREM at Steady State

Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method. Volume of distribution at steady state was determined from typical and individual DOTAREM concentration-time profiles. (NCT02411201)
Timeframe: Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection

InterventionL/kg (Mean)
DOTAREM0.0473

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Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale

"no motion artifact~minimal motion artifact~moderate motion artifact~severe motion artifact~extensive motion artifact" (NCT02431598)
Timeframe: following contrast administration, up to 5 minutes

,,,
Interventionscores on a scale (Mean)
EovistNormal SalineDotarem
Arterial Phase2.72.32.2
Last Dynamic Phase2.32.12.3
Portal Venous Phase2.42.22.3
Pre-Contrast Phase2.32.12.2

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O2 Saturation Following Contrast Administration

(NCT02431598)
Timeframe: following contrast administration, up to 5 minutes

Interventionpercentage (Mean)
Eovist (Gadoxetate Disodium)98
Dotarem (Gadoterate Dimeglumine)98
Saline98

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Percentage of Participants With Transient Severe Motion (TSM) Based on Presence of Motion Artifacts at Arterial Phase Imaging

Arterial-phase breath-holding duration and motion artifacts after each agent were compared using the Mann-Whitney-U test and the McNemar test. (NCT02431598)
Timeframe: following contrast administration, up to 5 minutes

Interventionpercentage of participants with TSM (Number)
Eovist (Gadoxetate Disodium)7
Dotarem (Gadoterate Dimeglumine)2
Saline0

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Subject Breath Hold Capacity, as Measured by Number of Seconds a Subject Can Hold His/Her Breath

(NCT02431598)
Timeframe: following contrast administration, up to 5 minutes

Interventionseconds (Median)
Eovist (Gadoxetate Disodium)28
Dotarem (Gadoterate Dimeglumine)38
Saline35

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Subject-reported Dyspnea, as Measured by Questionnaire Responses

After each breath-hold, the MRI technologist asked the volunteer through the scanner microphone the following two questions, with responses based on a 5-point scale: A) How difficult was it to hold your breath? (1-Not at all; 5-Very difficult); B) Do you feel short of breath now? (1-Not at all; 5-Very short of breath). Responses were recorded for each breath-hold. (NCT02431598)
Timeframe: following contrast administration, up to 5 minutes

,,
Interventionunits on a scale (1-5) (Mean)
Question AQuestion B
Dotarem (Gadoterate Dimeglumine)1.71.1
Eovist (Gadoxetate Disodium)2.41.3
Saline1.81.1

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Heart Rate Following Contrast Injection

Heart rate following contrast injection (NCT02431598)
Timeframe: following contrast administration, up to 5 minutes

Interventionbeats per minute (Mean)
Eovist (Gadoxetate Disodium)70
Dotarem (Gadoterate Dimeglumine)70
Saline70

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Net Irreversible Influx Rate Constant (Ki) From 11C-MET PET/CT

Blood samples were collected at indicated time points for radio-pharmacokinetic analysis of Ki. Pharmacokinetic (PK) Population included those participants in the 'Safety' population for whom a radio-pharmacokinetic sample was obtained and analyzed. Data for lower value of region (low), higher value of region (high) and right-left combined values (aggregated) is presented. (NCT02899377)
Timeframe: 0.1, 0.4, 0.6, 0.9, 1.1, 1.4, 1.6, 1.9, 2.5, 3.5, 4.5, 6.0, 8, 10, 12, 14, 17.5, 22.5, 27.5, 32.5 and 37.5 minutes post-injection

,
InterventionMilliliter/centimeter cube/minute (Mean)
Parotid Gland, LowParotid Gland, HighParotid Gland, AggregatedSubmandibular Gland, LowSubmandibular Gland, HighSubmandibular Gland, Aggregated
Healthy Participants0.05740.06080.05930.05980.06260.0614
Participants With pSS0.04250.04720.04480.03830.04220.0407

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SUV for 11C- MET in Selected Body Areas

Semi-quantitative parameters used for the assessment of uptake included Mean, Peak and Max SUV for following selected body areas: aorta, liver, muscle, lumbar vertebra, pancreas, salivary gland, spleen, and thyroid. Data from static scan is reported. (NCT02899377)
Timeframe: Visit 1: Within 6 weeks after Baseline

,
InterventionGrams per milliliter (Mean)
Aorta, Max SUVLiver, Max SUVLumbar Vertebra, Max SUVMuscle, Max SUVPancreas, Max SUVSalivary gland, Max SUVSpleen, Max SUVThyroid, Max SUVAorta, Mean SUVLiver, Mean SUVLumbar Vertebra, Mean SUVMuscle, Mean SUVPancreas, Mean SUVSpleen, Mean SUVThyroid, Mean SUVAorta, Peak SUVLiver, Peak SUVLumbar Vertebra, Peak SUVMuscle, Peak SUVPancreas, Peak SUVSalivary gland, Peak SUVSpleen, Peak SUVThyroid, Peak SUV
Healthy Participants2.027516.42135.91002.351331.73886.69005.27503.10381.0298.9162.9230.92616.5562.4231.6461.133812.34383.87751.310026.79135.06003.41002.0525
Participants With pSS2.270019.16677.17332.416731.44925.42755.51003.70581.16110.9263.4850.96816.4132.6502.1491.325014.78084.73171.367526.46833.36333.69752.6000

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Correlation Between Static and Dynamic Imaging Metrics in 11C-MET

Blood samples were collected at indicated time points for analysis. Pearson's correlation is presented along with 95% confidence interval. (NCT02899377)
Timeframe: 0.1, 0.4, 0.6, 0.9, 1.1, 1.4, 1.6, 1.9, 2.5, 3.5, 4.5, 6.0, 8, 10, 12, 14, 17.5, 22.5, 27.5, 32.5 and 37.5 minutes post-injection

,
InterventionGrams per milliliter (Number)
Max SUV, LowMax SUV, HighMax SUV, AggregatedMean SUV, LowMean SUV, HighPeak SUV, LowPeak SUV, HighPeak SUV, Aggregated
Healthy Participants-0.066-0.106-0.1000.1420.1300.0450.0530.038
Participants With pSS0.9150.8840.8910.8950.7860.9290.8660.906

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Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas

Semi-quantitative parameters used for the assessment of glucose uptake included Mean, Peak and Max SUV for following selected body areas: aorta, liver, muscle, pancreas, lumbar vertebra, salivary gland, spleen, and thyroid. Safety Population included all participants who underwent any procedure on or after Visit 1. (NCT02899377)
Timeframe: Visit 1: Within 6 weeks after Baseline

InterventionGrams per milliliter (Mean)
Aorta, Max SUVLiver, Max SUVLumbar Vertebra, Max SUVMuscle, Max SUVPancreas, Max SUVSalivary gland, Max SUVSpleen, Max SUVThyroid, Max SUVAorta, Mean SUVLiver, Mean SUVLumbar Vertebra, Mean SUVMuscle, Mean SUVPancreas, Mean SUVSpleen, Mean SUVThyroid, Mean SUVAorta, Peak SUVLiver, Peak SUVLumbar Vertebra, Peak SUVMuscle, Peak SUVPancreas, Peak SUVSalivary gland, Peak SUVSpleen, Peak SUVThyroid, Peak SUV
Participants With pSS2.90675.06834.02251.45584.27003.10673.23333.14081.8832.2732.1050.6571.8741.7511.8222.01253.27002.82420.88332.68922.14252.34752.2458

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Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D)

Quantitative parameters like pure D assessed the use of multi-parametric MRI in the assessment of uptake in selected body areas like lachrymal gland, parotid gland, and submandibular gland. The median and IQR values for pure D was used for analysis. Data for lower value of region, higher value of region, and aggregated value which includes left and right region combined value has been reported. (NCT02899377)
Timeframe: Visit 1: Within 6 weeks after Baseline

,
Intervention10^-3 square millimeter per second (Mean)
Parotid Gland, Low, IQR, n=12, 11Parotid Gland, High, IQR, n=12, 11Parotid Gland, Aggregated, IQR, n=12, 11Submandibular Gland, Low, IQR, n=12, 10Submandibular Gland, High, IQR, n=12, 10Submandibular Gland, Aggregated, IQR, n=12, 11Parotid Gland, Low, Median, n=12, 11Parotid Gland, High, Median, n=12, 11Parotid Gland, Aggregated, Median, n=12, 11Submandibular Gland, Low, Median, n=12, 10Submandibular Gland, High, Median, n=12, 10Submandibular Gland, Aggregated, Median, n=12, 11
Healthy Participants0.4370.5030.4680.5530.7330.6360.7710.8070.7870.9411.0350.993
Participants With pSS0.4490.5290.4930.5470.6810.6080.6210.7150.6760.7330.8140.807

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Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction

Quantitative parameters like Microvascular Volume Fraction assessed use of multi-parametric MRI in selected body areas like lachrymal gland, parotid gland, and submandibular gland. The median and IQR values were used for analysis. Data for lower value of region, higher value of region, and aggregated value which includes left and right region combined value has been reported. The IVIM (intra-voxel incoherent motion) model estimates two separate pools of diffusion (for a microvascular component and a tissue component). Pool one describes fraction (f) of the signal. Pool two describes fraction (1-f) of the signal. Microvascular Volume Fraction (f) is the ratio of the signal contribution of the microvascular pool (pool one) over the entire signal. (NCT02899377)
Timeframe: Visit 1: Within 6 weeks after Baseline

,
InterventionRatio (Mean)
Parotid Gland, Low, IQR, n=12, 11Parotid Gland, High, IQR, n=12, 11Parotid Gland, Aggregated, IQR, n=12, 11Submandibular Gland, Low, IQR, n=12, 10Submandibular Gland, High, IQR, n=12, 10Submandibular Gland, Aggregated, IQR, n=12, 11Parotid Gland, Low, Median, n=12, 11Parotid Gland, High, Median, n=12, 11Parotid Gland, Aggregated, Median, n=12, 11Submandibular Gland, Low, Median, n=12, 10Submandibular Gland, High, Median, n=12, 10Submandibular Gland, Aggregated, Median, n=12, 11
Healthy Participants0.1350.1640.1490.2040.2330.2190.1310.1510.1400.1980.2230.210
Participants With pSS0.1350.1720.1560.2050.2330.2170.1390.1640.1510.2380.2710.243

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Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans)

Quantitative parameters like KTrans assessed use of multi-parametric MRI in the assessment of uptake in selected body areas like lachrymal gland, parotid gland, and submandibular gland. The median and IQR values were used for analysis. Data for lower value of region, higher value of region, and aggregated value which includes left and right region combined value has been reported. (NCT02899377)
Timeframe: Visit 1: Within 6 weeks after Baseline

,
InterventionPer minute (Mean)
Parotid Gland, Low, IQR, n=12, 12Parotid Gland, High, IQR, n=12, 12Parotid Gland, Aggregated, IQR, n=12, 12Submandibular Gland, Low, IQR, n=9, 8Submandibular Gland, High, IQR, n=9, 8Submandibular Gland, Aggregated, IQR, n=11, 11Parotid Gland, Low, Median, n=12, 12Parotid Gland, High, Median, n=12, 12Parotid Gland, Aggregated, Median, n=12, 12Submandibular Gland, Low, Median, n=9, 8Submandibular Gland, High, Median, n=9, 8Submandibular Gland, Aggregated, Median, n=11,11
Healthy Participants7.61812.82110.7015.54815.19210.1915.5988.8417.06112.78917.31512.146
Participants With pSS22.49230.19927.2130.45919.9141.8013.3269.3237.4500.7751.6061.421

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TR Ratio of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants

Semi-quantitative parameters used for the assessment of glucose uptake included TR ratio for following selected body areas: lachrymal gland, parotid gland, and submandibular gland. Data for lower value of region (low), higher value of region (high), and aggregated value which includes left and right region combined value has been reported. (NCT02899377)
Timeframe: Visit 1: Within 6 weeks after Baseline

InterventionRatio (Mean)
Lachrymal gland, LowLachrymal gland, HighLachrymal gland, AggregatedParotid gland, LowParotid gland, HighParotid gland, AggregatedSubmandibular gland, LowSubmandibular gland, HighSubmandibular gland, Aggregated
Participants With pSS0.85290.92010.88641.11581.23381.17491.04721.29531.1711

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TR Ratio for 11C- MET of Salivary Glands, Lachrymal Gland, Parotid Gland, and Submandibular Gland

Semi-quantitative parameters used for the assessment of uptake included TR ratio for following selected body areas: lachrymal gland, parotid gland, and submandibular gland. Data from static scan for lower value of region (low), higher value of region (high), and aggregated value which includes left and right region combined value has been reported. (NCT02899377)
Timeframe: Visit 1: Within 6 weeks after Baseline

,
InterventionRatio (Mean)
Lachrymal gland, LowLachrymal gland, HighLachrymal gland, AggregatedParotid gland, LowParotid gland, HighParotid gland, AggregatedSubmandibular gland, LowSubmandibular gland, HighSubmandibular gland, Aggregated
Healthy Participants1.82192.19652.00945.15705.46215.30965.02305.47965.2513
Participants With pSS1.20071.31781.25943.18103.61983.40032.57663.01262.7946

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Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC)

Quantitative parameters like ADC assessed use of multi-parametric MRI in the assessment of uptake in selected body areas like lachrymal gland, parotid gland, and submandibular gland. The median and interquartile range (IQR) values for ADC was used for analysis. Data for lower value of region (low), higher value of region (high), and aggregated value which includes left and right region combined value has been reported. (NCT02899377)
Timeframe: Visit 1: Within 6 weeks after Baseline

,
Intervention10^-3 square millimeter per second (Mean)
Parotid Gland, Low, IQR, n=12, 11Parotid Gland, High, IQR, n=12, 11Parotid Gland, Aggregated, IQR, n=12, 11Submandibular Gland, Low, IQR, n=12, 10Submandibular Gland, High, IQR, n=12, 10Submandibular Gland, Aggregated, IQR, n=12, 11Parotid Gland, Low, Median, n=12, 11Parotid Gland, High, Median, n=12, 11Parotid Gland, Aggregated, Median, n=12, 11Submandibular Gland, Low, Median, n=12, 10Submandibular Gland, High, Median, n=12, 10Submandibular Gland, Aggregated, Median, n=12, 11
Healthy Participants0.5110.5810.5440.5490.6740.6021.0911.1531.1201.4691.5401.506
Participants With pSS0.5160.6460.5820.7650.9280.8091.0111.1171.0691.4101.5511.474

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TR Ratio for 11C- MET

Semi-quantitative parameters used for the assessment of uptake included TR ratio for following selected body areas: aorta, liver, muscle, lumbar vertebra, pancreas, salivary gland, spleen, and thyroid. Data from static scan has been reported. (NCT02899377)
Timeframe: Visit 1: Within 6 weeks after Baseline

,
InterventionRatio (Mean)
AortaLiverLumbar VertebraMusclePancreasSalivary glandSpleenThyroid
Healthy Participants1.091012.86493.97311.335429.83315.28053.54142.1213
Participants With pSS1.135213.15134.11581.191423.54033.09743.28722.3002

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Tissue to Reference (TR) Ratio for 18F- FDG for pSS Participants

Semi-quantitative parameters used for the assessment of glucose uptake included TR ratio for the following selected body areas: aorta, liver, lumbar vertebra, muscle, pancreas, salivary gland, spleen, and thyroid. (NCT02899377)
Timeframe: Visit 1: Within 6 weeks after Baseline

InterventionRatio (Mean)
AortaLiverLumbar VertebraMusclePancreasSalivary glandSpleenThyroid
Participants With pSS1.06601.73661.50960.46691.43121.17301.26251.2193

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SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants

Semi-quantitative parameters used for the assessment of glucose uptake included Mean, Peak and Max SUV for following selected body areas: lachrymal gland, parotid gland, and submandibular gland. Data for lower value of region (low), higher value of region (high), and aggregated value which is left and right region combined value has been reported for the regions of interest. SUV is a mathematically derived ratio of tissue radioactivity concentration and the injected dose of radioactivity per kilogram of the participant's body weight at a given point in time. (NCT02899377)
Timeframe: Visit 1: Within 6 weeks after Baseline

InterventionGrams per milliliter (Mean)
Lachrymal gland, Low, Max SUVLachrymal gland, High, Max SUVLachrymal gland, Aggregated, Max SUVParotid gland, Low, Max SUVParotid gland, High, Max SUVParotid gland, Aggregated, Max SUVSubmandibular gland, Low, Max SUVSubmandibular gland, High, Max SUVSubmandibular gland, Aggregated, Max SUVLachrymal gland, Low, Mean SUVLachrymal gland, High, Mean SUVParotid gland, Low, Mean SUVParotid gland, High, Mean SUVSubmandibular gland, Low, Mean SUVSubmandibular gland, High, Mean SUVLachrymal gland, Low, Peak SUVLachrymal gland, High, Peak SUVLachrymal gland, Aggregated, Peak SUVParotid gland, Low, Peak SUVParotid gland, High, Peak SUVParotid gland, Aggregated, Peak SUVSubmandibular gland, Low, Peak SUVSubmandibular gland, High, Peak SUVSubmandibular gland, Aggregated, Peak SUV
Participants With pSS1.78082.06582.06582.57672.77832.77832.52002.92502.92501.3111.5151.6201.8181.7091.9161.58421.71251.64922.01502.23832.12751.92752.38832.1583

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SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET

Semi-quantitative parameters used for the assessment of uptake included Mean, Peak and Max SUV for following selected body areas: lachrymal gland, parotid gland, and submandibular gland. Data from static scan for lower value of region (low), higher value of region (high), and aggregated value which includes left and right region combined value has been reported. SUV is a mathematically derived ratio of tissue radioactivity concentration and the injected dose of radioactivity per kilogram of the participant's body weight at a given point in time. (NCT02899377)
Timeframe: Visit 1: Within 6 weeks after Baseline

,
InterventionGrams per milliliter (Mean)
Lachrymal gland, Low, Max SUVLachrymal gland, High, Max SUVLachrymal gland, Aggregated, Max SUVParotid gland, Low, Max SUVParotid gland, High, Max SUVParotid gland, Aggregated, Max SUVSubmandibular gland, Low, Max SUVSubmandibular gland, High, Max SUVSubmandibular gland, Aggregated, Max SUVLachrymal gland, Low, Mean SUVLachrymal gland, High, Mean SUVParotid gland, Low, Mean SUVParotid gland, High, Mean SUVSubmandibular gland, Low, Mean SUVSubmandibular gland, High, Mean SUVLachrymal gland, Low, Peak SUVLachrymal gland, High, Peak SUVLachrymal gland, Aggregated, Peak SUVParotid gland, Low, Peak SUVParotid gland, High, Peak SUVParotid gland, Aggregated, Peak SUVSubmandibular gland, Low, Peak SUVSubmandibular gland, High, Peak SUVSubmandibular gland, Aggregated, Peak SUV
Healthy Participants2.55133.12503.12505.90386.37506.37506.21506.54886.54881.7032.0563.5053.6483.9234.1911.77382.16881.97134.90005.16635.03254.85885.31005.0838
Participants With pSS1.91332.14832.14834.39334.94924.94923.85834.46924.46921.3121.4622.5252.9252.3882.6481.35251.49581.42333.43673.91753.67672.80253.29923.0517

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Cytology Test Results (Percentage of Patients Per Cytology Test Result)

Diagnoses were made according to the cytology test results. Percentage of patients per cytology test result was calculated. Multiple diagnoses were possible for the same patient. (NCT03041298)
Timeframe: During MRI procedure

InterventionParticipants (Count of Participants)
Invasive ductal carcinomaOtherInvasive lobular carcinomaIntraductal carcinomaFibroadenomaMucinous carcinomaInflammatory carcinomaPapillomaMedullary carcinomaInvasive papillary carcinomaTubular carcinoma
All Included Patients1096635148322111

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Diagnostic Results (Percentage of Patients Per Diagnosis)

Diagnoses were made with MR images. Percentage of patients per diagnosis was calculated. Multiple diagnoses were possible for the same patient. (NCT03041298)
Timeframe: During MRI procedure

InterventionParticipants (Count of Participants)
Benign changesNormal findingsUnilateral focal pathological findingsOtherInvasive ductal carcinomaBilateral focal pathological findingsCarcinoma in situExtensive intraductal component
All Included Patients8583241591017223127

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Image Quality

"Image quality was evaluated on a 5-point scale: excellent; good; moderate; poor and very poor." (NCT03041298)
Timeframe: During MRI procedure

InterventionParticipants (Count of Participants)
ExcellentGoodModeratePoorVery Poor
All Included Patients49589811882

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Ability to Make a Diagnosis

"Ability to make a diagnosis was evaluated by answering yes or no to the question Did the examination permit a diagnosis ?" (NCT03041298)
Timeframe: During MRI procedure

InterventionParticipants (Count of Participants)
YesNo
All Included Patients152312

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Frequency of Adverse Drug Reactions

The frequency of adverse drug reactions (serious and non-serious) that occurred following injection of Dotarem was recorded. Adverse drug reactions are adverse events related to the product administered. (NCT03041298)
Timeframe: From the beginning of the MR mammography procedure to 30-60 min after

InterventionAdverse drug reactions (Number)
All Included Patients12

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Frequency of Adverse Events

The frequency of adverse events (serious and non-serious) that occurred following injection of Dotarem was recorded. (NCT03048006)
Timeframe: From the beginning of the MRI procedure to 30-60 min after

Interventionadverse events (Number)
All Included Patients225

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Image Quality

"Image quality was evaluated with a 5-step scale from excellent to very poor (excellent/very good; good; moderate; poor and very poor)" (NCT03048006)
Timeframe: During MRI procedure

InterventionParticipants (Count of Participants)
ExcellentGoodModeratePoorVery Poor
All Included Patients2558018218516322

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Comparison of Internal Morphology Detected by Blinded Readers for Combined Image Sets - Equivalence Test

Comparison of internal morphology detected by blinded Readers for combined image sets - Equivalence Test (Full Analysis Set). Results are presented as the average Reader score. Blinded Readers scored the structure and internal morphology of up to 5 lesions using image sequences and a 3-point scale (1 - Poor = Poor visibility; 2 - Moderate = Partial visibility; 3 - Good = Sufficient visibility). (NCT03602339)
Timeframe: Up to 20 days

InterventionScores on a scale (Mean)
Gadoterate 0.1 mmol/kg BW2.503
Gadobutrol 0.075 mmol/kg BW2.484

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Confidence in Diagnosis

Diagnostic confidence detected by 3 blinded Readers, gadobutrol vs gadoterate (Full Analysis Set). Blinded Readers rated their confidence in diagnosis according to a 4-point scale (1 - Not confident; 2 - Somewhat confident; 3 - Confident; 4 - Very confident). Results for the Average Reader are reported below. (NCT03602339)
Timeframe: Up to 20 days

InterventionScores on a scale (Mean)
Gadoterate 0.1 mmol/kg BW3.272
Gadobutrol 0.075 mmol/kg BW3.348

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Image Quality

Comparison of image quality between gadobutrol and gadoterate detected by 3 blinded Readers (Full Analysis Set). Blinded Readers assessed the image quality of gadobutrol- and gadoterate-enhanced images (randomly assigned as left [L] and right [R] image positions) according to a 5-point scale (1- Image R is worse; 2 - Image R is slightly worse; 3- Image R is similar; 4 - Image R is slightly better; 5 - Image R is better). After unblinding of data, the above codes were translated into the following scale: -2 = Gadobutrol image set is worse ; -1 = Gadobutrol image set is slightly worse ; 0 = Image sets are the same ; 1 = Gadobutrol image set is slightly better; 2 = Gadobutrol image set is better. Results for the Average Reader are reported below. (NCT03602339)
Timeframe: Up to 20 days

InterventionScores on a scale (Mean)
Gadoterate 0.1 mmol/kg BW-Gadobutrol 0.075 mmol/kg BW0.00

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Number of Lesions Identified

Number of lesions identified (up to 10) detected by 3 blinded Readers. The mean (SD) number lesions in the Average Reader for gadobutrol and gadoterate in the Full Analysis Set was reported below. (NCT03602339)
Timeframe: Up to 20 days

InterventionNumber of lesions identified (Mean)
Gadoterate 0.1 mmol/kg BW2.064
Gadobutrol 0.075 mmol/kg BW2.137

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Contrast Enhancement Utilizing an Exploratory Overall Contrast Enhancement Estimation Algorithm

Comparison of contrast enhancement utilizing an overall contrast enhancement estimation algorithm (Full Analysis Set). The exploratory algorithm analyzed the overall enhancement by comparing the axial T1w (longitudinal relaxation time-weighted) enhanced images to the T1w unenhanced images. (NCT03602339)
Timeframe: Up to 20 days

,
InterventionScores on a scale (Mean)
Relative scoreFull image scoreDice score
Gadobutrol 0.075 mmol/kg BW0.185640.055730.92991
Gadoterate 0.1 mmol/kg BW0.198940.056040.92984

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Degree of Lesion Contrast Enhancement

Degree of lesion contrast enhancement is assessed by 3 blinded Readers (Full Analysis Set). Results are presented as the Average Reader score. Blinded Readers scored up to 5 lesions using image sequences and a 4-point scale (1 - No = Lesion not enhanced; 2 - Moderate = Lesion weakly enhanced; 3 - Good = Lesion clearly enhanced; 4 - Excellent = Lesion clearly and brightly enhanced). (NCT03602339)
Timeframe: Up to 20 days

,
InterventionScores on a scale (Mean)
UnenhancedCombined unenhanced/enhanced
Gadobutrol 0.075 mmol/kg BW0.8632.979
Gadoterate 0.1 mmol/kg BW0.8843.007

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Lesion Border Delineation

Lesion border delineation is assessed by 3 blinded Readers (Full Analysis Set). Results are presented as the Average Reader score. Blinded readers scored the delineation of up to 5 lesions using image sequences and a 4-point scale (1 - None = No or unclear delineation; 2 - Moderate = Partial delineation; 3 - Good = Almost clear, but incomplete delineation; 4 - Excellent = Clear and complete delineation). (NCT03602339)
Timeframe: Up to 20 days

,
InterventionScores on a scale (Mean)
UnenhancedCombined unenhanced/enhanced
Gadobutrol 0.075 mmol/kg BW2.2783.099
Gadoterate 0.1 mmol/kg BW2.2793.096

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Number of Participants With Treatment-emergent Adverse Events

Number of subjects with treatment-emergent adverse events (TEAEs) (Safety Analysis Set). TEAEs are defined as any AEs that increase in intensity or that are newly developed during the TE period for Study Period 1 or Study Period 2, where TE period for Study Period 1 goes from the first study drug administration in Study Period 1 to 24 hours post-injection, and TE period for Study Period 2 from the first study drug administration in Study Period 2 to 24 hours post-injection. (NCT03602339)
Timeframe: From the first study drug administration up to 24 hours post injection

,
InterventionParticipants (Number)
Any TEAEAny study drug-related TEAEAny TEAE related to the protocolAny TEAE leading to discontinuationAny TESAETEAE with outcome death
Gadobutrol 0.075 mmol/kg BW110000
Gadoterate 0.1 mmol/kg BW420000

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Comparison of Border Delineation Detected by Blinded Readers for Combined Image Sets - Equivalence Test

Comparison of border delineation detected by blinded Readers for combined image sets - Equivalence Test (Full Analysis Set). Results are presented as the Average Reader score. Blinded Readers scored the delineation of up to 5 lesions using image sequences and a 4-point scale (1 - None = No or unclear delineation; 2 - Moderate = Partial delineation; 3 - Good = Almost clear, but incomplete delineation; 4 - Excellent = Clear and complete delineation). (NCT03602339)
Timeframe: Up to 20 days

InterventionScores on a scale (Mean)
Gadoterate 0.1 mmol/kg BW3.096
Gadobutrol 0.075 mmol/kg BW3.099

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Lesion Internal Morphology

Lesion internal morphology is assessed by 3 blinded Readers (Full Analysis Set). Results are presented as the Average Reader score. Blinded Readers scored the structure and internal morphology of up to 5 lesions using image sequences and a 3-point scale (1 - Poor = Poor visibility; 2 - Moderate = Partial visibility; 3 - Good = Sufficient visibility) (NCT03602339)
Timeframe: Up to 20 days

,
InterventionScores on a scale (Mean)
UnenhancedCombined unenhanced/enhanced
Gadobutrol 0.075 mmol/kg BW1.8232.484
Gadoterate 0.1 mmol/kg BW1.8352.503

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Detection of Malignant Disease

"The 3 Blinded Readers had to evaluate if the diagnosis resulting from the combined images was malignant disease or not. Each blinded Reader provided a malignant yes/no response. This was compared to the final diagnosis provided by the Investigator. The majority of Readers (2 or 3 Readers agree) was used to calculate sensitivity, specificity, and accuracy - eg. Final Diagnosis - Malignant (Reader 1-yes, Reader 2-no, Reader 3-yes --- Majority Reader yes) - this would be a match for sensitivity.~The percentage of sensitivity, specificity, and accuracy of detection of malignant disease detected by 3 blinded Readers, gadobutrol versus gadoterate (Full Analysis Set) is reported below for Majority Readers." (NCT03602339)
Timeframe: Up to 20 days

,
InterventionPercentage (%) (Number)
AccuracySensitivitySpecificity
Gadobutrol 0.075 mmol/kg BW70.258.791.8
Gadoterate 0.1 mmol/kg BW70.258.791.8

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Comparison of Degree of Lesion Contrast Enhancement Detected by Blinded Readers for Combined Image Sets - Equivalence Test

"Comparison of degree of lesion contrast enhancement detected by blinded Readers for combined image sets - Equivalence Test (Full Analysis Set). Results are presented as the Average Reader score.~Blinded Readers scored up to 5 lesions using image sequences and a 4-point scale (1 - No = Lesion not enhanced; 2 - Moderate = Lesion weakly enhanced; 3 - Good = Lesion clearly enhanced; 4 - Excellent = Lesion clearly and brightly enhanced)." (NCT03602339)
Timeframe: Up to 20 days

InterventionScores on a scale (Mean)
Gadoterate 0.1 mmol/kg BW3.007
Gadobutrol 0.075 mmol/kg BW2.979

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