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technetium tc 99m sestamibi

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Description

Technetium Tc 99m Sestamibi: A technetium imaging agent used to reveal blood-starved cardiac tissue during a heart attack. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID22617237
MeSH IDM0026183

Synonyms (23)

Synonym
technetium (99mtc) sestamibi
cardiolite
99mtc sestamibi
technetium tc 99m sestamibi
109581-73-9
tc99m rp-30a
971z4w1s09 ,
technetium (99m tc) sestamibi
DB09161
sestamibi
99m tc-sestamibi
technetium tc-99m sestamibi
99m-tc sestamibi
technetium (mtc) sestamibi [inn]
sestamibi [vandf]
technetium tc-99m sestamibi kit
technetium tc 99m sestamibi [mi]
tc99m-rp-30a
technetium tc 99m sestamibi [vandf]
technetium tc-99m sestamibi kit [orange book]
technetium (99m tc) sestamibi [who-dd]
technetium tc 99m sestamibi [usan]
1-isocyano-2-methoxy-2-methylpropane;technetium

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" This multicenter Phase I and II study indicates that planar [99mTc]HEXAMIBI stress imaging is safe and compares well with 201T1 stress imaging for detection of coronary artery disease."( Technetium-99m hexakis 2-methoxyisobutyl isonitrile: human biodistribution, dosimetry, safety, and preliminary comparison to thallium-201 for myocardial perfusion imaging.
Beller, GA; Berman, DS; Boucher, CA; Fridrich, R; Holman, BL; Maddahi, J; Picard, M; Strauss, HW; Wackers, FJ; Watson, DD, 1989
)
0.28
" Adverse effects of the different adenosine dosages were compared."( Safety of different dosages of intravenous adenosine used in conjunction with diagnostic myocardial imaging techniques.
Esterbrooks, DJ; Gupta, NC; Hilleman, DE; Mohiuddin, SM,
)
0.13
"Adenosine-assisted myocardial perfusion imaging procedures are relatively safe for evaluating coronary artery disease."( Safety of different dosages of intravenous adenosine used in conjunction with diagnostic myocardial imaging techniques.
Esterbrooks, DJ; Gupta, NC; Hilleman, DE; Mohiuddin, SM,
)
0.13
"When done with the necessary caution, dobutamine myocardial perfusion imaging is a safe diagnostic test, although side effects are common."( Tolerance, hemodynamic changes, and safety of dobutamine stress perfusion imaging.
Dakik, HA; Vempathy, H; Verani, MS,
)
0.13
" Because of minimal hemodynamic effects, intravenous dipyridamole may be a safe means of producing hyperemia for myocardial perfusion imaging."( Safety of early intravenous dipyridamole technetium 99m sestamibi SPECT myocardial perfusion imaging after uncomplicated first myocardial infarction. Early Post MI IV Dipyridamole Study (EPIDS).
Brown, KA; Haber, SB; Heller, GV; Landin, RJ, 1997
)
0.3
" In conclusion, MIBI-SPECT during adenosine stress is a safe diagnostic method that can be performed in most patients early on after thrombolytically treated acute myocardial infarction."( Myocardial perfusion scintigraphy (SPECT) during adenosine stress can be performed safely early on after thrombolytic therapy in acute myocardial infarction.
Bouvier, F; Höjer, J; Hulting, J; Jensen-Urstad, M; Ruiz, H; Samad, B, 1998
)
0.3
" No adverse event was observed except for one case of transient hypotension caused by the exercise."( [Evaluation of the safety and clinical feasibility of exercise 99mTc-MIBI SPECT using one day protocol--multicenter phase III clinical trial report].
Hashimoto, J; Imai, K; Kobayashi, H; Kubo, A; Kusakabe, K; Nakajima, K; Tanaka, T; Tonami, N, 1998
)
0.3
" No serious adverse events or deaths occurred."( NC100100, a new echo contrast agent for the assessment of myocardial perfusion--safety and comparison with technetium-99m sestamibi single-photon emission computed tomography in a randomized multicenter study.
Assayag, P; Baer, F; Binder, T; Flachskampf, F; Kamp, O; Lindvall, K; Marelli, C; Meland, N; Nienaber, C; Nihoyannopoulos, P; Piérard, L; Steg, G; Van der Wouw, P; Vanoverschelde, JL, 1999
)
0.3
"NC100100 is safe in patients with myocardial infarction."( NC100100, a new echo contrast agent for the assessment of myocardial perfusion--safety and comparison with technetium-99m sestamibi single-photon emission computed tomography in a randomized multicenter study.
Assayag, P; Baer, F; Binder, T; Flachskampf, F; Kamp, O; Lindvall, K; Marelli, C; Meland, N; Nienaber, C; Nihoyannopoulos, P; Piérard, L; Steg, G; Van der Wouw, P; Vanoverschelde, JL, 1999
)
0.3
" Adverse reaction data were collected on all patients and compared by sex."( Treadmill exercise during adenosine infusion is safe, results in fewer adverse reactions, and improves myocardial perfusion image quality.
Fabrizi, RR; Hayashida, C; Kothapalli, S; Majmundar, H; Miyamoto, MI; Payne, JL; Payne, MM; Prill, NV; Thomas, GS; Thomas, JJ,
)
0.13
" Hypotensive and arrhythmic (atrioventricular block, sinus bradycardia, and new onset atrial fibrillation or flutter) adverse reactions occurred less often during adenosine-exercise than during adenosine-nonexercise."( Treadmill exercise during adenosine infusion is safe, results in fewer adverse reactions, and improves myocardial perfusion image quality.
Fabrizi, RR; Hayashida, C; Kothapalli, S; Majmundar, H; Miyamoto, MI; Payne, JL; Payne, MM; Prill, NV; Thomas, GS; Thomas, JJ,
)
0.13
" Women were more likely to experience adverse reactions than men."( Treadmill exercise during adenosine infusion is safe, results in fewer adverse reactions, and improves myocardial perfusion image quality.
Fabrizi, RR; Hayashida, C; Kothapalli, S; Majmundar, H; Miyamoto, MI; Payne, JL; Payne, MM; Prill, NV; Thomas, GS; Thomas, JJ,
)
0.13
"Limited data are available about the effects of adjunctive treadmill exercise on adverse effects and the image quality of adenosine perfusion imaging."( Impact of an abbreviated adenosine protocol incorporating adjunctive treadmill exercise on adverse effects and image quality in patients undergoing stress myocardial perfusion imaging.
Elliott, MD; Hendel, RC; Holly, TA; Leonard, SM,
)
0.13
" More adverse effects were experienced during the standard adenosine study than during the adenosine study with low-level exercise (2."( Impact of an abbreviated adenosine protocol incorporating adjunctive treadmill exercise on adverse effects and image quality in patients undergoing stress myocardial perfusion imaging.
Elliott, MD; Hendel, RC; Holly, TA; Leonard, SM,
)
0.13
"In comparison with standard 6-minute adenosine perfusion imaging, a protocol incorporating a 4-minute adenosine infusion with low-level treadmill exercise results in a marked reduction in the quantity and severity of adverse effects and an improvement in image quality."( Impact of an abbreviated adenosine protocol incorporating adjunctive treadmill exercise on adverse effects and image quality in patients undergoing stress myocardial perfusion imaging.
Elliott, MD; Hendel, RC; Holly, TA; Leonard, SM,
)
0.13
" Adverse events during infusion of the adenosine were seen in 42 (64%) patients and included chest discomfort/oppression in 17 (26%) and dyspnea/throat discomfort in 15 (23%)."( [Safety of adenosine stress myocardial perfusion imaging by a one-route infusion protocol].
Kawai, Y; Kishino, K, 2006
)
0.33
" However, the protocol recommended for Dob-MPS is long and frequently associated with adverse effects."( Reduced adverse effects with an accelerated dobutamine stress protocol compared with the conventional protocol: a prospective, randomized myocardial perfusion scintigraphy study.
De Lorenzo, A; Issa, A; Leão Lima, Rde S, 2008
)
0.35
" We compared age, gender, coronary risk factors, history of MI or revascularization, Dob infusion and total stress times, maximal HR, percentage of maximal predicted HR, rate-pressure product, ST changes, MPS scores and incidence of adverse effects."( Reduced adverse effects with an accelerated dobutamine stress protocol compared with the conventional protocol: a prospective, randomized myocardial perfusion scintigraphy study.
De Lorenzo, A; Issa, A; Leão Lima, Rde S, 2008
)
0.35
"Early administration of atropine makes stress faster and reduces incidence of adverse effects, without reducing efficacy towards achieving the proposed goals."( Reduced adverse effects with an accelerated dobutamine stress protocol compared with the conventional protocol: a prospective, randomized myocardial perfusion scintigraphy study.
De Lorenzo, A; Issa, A; Leão Lima, Rde S, 2008
)
0.35
" We have shown in large mammalian models of chronic myocardial ischemia and acute myocardial infarction that intramyocardial pVEGF165 at doses significantly higher than those used in recent phase II trials is safe and efficacious on myocardial perfusion, left ventricular function, and infarct size limitation."( High-dose plasmid-mediated VEGF gene transfer is safe in patients with severe ischemic heart disease (Genesis-I). A phase I, open-label, two-year follow-up trial.
Bercovich, A; Criscuolo, M; Crottogini, A; Diez, M; Favaloro, L; Garelli, G; Janavel, GV; Mendiz, O; Ratto, R; Salmo, F; Valdivieso, L, 2013
)
0.39
"No serious adverse events related to either VEGF or the injection procedure occurred over the 2-year follow-up."( High-dose plasmid-mediated VEGF gene transfer is safe in patients with severe ischemic heart disease (Genesis-I). A phase I, open-label, two-year follow-up trial.
Bercovich, A; Criscuolo, M; Crottogini, A; Diez, M; Favaloro, L; Garelli, G; Janavel, GV; Mendiz, O; Ratto, R; Salmo, F; Valdivieso, L, 2013
)
0.39
"High-dose intramyocardial pVEGF165 is safe at 2 years follow-up in patients with severe CAD."( High-dose plasmid-mediated VEGF gene transfer is safe in patients with severe ischemic heart disease (Genesis-I). A phase I, open-label, two-year follow-up trial.
Bercovich, A; Criscuolo, M; Crottogini, A; Diez, M; Favaloro, L; Garelli, G; Janavel, GV; Mendiz, O; Ratto, R; Salmo, F; Valdivieso, L, 2013
)
0.39
" Extensive safety assessment revealed that flurpiridaz F 18 was safe in this cohort."( Phase II safety and clinical comparison with single-photon emission computed tomography myocardial perfusion imaging for detection of coronary artery disease: flurpiridaz F 18 positron emission tomography.
Berman, DS; Bhat, G; Czernin, J; Devine, M; Gibson, CM; Lazewatsky, J; Maddahi, J; Taillefer, R; Tamarappoo, BK; Udelson, JE; Washburn, D, 2013
)
0.39
"In this phase 2 trial, PET MPI with flurpiridaz F 18 was safe and superior to SPECT MPI for image quality, interpretative certainty, and overall CAD diagnosis."( Phase II safety and clinical comparison with single-photon emission computed tomography myocardial perfusion imaging for detection of coronary artery disease: flurpiridaz F 18 positron emission tomography.
Berman, DS; Bhat, G; Czernin, J; Devine, M; Gibson, CM; Lazewatsky, J; Maddahi, J; Taillefer, R; Tamarappoo, BK; Udelson, JE; Washburn, D, 2013
)
0.39
" All patients tolerated the radiotracer without serious adverse effects."( A Phase I-II, Open-Label, Multicenter Trial to Determine the Dosimetry and Safety of 99mTc-Sestamibi in Pediatric Subjects.
Azarbar, S; Crane, PD; Dahdah, N; Lazewatsky, J; Lee, ML; Portman, M; Salardini, A; Sparks, R; Zhu, Q, 2015
)
0.42

Pharmacokinetics

ExcerptReferenceRelevance
" When the myocardial septum-to-lateral count ratio is used as an index of distortion, a shorter acquisition time than the effective half-life of the tracer is required to reduce the error of the septum-to-lateral count ratio to within 10%."( A simulation of dynamic SPECT using radiopharmaceuticals with rapid clearance.
Bunko, H; Hisada, K; Ichihara, T; Motomura, N; Nakajima, K; Shuke, N; Taki, J, 1992
)
0.28
" Maximum MIBI activity and activity elimination half-life in the abnormal parathyroid glands and thyroid glands were measured, and the maximum uptake ratio was calculated."( Clinicopathologic and radiopharmacokinetic factors affecting gamma probe-guided parathyroidectomy.
Bozkurt, MF; Etikan, I; Gulec, SA; Hamaloglu, E; Sayek, I; Sokmensuer, C; Ugur, O; Ugur, Y, 2004
)
0.32
" Elimination half-life of MIBI from parathyroid inversely correlated with Pgp (r = -0."( Clinicopathologic and radiopharmacokinetic factors affecting gamma probe-guided parathyroidectomy.
Bozkurt, MF; Etikan, I; Gulec, SA; Hamaloglu, E; Sayek, I; Sokmensuer, C; Ugur, O; Ugur, Y, 2004
)
0.32
" Posterior Bayesian estimates of vinorelbine clearance were obtained for each patient using population pharmacokinetic modeling."( Predictors of vinorelbine pharmacokinetics and pharmacodynamics in patients with cancer.
Ackland, SP; Balleine, RL; Blair, EY; Clarke, CL; Collins, M; Evans, S; Farlow, D; Garg, MB; Gurney, H; Hoskins, JM; Mann, GJ; McLachlan, AJ; Rivory, LP; Wong, M, 2006
)
0.33
"Specific indicators of drug clearance provide predictive information about vinorelbine pharmacokinetics, and body-surface area, probably reflecting normal bone marrow reserve, provides an additional pharmacodynamic indicator."( Predictors of vinorelbine pharmacokinetics and pharmacodynamics in patients with cancer.
Ackland, SP; Balleine, RL; Blair, EY; Clarke, CL; Collins, M; Evans, S; Farlow, D; Garg, MB; Gurney, H; Hoskins, JM; Mann, GJ; McLachlan, AJ; Rivory, LP; Wong, M, 2006
)
0.33
"This pharmacodynamic trial evaluated the effect of CBT-1® on efflux by the ATP binding cassette (ABC) multidrug transporter P-glycoprotein (Pgp/MDR1/ABCB1) in normal human cells and tissues."( A pharmacodynamic study of the P-glycoprotein antagonist CBT-1® in combination with paclitaxel in solid tumors.
Barnett, D; Bates, SE; Caluag, Z; Chen, CC; Draper, D; Fojo, T; Frye, AR; Kelly, RJ; Luchenko, V; Oldham, RK; Robey, RW; Steinberg, SM, 2012
)
0.38
" This pharmacodynamic study demonstrated that CBT-1®, inhibits Pgp-mediated efflux from PBMCs and normal liver."( A pharmacodynamic study of the P-glycoprotein antagonist CBT-1® in combination with paclitaxel in solid tumors.
Barnett, D; Bates, SE; Caluag, Z; Chen, CC; Draper, D; Fojo, T; Frye, AR; Kelly, RJ; Luchenko, V; Oldham, RK; Robey, RW; Steinberg, SM, 2012
)
0.38
" The purpose of this study was to propose a clinically applicable pharmacokinetic model with metabolic equilibrium of (99m)Tc-MIBI and to evaluate the accuracy of the model."( Pharmacokinetic model of myocardial (99m)Tc-sestamibi washout.
Hara, M; Hiraoka, M; Mizowaki, T; Monzen, H; Watanabe, T, 2013
)
0.39
" A population pharmacokinetic model using non-linear mixed-effects modeling software NONMEM was built, which included the phenotype tests as covariate."( Predictive value of CYP3A and ABCB1 phenotyping probes for the pharmacokinetics of sunitinib: the ClearSun study.
Balakrishnar, B; Bennink, RJ; Daali, Y; Eechoute, K; Gurney, H; Huitema, AD; Kam, BL; Kloth, JS; Klümpen, HJ; Mathijssen, RH; Samer, CF; Schellens, JH; Wong, M; Yu, H; Zwinderman, AH, 2014
)
0.4
" This case highlights the possible pharmacokinetic interaction between phenytoin intake and Tc-sestamibi, resulting in faster hepatic clearance of the radiotracer."( Phenytoin Could Potentially Increase Hepatic Clearance of 99mTc-Sestamibi in Myocardial Perfusion Imaging.
Kavanal, AJ; Mittal, BR; Parmar, M; Singh, D; Sood, A, 2018
)
0.48

Compound-Compound Interactions

ExcerptReferenceRelevance
"Forty-two patients with known stable coronary artery disease, referred for coronary angiography, were examined with technetium-99m-hexakis-2-methoxy-2-methylpropyl-isonitrile (MIBI) tomography combined with a high-dose dipyridamole infusion (0."( Usefulness of technetium-99m-MIBI and thallium-201 in tomographic imaging combined with high-dose dipyridamole and handgrip exercise for detecting coronary artery disease.
Heikkilä, J; Huikuri, HV; Kettunen, R; Takkunen, JT, 1991
)
0.28
"Dobutamine stress combined with echocardiography or perfusion scintigraphy may be used to detect coronary artery disease."( Optimal use of dobutamine stress for the detection and evaluation of coronary artery disease: combination with echocardiography or scintigraphy, or both?
Baudhuin, T; D'Hondt, AM; Detry, JM; Marwick, T; Melin, J; Wijns, W; Willemart, B, 1993
)
0.29
"Intravenously administered adenosine and high-dose dipyridamole, both combined with low-level exercise stress, were compared in a head-to-head fashion using 99Tcm-methoxyisobutyl isonitrile (99Tcm-MIBI) single photo emission tomography (SPET) myocardial perfusion imaging."( Comparison of adenosine and high-dose dipyridamole both combined with low-level exercise stress for 99Tcm-MIBI SPET myocardial perfusion imaging.
Ascoop, CA; Cramer, MJ; Niemeyer, MG; Pauwels, EK; van der Wall, EE; Vermeersch, PH; Verzijlbergen, JF; Zwinderman, AH, 1996
)
0.29
"The aim of this study was to define the clinical impact of MIBI scan combined with neck ultrasonography on the detection of metastates in differentiated thyroid carcinoma (DTC) patients with elevated serum Tg levels but negative 131I scan (non-functioning DTC)."( Clinical approach in patients with metastatic differentiated thyroid carcinoma and negative 131I whole body scintigraphy: importance of 99mTc MIBI scan combined with high resolution neck ultrasonography.
Casara, D; Mazzarotto, R; Pelizzo, MR; Rubello, D; Saladini, G; Sotti, G; Tomasella, G,
)
0.13
"On the basis of these data, MIBI scan combined with neck US could be proposed as a first-line diagnostic imaging modality in the follow-up of DTC patients with elevated serum Tg levels and negative 131I scan."( Clinical approach in patients with metastatic differentiated thyroid carcinoma and negative 131I whole body scintigraphy: importance of 99mTc MIBI scan combined with high resolution neck ultrasonography.
Casara, D; Mazzarotto, R; Pelizzo, MR; Rubello, D; Saladini, G; Sotti, G; Tomasella, G,
)
0.13
"A retrospective review of 54 cases of primary hyperparathyroidism operated upon by five general surgeons at Santa Barbara Cottage Hospital between March 1998 and March 2001 was performed to determine whether positive preoperative sestamibi localization (PSL) of a solitary adenoma combined with intraoperative parathyroid hormone assay (IOPHA) could predict successful focused unilateral neck exploration."( Preoperative sestamibi localization combined with intraoperative parathyroid hormone assay predicts successful focused unilateral neck exploration during surgery for primary hyperparathyroidism.
Davidson, D; Dunn, J; Kindred, A; Kosoy, D; Lang, H; Latimer, RG; Miller, P; Waxman, K, 2003
)
0.32
" ultrasonography (US) of the neck combined with rapid intact parathyroid hormone (iPTH) assay in US-guided fine-needle parathyroid aspirates in preoperative localization of parathyroid adenomas and in directing surgical approach."( Technetium-99m-sestamibi subtraction scintigraphy vs. ultrasonography combined with a rapid parathyroid hormone assay in parathyroid aspirates in preoperative localization of parathyroid adenomas and in directing surgical approach.
Barczynski, M; Buziak-Bereza, M; Cichon, S; Golkowski, F; Hubalewska-Dydejczyk, A; Huszno, B; Konturek, A; Szybinski, Z, 2006
)
0.33
"The results of SS for localization of parathyroid adenoma were determined in 121 patients with primary hyperparathyroidism (pHPT) and compared with findings at surgery and with the results of US alone (in patients without nodular goitre) and US in combination with the iPTH assay in US-guided fine-needle aspirates (FNAs) of suspicious parathyroid lesions (in patients with concomitant nodular goitre)."( Technetium-99m-sestamibi subtraction scintigraphy vs. ultrasonography combined with a rapid parathyroid hormone assay in parathyroid aspirates in preoperative localization of parathyroid adenomas and in directing surgical approach.
Barczynski, M; Buziak-Bereza, M; Cichon, S; Golkowski, F; Hubalewska-Dydejczyk, A; Huszno, B; Konturek, A; Szybinski, Z, 2006
)
0.33
" High-resolution US of the neck was performed by a single endocrine surgeon and combined with US-guided FNAs of suspicious parathyroid lesions in all patients with nodular goitre (n = 43)."( Technetium-99m-sestamibi subtraction scintigraphy vs. ultrasonography combined with a rapid parathyroid hormone assay in parathyroid aspirates in preoperative localization of parathyroid adenomas and in directing surgical approach.
Barczynski, M; Buziak-Bereza, M; Cichon, S; Golkowski, F; Hubalewska-Dydejczyk, A; Huszno, B; Konturek, A; Szybinski, Z, 2006
)
0.33
"MIBI accuracy in patients with secondary hyperparathyroidism was increased when combined with other preoperative parameters."( Tc-99m sestamibi accuracy in detecting parathyroid tissue is increased when combined with preoperative laboratory values: a retrospective study in 453 Greek patients with chronic renal failure who underwent parathyroidectomy.
Antoniadis, N; Arsos, G; Fouzas, I; Gakis, D; Giakoustidis, D; Imvrios, G; Kardasis, D; Ntinas, A; Ouzounidis, N; Papagiannis, A; Papanikolaou, V; Takoudas, D; Vrochides, D, 2008
)
0.35
" Combined with its ease of administration and lack of toxicity, the data showing inhibition of normal tissue Pgp support further studies with CBT-1® to evaluate its ability to modulate drug uptake in tumor tissue."( A pharmacodynamic study of the P-glycoprotein antagonist CBT-1® in combination with paclitaxel in solid tumors.
Barnett, D; Bates, SE; Caluag, Z; Chen, CC; Draper, D; Fojo, T; Frye, AR; Kelly, RJ; Luchenko, V; Oldham, RK; Robey, RW; Steinberg, SM, 2012
)
0.38

Bioavailability

ExcerptReferenceRelevance
" One way of prolonging the bioavailability of 99Tcm-MIBI is to use liposomes which do not affect its accumulation in tumour cells."( Uptake of liposome-encapsulated 99Tcm-MIBI by sensitive and multidrug-resistant tumour cell lines.
Benazzouz, F; Cordobes, MD; de Beco, V; Moretti, JL; Starzec, A, 1999
)
0.3
" Furthermore, the protective function of Pgp-mediated efflux of xenobiotics in various organs has a profound effect on the bioavailability of drugs in general."( Characterization of a novel 99mTc-carbonyl complex as a functional probe of MDR1 P-glycoprotein transport activity.
Blake, HM; Dahlheimer, JL; Dyszlewski, M; Pica, CM; Piwnica-Worms, D,
)
0.13
" Variations in the mdr1 gene product may directly affect the therapeutic effectiveness, and single nucleotide polymorphisms for the mdr1 gene may be associated with altered oral bioavailability of MDR1 substrates, drug resistance, and a susceptibility to some human diseases."( Imaging of multidrug resistance in cancer.
Dizdarevic, S; Peters, AM, 2011
)
0.37

Dosage Studied

ExcerptRelevanceReference
"The test was completed on 21 of the 22 patients, and 20 of the latter were subjected to the maximal dosage of the adenosine infusion."( [The adenosine test in association with 99m-technetium sestamibi tomoscintigraphy in the diagnosis of coronary pathology].
Bettini, D; Braito, E; Crepaz, R; Osele, L; Pitscheider, W; Romeo, C; Zammarchi, A, 1992
)
0.28
"To determine the safety of three different dosage regimens of intravenous adenosine."( Safety of different dosages of intravenous adenosine used in conjunction with diagnostic myocardial imaging techniques.
Esterbrooks, DJ; Gupta, NC; Hilleman, DE; Mohiuddin, SM,
)
0.13
"Subjects underwent myocardial perfusion imaging in conjunction with one of three intravenous dosage regimens: 1 = fixed dosage 140 micrograms/kg/minute for 6 minutes; 2 = dosage titration to a maximum of 140 micrograms/kg/minute; and 3 = dosage titration to a maximum of 200 micrograms/kg/minute."( Safety of different dosages of intravenous adenosine used in conjunction with diagnostic myocardial imaging techniques.
Esterbrooks, DJ; Gupta, NC; Hilleman, DE; Mohiuddin, SM,
)
0.13
" Modulator dose-response curves were generated for PSC833, cyclosporin A, and verapamil."( Technetium-99m-tetrofosmin as a substrate for P-glycoprotein: in vitro studies in multidrug-resistant breast tumor cells.
Ballinger, JR; Bannerman, J; Boxen, I; Firby, P; Hartman, NG; Moore, MJ, 1996
)
0.29
" Dose-response curves were generated for two modulators of Pgp function, GG918 and PSC833."( In vitro comparison of sestamibi, tetrofosmin, and furifosmin as agents for functional imaging of multidrug resistance in tumors.
Ballinger, JR; Moore, MJ; Muzzammil, T, 2000
)
0.31
" Potential variation among patients in organ activity was reduced with a weight-based dosing protocol."( Increased extra-cardiac background uptake on immediate and delayed post-stress images with 99Tcm sestamibi: determinants, independence, and significance of counts in lung, abdomen and myocardium.
Hurwitz, GA, 2000
)
0.31
" The uptake of 99mTc-MIBI in each dosage group was determined before and 24, 48, 72 h after irradiation respectively."( Monitoring of biological responses of tumor cells after irradiation with 99mTc-MIBI--an in vitro study.
Wu, H; Xia, J; Xianyu, Z; Zhao, M, 2001
)
0.31
" Furthermore, it is uncertain whether there exists a TMR dose-response relationship that is a function of channel number."( Transmyocardial laser revascularization dose response: enhanced perfusion in a porcine ischemia model as a function of channel density.
Hamawy, AH; Lee, LY; Polce, DR; Rosengart, TK; Samy, SA; Szulc, M; Vazquez, M, 2001
)
0.31
" A dose-response relationship related to channel number may be of significance when evaluating the efficacy of various treatment strategies."( Transmyocardial laser revascularization dose response: enhanced perfusion in a porcine ischemia model as a function of channel density.
Hamawy, AH; Lee, LY; Polce, DR; Rosengart, TK; Samy, SA; Szulc, M; Vazquez, M, 2001
)
0.31
"Plasmid DNA encoding for the 165- and 167-amino acid isoform of the human VEGF genes was injected directly into the myocardium, not amenable to surgical revascularization at a dosage of 1000 microg each, using a standardized protocol."( Simultaneous surgical revascularization and angiogenic gene therapy in diffuse coronary artery disease.
Greilach, P; Huwer, H; Isringhaus, H; Kalweit, G; Ozbek, C; Seifert, M; Straub, U; Welter, C, 2001
)
0.31
"Marked interindividual variation in drug disposition and toxicity pose an ongoing challenge to chemotherapy dosage individualization."( Predictors of vinorelbine pharmacokinetics and pharmacodynamics in patients with cancer.
Ackland, SP; Balleine, RL; Blair, EY; Clarke, CL; Collins, M; Evans, S; Farlow, D; Garg, MB; Gurney, H; Hoskins, JM; Mann, GJ; McLachlan, AJ; Rivory, LP; Wong, M, 2006
)
0.33
"The marked variability of irinotecan (Ir) clearance warrants individualized dosing based on hepatic drug handling."( Relationship of hepatic functional imaging to irinotecan pharmacokinetics and genetic parameters of drug elimination.
Clarke, SJ; Di Iulio, J; Ellis, A; Foo, K; Gurtler, V; Hicks, RJ; Hoskins, JM; Jefford, M; Michael, M; Milner, AD; Mitchell, PL; Scott, AM; Tebbut, NC; Thompson, M; Zalcberg, JR, 2006
)
0.33
" A2780/Adr xenograft mice were dosed with mdr1 antisense oligodeoxynucleotides intratumorally for three days; next, mice were treated with WK-X-34, followed by (99m)Tc-sestamibi injection."( 99mTc-Sestamibi, a sensitive probe for in vivo imaging of P-glycoprotein inhibition by modulators and mdr1 antisense oligodeoxynucleotides.
Jekerle, V; Piquette-Miller, M; Reilly, RM; Scollard, DA; Wang, JH; Wiese, M,
)
0.13
" The injected dosage for 99mTc-methoxyisobutylisonitrile resting and dipyridamole stress imaging is 185 and 555 MBq, respectively, with an interval of about 2 h between the two injections."( Diagnostic efficacy of a low-dose 32-projection SPECT 99mTc-sestamibi myocardial perfusion imaging protocol in routine practice.
Chin, KC; Chiu, NT; Lin, KH; Wu, MC, 2009
)
0.35
" Today, the tendency to minimally invasive surgery, an accurate preoperative localization of the adenoma and the use of techniques such as intra-surgical nuclear mapping through manual gamma probes, selective angiography, venous intraoperative dosage of PTH and intra-surgical ultrasound scan."( Giant mediastinal parathyroid adenoma: a case report.
Cannizzaro, MA; Chisari, A; Costanzo, M; Marziani, A; Missiato, A; Terminella, A,
)
0.13
" We elaborated a dose-response model by statistical analysis based on linear mixed models."( 99mTc-sestamibi scintigraphy to monitor the long-term efficacy of enzyme replacement therapy on bone marrow infiltration in patients with Gaucher disease.
Brady, RO; Buffoni, F; Dambrosia, J; Di Rocco, M; Erba, PA; Filocamo, M; Giona, F; Linari, S; Mariani, G; Minichilli, F; Pierini, A, 2013
)
0.39
"Although based on localized evaluation, changes in the (99m)Tc-sestamibi score closely correlated with the main determinants of ERT, with a definite dose-response relationship."( 99mTc-sestamibi scintigraphy to monitor the long-term efficacy of enzyme replacement therapy on bone marrow infiltration in patients with Gaucher disease.
Brady, RO; Buffoni, F; Dambrosia, J; Di Rocco, M; Erba, PA; Filocamo, M; Giona, F; Linari, S; Mariani, G; Minichilli, F; Pierini, A, 2013
)
0.39
" To provide clinicians with evidence-based dosage recommendation, a phase I-II, open-label, nonrandomized, multicenter trial was therefore designed using (99m)Tc-sestamibi in pediatric subjects (registered under www."( A Phase I-II, Open-Label, Multicenter Trial to Determine the Dosimetry and Safety of 99mTc-Sestamibi in Pediatric Subjects.
Azarbar, S; Crane, PD; Dahdah, N; Lazewatsky, J; Lee, ML; Portman, M; Salardini, A; Sparks, R; Zhu, Q, 2015
)
0.42
" As such, applying current (99m)Tc-sestamibi dosing regimens for 1- and 2-d protocols based on those extrapolations will result in the expected radiation dose in children and adolescents."( A Phase I-II, Open-Label, Multicenter Trial to Determine the Dosimetry and Safety of 99mTc-Sestamibi in Pediatric Subjects.
Azarbar, S; Crane, PD; Dahdah, N; Lazewatsky, J; Lee, ML; Portman, M; Salardini, A; Sparks, R; Zhu, Q, 2015
)
0.42
" Intraoperative parathormone dosage is fundamental to guide the endocrine surgeon and to verify the completeness of surgical resection."( Preoperative localization of parathyroid adenoma in video-assisted era: is cervical ultrasound or 99mTc Sesta MIBI scintigraphy better?
Bendinelli, C; Catena, F; DE Simone, B; Del Rio, P; Fallani, G; Napoli, JA; Sianesi, M; Zaccaroni, A, 2017
)
0.46
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (5,161)

TimeframeStudies, This Drug (%)All Drugs %
pre-199051 (0.99)18.7374
1990's1812 (35.11)18.2507
2000's1954 (37.86)29.6817
2010's1038 (20.11)24.3611
2020's306 (5.93)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials627 (10.86%)5.53%
Reviews369 (6.39%)6.00%
Case Studies995 (17.23%)4.05%
Observational23 (0.40%)0.25%
Other3,760 (65.12%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (26)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Evaluation of 99mTc Sestamibi Scans In Patients Who Have Differentiated Thyroid Cancer, Elevated Serum Thyroglobulin Levels, and Negative Diagnostic Imaging Studies [NCT03065218]Phase 44 participants (Actual)Interventional2016-10-31Terminated(stopped due to Insufficient recruitment)
A Phase 3, Open Label, Multicenter Study for the Assessment of Myocardial Perfusion Using Positron Emission Tomography (PET) Imaging of Flurpiridaz F18 Injection in Patients With Suspected or Known Coronary Artery Disease (CAD) [NCT01347710]Phase 3795 participants (Actual)Interventional2011-06-30Completed
xSPECT-based Myocardial Perfusion Scintigraphy: Consistency of Functional Values and Feasibility of Myocardial Uptake Quantitation in Patients With Suspected Coronary Artery Disease (xSPECT MPI Study) [NCT04583787]50 participants (Anticipated)Interventional2021-12-07Recruiting
A Phase III, Open-Label, Non-Randomized, International, Multicenter Trial to Evaluate the Efficacy and Safety of CARDIOLITE® Myocardial Perfusion Imaging in Pediatric Subjects With Kawasaki Disease [NCT00162032]Phase 3445 participants (Actual)Interventional2005-08-31Completed
Pilot Clinical Study to Evaluate Molecular Breast Imaging- Guidance for Sampling of Breast Abnormalities [NCT06058650]70 participants (Anticipated)Interventional2021-08-26Recruiting
Study of 99mTc-Sestamibi SPECT/CT Imaging for the Preoperative Diagnosis of Renal Oncocytoma [NCT02160925]125 participants (Actual)Interventional2014-05-31Completed
Evaluation of Low-dose Molecular Breast Imaging as a Screening Tool in Women With Mammographically Dense Breasts and Increased Risk of Breast Cancer [NCT00620373]969 participants (Actual)Interventional2005-08-31Completed
Regadenoson Blood Flow in Type 1 Diabetes (RABIT1D) [NCT01019486]Phase 426 participants (Actual)Interventional2009-11-30Completed
SPECT/CT for the Characterization of Renal Masses: Impact on Clinical Decision Making [NCT03996850]100 participants (Anticipated)Observational2018-12-07Recruiting
A Phase 2, Open-Label, Randomized, Cross-Over Study of Regadenoson in Subjects Undergoing Stress Myocardial Perfusion Imaging by Multidetector Computed Tomography (MDCT) and Single Photon Emission Computed Tomography (SPECT) [NCT01334918]Phase 2124 participants (Actual)Interventional2011-04-26Completed
Study of the Concordance Between a Traditional Protocol of Stress and Rest Myocardial Tomoscintigraphy Using 99mTc-sestamibi and a Double Isotope Protocol Using Thallium-201 and 99mTc-sestamibi, With a Semiconductor Camera [NCT02869126]118 participants (Actual)Interventional2012-09-30Completed
AceP-D: Non-invasive Assessment of Atypical Chest Pain in Patients With Diabetes [NCT00162344]Phase 4205 participants (Actual)Interventional2003-12-31Completed
A Phase I-II, Open-Label, Multicenter Trial to Determine the Dosimetry and Safety of Technetium Tc99m Sestamibi in Pediatric Subjects [NCT00162045]Phase 1/Phase 279 participants (Actual)Interventional2005-01-31Completed
18F-Fluorocholine PET/CT in the Pre-operative Localization of Hyperfunctional Parathyroid Gland in Primary and Secondary Hyperparathyroidism [NCT04316845]38 participants (Actual)Interventional2018-01-16Completed
Cardiolite-406; A Phase IV Open-Label, Randomized, Multi-Center Trial To Evaluate The Ability of Cardiolite Stress MPI to Detect Asymptomatic Restenosis in Diabetic Patients Who Have Undergone Percutaneous Coronary Intervention [NCT00162357]Phase 4106 participants (Actual)Interventional2004-04-30Completed
Density MATTERS [Molecular Breast Imaging (MBI) And Tomosynthesis To Eliminate the ReServoir] [NCT03220893]1,732 participants (Actual)Interventional2017-06-14Active, not recruiting
Assessment of the Tumor Response to Neoadjuvant Chemotherapy in Women With Locoregional Invasive Breast Cancer Using Tc99m Sestamibi Molecular Breast Imaging: A Prospective Study [NCT02324387]96 participants (Actual)Interventional2015-06-15Active, not recruiting
AIR-MI: Assessment of Ischemia and Remodeling Following Acute Myocardial Infarction [NCT00162331]Phase 474 participants (Actual)Interventional2005-01-31Completed
Multimodality Breast Imaging for the Assessment of Tumor Response to Neoadjuvant Chemotherapy in Triple Negative Breast Cancer Patients [NCT02744053]Early Phase 196 participants (Actual)Interventional2016-11-07Active, not recruiting
Comparative Performance of Molecular Breast Imaging (MBI) to Magnetic Resonance Imaging (MRI) of the Breast in Identifying and Excluding Breast Carcinoma in Women at High Risk for Breast Cancer [NCT05042687]300 participants (Anticipated)Interventional2021-12-13Recruiting
Feasibility of Half-Dose Radiopharmaceutical Administration Utilizing Wide-Beam Reconstruction [NCT01499654]64 participants (Actual)Interventional2011-10-31Terminated(stopped due to Low enrollment)
A Pharmacodynamic Study of the P-glycoprotein (Pgp) Antagonist, CBT-1(Registered Trademark), Evaluating Pgp Inhibition in Tumors and Normal Tissues [NCT00972205]12 participants (Actual)Interventional2007-12-31Completed
A Prospective, Open-label, Multicenter Study With Blinded Over-reading Characterizing the Efficacy and Safety of 99mTc-EC-DG in the Evaluation of Coronary Artery Disease (CAD) [NCT01899833]Phase 260 participants (Anticipated)Interventional2021-01-10Active, not recruiting
The Combination of Radiotherapy With the Anti-Angiogenic Agent Tetrathiomolybdate (TM) in the Treatment of Stage I-IIIB Non-Small Cell Lung Cancer (NSCLC): A Phase I Study [NCT00560495]Phase 10 participants (Actual)Interventional2007-05-31Withdrawn
A Clinical Trial of the P-Glycoprotein Antagonist, Tariquidar (XR9576), in Combination With Docetaxel in Patients With Lung, Ovarian, Renal and Cervical Cancer: Analysis of the Interaction Between Tariquidar and Docetaxel [NCT00069160]Phase 248 participants (Actual)Interventional2003-09-30Completed
Evaluation of Low-dose Molecular Breast Imaging as a Screening Tool in Women With Mammographically Dense Breasts and Increased Risk of Breast Cancer [NCT01925170]1,638 participants (Actual)Interventional2009-04-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00069160 (6) [back to overview]Geometric Mean of Maximum Concentration of the Drug (Cmax)
NCT00069160 (6) [back to overview]The Number of Participants With Adverse Events.
NCT00069160 (6) [back to overview]Percent Increase in Sestamibi Area Under Curve (AUC) in Tumor Tissue
NCT00069160 (6) [back to overview]Percent Increase in Sestamibi Area Under Curve (AUC) in Liver After Tariquidar
NCT00069160 (6) [back to overview]Clinical Response Rate
NCT00069160 (6) [back to overview]Geometric Mean of Area Under Curve (AUC0)-24
NCT00162032 (5) [back to overview]Determine the Predictive Value of Cardiolite® Rest and Stress MPI to Define Pediatric Populations With Kawasaki Disease at High and Low Risk of Developing Cardiac Events.
NCT00162032 (5) [back to overview]Incidence of Hard Cardiac Events
NCT00162032 (5) [back to overview]Predictive Value of Cardiolite For Cardiac Events
NCT00162032 (5) [back to overview]Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in Adolescents and Children Versus Coronary Angiography
NCT00162032 (5) [back to overview]Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in the Left Anterior Descending (LAD) Artery in Adolescents and Children Versus Coronary Angiography
NCT00620373 (5) [back to overview]Diagnostic Yield
NCT00620373 (5) [back to overview]Recall Rate
NCT00620373 (5) [back to overview]Specificity
NCT00620373 (5) [back to overview]Number of Participants With Cancer Diagnosis at 12 Months
NCT00620373 (5) [back to overview]Sensitivity
NCT00972205 (4) [back to overview]Percent Increase in Sestamibi Retention in the Liver as a Measure of P-glycoprotein Inhibition
NCT00972205 (4) [back to overview]Percent Inhibition of Rhodamine Efflux From CD56+Cells Post Treatment
NCT00972205 (4) [back to overview]Number of Participants With Adverse Events
NCT00972205 (4) [back to overview]Number of Participants Who Had an Overall Response
NCT01019486 (3) [back to overview]Coronary Blood Flow Assessment With Regadenoson Stress by Cardiac MRI Between Non-diabetic and Type 1 Diabetic Subjects.
NCT01019486 (3) [back to overview]Measured Coronary Blood Flow is Directly Correlated With Coronary Flow Reserve Measured Invasively in the Cardiac Catheterization Laboratory After Regadenoson Pharmacologic Stress.
NCT01019486 (3) [back to overview]Myocardial Perfusion Index
NCT01334918 (7) [back to overview]Number of Participants With Reversible Defects in the Left Circumflex Coronary Artery (LCX)
NCT01334918 (7) [back to overview]Number of Participants With Reversible Defects in the Right Coronary Artery (RCA)
NCT01334918 (7) [back to overview]Overall Image Quality of Scans by Modality and Reviewer
NCT01334918 (7) [back to overview]Percentage of Participants With Two or More Ischemic Segments on SPECT, But Less on CT
NCT01334918 (7) [back to overview]Number of Participants With Fixed Defects
NCT01334918 (7) [back to overview]Number of Participants With Reversible Defects
NCT01334918 (7) [back to overview]Number of Participants With Reversible Defects in the Left Anterior Descending Coronary Artery (LAD)
NCT01347710 (12) [back to overview]Diagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.
NCT01347710 (12) [back to overview]Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).
NCT01347710 (12) [back to overview]Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).
NCT01347710 (12) [back to overview]Overall Summary of Sensitivity of PET MPI vs SPECT MPI; Image Quality Excellent or Good
NCT01347710 (12) [back to overview]Image Quality of Rest and Stress (PET vs SPECT).
NCT01347710 (12) [back to overview]Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT).
NCT01347710 (12) [back to overview]Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT).
NCT01347710 (12) [back to overview]Diagnostic Efficacy of Flurpiridaz PET MPI Specificity Versus SPECT MPI Specificity
NCT01347710 (12) [back to overview]Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.
NCT01347710 (12) [back to overview]Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity
NCT01347710 (12) [back to overview]Overall Summary of Specificity of PET MPI vs SPECT MPI; Image Quality of Excellent or Good
NCT01347710 (12) [back to overview]Diagnostic Certainty in PET MPI and SPECT MPI
NCT01499654 (6) [back to overview]Diagnostic Confidence Score
NCT01499654 (6) [back to overview]Image Quality Score
NCT01499654 (6) [back to overview]Injection and Scan Times
NCT01499654 (6) [back to overview]Resting Full-Tracer Dose
NCT01499654 (6) [back to overview]Segments With Resting Perfusion Defect
NCT01499654 (6) [back to overview]Sum Rest Score
NCT01925170 (5) [back to overview]Biopsy Rate
NCT01925170 (5) [back to overview]Recall Rate
NCT01925170 (5) [back to overview]Sensitivity for All Cancers Diagnosed
NCT01925170 (5) [back to overview]Specificity
NCT01925170 (5) [back to overview]Cancer Detection Rate Per 1000 Women Screened, by Breast Density
NCT03065218 (1) [back to overview]Lesion Detection on 99mTc Sestamibi Study

Geometric Mean of Maximum Concentration of the Drug (Cmax)

In the first cycle patients were to receive docetaxel on days 1 and 8 and to be randomized to receive tariquidar on either day 1 or 8. Thus pharmacokinetic data with and without tariquidar can be compared. (NCT00069160)
Timeframe: 24 hours

,
InterventionCmax (ng/mL) (Geometric Mean)
C1D1C1D8Both Groups (C1D1 + C1D8)
Docetaxel Alone131510601190
With Tariquidar109310261063

[back to top]

The Number of Participants With Adverse Events.

Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module. (NCT00069160)
Timeframe: 4 yrs 8-11 months

Interventionparticipants (Number)
Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 2223
Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 2225

[back to top]

Percent Increase in Sestamibi Area Under Curve (AUC) in Tumor Tissue

99mTc-sestamibi is a radionuclide imaging agent used to study cardiac function that has also been shown to be a substrate for P-glycoprotein- mediated drug efflux. Because of the high expression of Pgp in liver tissue, sestamibi uptake in liver tissue is often monitored as a marker of Pgp inhibition. A significant change in the area under the curve(AUC) in liver tissue (normal tissue as a surrogate) is defined as P<0.001. (NCT00069160)
Timeframe: 3-24 hours

InterventionPercent (Median)
All Patients Who Received Docetaxel and Tariquidar12.4

[back to top]

Percent Increase in Sestamibi Area Under Curve (AUC) in Liver After Tariquidar

A significant change in the area under the curve(AUC) in liver tissue (normal tissue as a surrogate) is defined as P<0.001. A secondary objective of this study was to establish whether tariquidar (150 mg) modulates Pgp in liver. Sestamibi is a Pgp substrate that may be a surrogate for measuring drug efflux from tumors. A baseline Tc-sestamibi scan was obtained before the administration of tariquidar. A minimum of 48 hours later, on or about day 22 a single dose of tariquidar was administered, followed by a second Tc-sestamibi scan. (NCT00069160)
Timeframe: 3 - 24 hours

Interventionpercent increase in sestamibi AUC (Median)
All Patients Who Received Docetaxel and Tariquidar82.2

[back to top]

Clinical Response Rate

Response is determined by RECIST criteria defined as changes in only the largest diameter (unidimensional measurement) of the tumor lesion. Lesions are either measurable or non-measurable. Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as >/- 20 mm with conventional techniques (CT, MRI, xray) or as >/- 10 mm with a spiral CT scan. Non-measurable lesions are defined as all other lesions (or sites of disease) including small lesions (longest diameter <20 mm with conventional techniques or <10 mm using spiral CT. (NCT00069160)
Timeframe: 4 years, 8-11 months

InterventionPercentage of participants (Number)
All Patients Who Received Docetaxel and Tariquidar8

[back to top]

Geometric Mean of Area Under Curve (AUC0)-24

(NCT00069160)
Timeframe: 24 hours

,
Interventionh*ng/mL (Geometric Mean)
C1D1C1D8Both Groups (C1D1 + C1D8)
Docetaxel Alone136713081339
With Tariquidar140913271373

[back to top]

Determine the Predictive Value of Cardiolite® Rest and Stress MPI to Define Pediatric Populations With Kawasaki Disease at High and Low Risk of Developing Cardiac Events.

The proportion of all patients who experienced cardiac events among patients with abnormal (SSS >=4, high risk) and normal (SSS <4, low risk) Cardiolite MPI scans during the follow-up period. A log-rank statistic (2-sided, alpha = 0.05) was computed to compare cardiac event-free survival in the high risk and low risk groups. The cardiac event rate is the cumulative event rate based on a Kaplan-Meier estimate conditional on the SPECT MPI score result. (NCT00162032)
Timeframe: 3 years

Interventionproportion of participants (Number)
Children (4 -11 Years) Normal0.041
Adolescents (12-16 Years) Normal0.033
Children (4-11 Years) Abnormal0.115
Adolescents (12-16 Years) Abnormal0.233

[back to top]

Incidence of Hard Cardiac Events

Examine the incidence of hard cardiac events (myocardial infarction [MI] or cardiac death) in KD subjects with positive and negative MPI scans. (NCT00162032)
Timeframe: 3 years

Interventionparticipants (Number)
Children (4 -11 Years) Normal0
Adolescents (12-16 Years) Normal0
Children (4-11 Years) Abnormal0
Adolescents (12-16 Years) Abnormal0

[back to top]

Predictive Value of Cardiolite For Cardiac Events

Determine the incidence of cardiac events occurring over a 6 month follow up period in pediatric subjects with normal myocardial perfusion scans. (NCT00162032)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Children (4 -11 Years) Normal3
Adolescents (12-16 Years) Normal1
Children (4-11 Years) Abnormal3
Adolescents (12-16 Years) Abnormal2

[back to top]

Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in Adolescents and Children Versus Coronary Angiography

Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of myocardial perfusion imaging (MPI) for the diagnosis of ischemic heart disease (IHD) relative to coronary angiography. Coronary stenoses of ≥ 50% were classified as disease. SSS > 4 in MPI was classified as positive for IHD. (NCT00162032)
Timeframe: 6 months

Interventionproportion (Number)
SensitivitySpecificityPositive Predictive ValueNegative Predictive Value
Angiography Subjects0.350.620.210.77

[back to top]

Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in the Left Anterior Descending (LAD) Artery in Adolescents and Children Versus Coronary Angiography

Sensitivity, specificity, PPV, and NPV of SDS for myocardial perfusion corresponding to the left anterior descending (LAD) for the diagnosis of IHD in the distribution of the left anterior descending (LAD) artery relative to coronary angiography based diagnosis were determined. Coronary stenoses of ≥ 50% for arteries associated with LAD territories were classified as LAD disease. SDS LAD > 1 was classified as positive for IHD for the LAD distribution. (NCT00162032)
Timeframe: 24 hours

,
Interventionproportion (Number)
SensitivitySpecificityPositive Predictive ValueNegative Predictive Value
Adolescents (Ages 12-16)0.000.740.000.82
Children (Ages 4-11).250.760.140.86

[back to top]

Diagnostic Yield

Diagnostic yield is the likelihood that a test or procedure will provide the information needed to establish a diagnosis. In this case, it is the proportion of women with positive results of a screening test and positive results with the reference standard (verified cancer status). (NCT00620373)
Timeframe: 12 months after mammography and gamma imaging

Interventioncancers per 1000 women screened (Number)
Mammography Only3.2
Gamma Imaging9.6
Both Mammography and Gamma Imaging10.7

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Recall Rate

Recall rate was defined as the percentage of participants recalled for follow-up studies initiated because of abnormal findings with mammography or gamma imaging. (NCT00620373)
Timeframe: 12 months after mammography and gamma imaging

Interventionpercentage of participants (Number)
Mammography Only9
Gamma Imaging8
Both Mammography and Gamma Imaging15

[back to top]

Specificity

Specificity measures the proportion of negatives which are correctly identified as such. (NCT00620373)
Timeframe: 12 month after mammography and gamma imaging

Interventionnumber of true negatives (Number)
Mammography Only840
Gamma Imaging861
Both Mammography and Gamma Imaging788

[back to top]

Number of Participants With Cancer Diagnosis at 12 Months

(NCT00620373)
Timeframe: 12 months after mammography and gamma imaging

Interventionparticipants (Number)
Invasive cancerDuctal carcinoma in situ (DCIS)
Mammography and Molecular Breast Imaging74

[back to top]

Sensitivity

Sensitivity measures the proportion of actual positives which are correctly identified as such. (NCT00620373)
Timeframe: 12 months after mammography and gamma imaging

,,
Interventionnumber of cancers diagnosed (Number)
All cancersInvasive cancersDuctal carcinoma in situ (DCIS)
Both Mammography and Gamma Imaging1073
Gamma Imaging972
Mammography Only321

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Percent Increase in Sestamibi Retention in the Liver as a Measure of P-glycoprotein Inhibition

An area under the concentration curve (AUC) was calculated for 99mTc counts over the liver, lungs, and heart. An equation was applied to determine the increase in sestamibi in the liver: [(AUCpost - AUC baseline)/(AUC baseline)] x 100. (NCT00972205)
Timeframe: sestamibi scanning was performed on day 0 and day 6, allowing scans to be performed pre and post CBT-1 administration

Interventionpercent increase sestamibi retention (Median)
Paclitaxel and CBT-1 to Treat Solid Tumors71.9

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Percent Inhibition of Rhodamine Efflux From CD56+Cells Post Treatment

Rhodamine 123 was added to whole blood obtained before and after CBT-1. The blood was incubated, layered on lymphocyte separation medium and centrifuged. Peripheral blood mononuclear cells(PBMCs)were isolated, washed and incubated in rhodamine-free medium with or without valspodar. Cells were washed and incubated in phycoerythrin-labeled anti-CD56 antibody or negative control antibody. Rhodamine 123 fluorescence was assessed in CD56+cells with or without valspodar and a 60 min efflux period,continuing the cells without or with valspodar to generate Efflux and PSC/Efflux histograms. (NCT00972205)
Timeframe: Rhodamine efflux was performed on blood drawn prior to CBT-1 ingestion and after 6 days of dosing.

InterventionPercent inhibition of rhodamine efflux (Mean)
Paclitaxel and CBT-1 to Treat Solid Tumors78

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Number of Participants With Adverse Events

Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. (NCT00972205)
Timeframe: 18 months

InterventionParticipants (Number)
Paclitaxel and CBT-1 to Treat Solid Tumors12

[back to top]

Number of Participants Who Had an Overall Response

"Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Complete response (CR)-disappearance of all target lesions, Partial response (PR)-at least a 30% decrease in the sum of the longest diameter(LD)of target lesions, stable disease (SD) - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.~See the Protocol Link module for further details about the RECIST Criteria." (NCT00972205)
Timeframe: Baseline to progression

Interventionparticipants with response (Number)
Paclitaxel and CBT-1 to Treat Solid Tumors2

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Coronary Blood Flow Assessment With Regadenoson Stress by Cardiac MRI Between Non-diabetic and Type 1 Diabetic Subjects.

Measurement of Myocardial blood flow measurements (MBF) and myocardial perfusion index obtained from 6 regions within the mid ventricular LV short axis slice. (NCT01019486)
Timeframe: 1 month

Interventionpercentage of StressMBF/ Rest MBF (Mean)
Non Diabetic Controls2.19
Type 1 Diabetes Low Risk Group1.81
Type 1 Diabetes High Risk Group1.95

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Measured Coronary Blood Flow is Directly Correlated With Coronary Flow Reserve Measured Invasively in the Cardiac Catheterization Laboratory After Regadenoson Pharmacologic Stress.

Regional coronary blood flow reserve (CFR) in a target artery (defined on MPI study) compared to flow in a less diseased atherosclerotic vessel following vasodilator response to intravenously administered regadenoson. (NCT01019486)
Timeframe: within 6 months

InterventionCFR ratio (Mean)
Abnormal MPI Study1.5

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Myocardial Perfusion Index

Myocardial perfusion indices radionuclide stress and rest images and were obtained from 6 regions within the mid ventricular LV short axis slice. Each was corrected for decay and standardized to a 30 mCi administered dose for each part of a two day study. (NCT01019486)
Timeframe: 1 month

Interventionpercentage of Ratio Stress/ rest counts (Mean)
Non Diabetic Controls1.09
Type 1 Diabetes Low Risk Group1.4
Type 1 Diabetes High Risk Group1.12

[back to top]

Number of Participants With Reversible Defects in the Left Circumflex Coronary Artery (LCX)

"The number of reversible defects in the LCX categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT.~The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:~0: normal perfusion~1: slightly reduced contrast/radiotracer uptake~2: moderately reduced contrast/radiotracer uptake~3: severely reduced contrast/radiotracer uptake~4: absent contrast/radiotracer uptake.~The median score from 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of ≥ 2 segments with reversible defects, excluding segment 17." (NCT01334918)
Timeframe: Day 1 and Day 2

,,
Interventionparticipants (Number)
SPECT: 0 - 1 Reversible defectsSPECT: ≥ 2 Reversible defectsSPECT: All Reversible defects
CTP: ≥ 2 Reversible Defects9413
CTP: 0 - 1 Reversible Defects90292
CTP: All Reversible Defects996105

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Number of Participants With Reversible Defects in the Right Coronary Artery (RCA)

"The number of reversible defects in the RCA categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT.~The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:~0: normal perfusion~1: slightly reduced contrast/radiotracer uptake~2: moderately reduced contrast/radiotracer uptake~3: severely reduced contrast/radiotracer uptake~4: absent contrast/radiotracer uptake.~The median score from 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of ≥ 2 segments with reversible defects, excluding segment 17." (NCT01334918)
Timeframe: Day 1 and Day 2

,,
Interventionparticipants (Number)
SPECT: 0 - 1 Reversible defectsSPECT: ≥ 2 Reversible defectsSPECT: All Reversible defects
CTP: ≥ 2 Reversible Defects505
CTP: 0 - 1 Reversible Defects92193
CTP: All Reversible Defects97198

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Overall Image Quality of Scans by Modality and Reviewer

Overall image quality was assessed by three independent blinded readers for each modality (single photon emission computed tomography (SPECT) and multidetector computed tomography (MDCT)). Image quality was rated on a 4-point scale as either excellent, good, fair or poor at rest using SPECT and MDCT and under stress using regadenoson SPECT and regadenoson stress computed tomography perfusion (CTP). (NCT01334918)
Timeframe: Day 1 and Day 2

,,,,,
Interventionparticipants (Number)
Rest: ExcellentRest: GoodRest: FairRest: PoorStress: ExcellentStress: GoodStress: FairStress: Poor
MDCT: Reviewer 13056231548561
MDCT: Reviewer 240373301524629
MDCT: Reviewer 356431103736343
SPECT: Reviewer 1891641891641
SPECT: Reviewer 225533113551240
SPECT: Reviewer 3832340782750

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Percentage of Participants With Two or More Ischemic Segments on SPECT, But Less on CT

Using SPECT as the reference standard, the false negative percentage was calculated as the percentage of participants with two or more ischemic segments on SPECT, but less on CT. (NCT01334918)
Timeframe: Day 1 and Day 2

Interventionpercentage of participants (Number)
SPECT + MDCT10

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Number of Participants With Fixed Defects

"Using the 17-segment scoring system, a segment scored above 1 (i.e., 2 to 4) and equal at rest and stress was counted as having a fixed defect.~At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:~0: normal perfusion~1: slightly reduced contrast/radiotracer uptake~2: moderately reduced contrast/radiotracer uptake~3: severely reduced contrast/radiotracer uptake~4: absent contrast/radiotracer uptake." (NCT01334918)
Timeframe: Day 1 and Day 2

,,
Interventionparticipants (Number)
SPECT: 0 Fixed DefectsSPECT: ≥ 1 Fixed DefectsSPECT: All Fixed Defects
CTP: ≥ 1 Fixed Defects51015
CTP: 0 Fixed Defects92395
CTP: All Fixed Defects9713110

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Number of Participants With Reversible Defects

"The number of reversible defects categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT.~The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:~0: normal perfusion~1: slightly reduced contrast/radiotracer uptake~2: moderately reduced contrast/radiotracer uptake~3: severely reduced contrast/radiotracer uptake~4: absent contrast/radiotracer uptake.~The median score from the 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of 2 or more segments with reversible defects, excluding segment 17." (NCT01334918)
Timeframe: Day 1 and Day 2

,,
Interventionparticipants (Number)
SPECT: 0-1 Reversible defectsSPECT: ≥ 2 Reversible defectsSPECT: All Reversible defects
CTP: ≥ 2 Reversible Defects16925
CTP: 0 - 1 Reversible Defects84185
CTP: All Reversible Defects10010110

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Number of Participants With Reversible Defects in the Left Anterior Descending Coronary Artery (LAD)

"The number of reversible defects in the LAD categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT.~The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:~0: normal perfusion~1: slightly reduced contrast/radiotracer uptake~2: moderately reduced contrast/radiotracer uptake~3: severely reduced contrast/radiotracer uptake~4: absent contrast/radiotracer uptake.~The median score from 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of ≥ 2 segments with reversible defects, excluding segment 17." (NCT01334918)
Timeframe: Day 1 and Day 2

,,
Interventionparticipants (Number)
SPECT: 0 - 1 Reversible defectsSPECT: ≥ 2 Reversible defectsSPECT: All Reversible defects
CTP: ≥ 2 Reversible Defects11415
CTP: 0 - 1 Reversible Defects90090
CTP: All Reversible Defects1014105

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Diagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.

Diagnostic efficacy of flurpiridaz F18 PET MPI specificity versus SPECT specificity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard, in subgroups: pharmacologic stress, females and BMI >/=30. Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard (NCT01347710)
Timeframe: 60 days

Interventionproportion of true negatives (Number)
PET MPI specificity pharmacological stressSPECT MPI specificity pharmacological stressPET MPI specificity femalesSPECT MPI specificity femalesPET MPI specificity BMI >/=30SPECT MPI specificity BMI >/=30
Flurpiridaz F18 PET MPI.773.875.795.869.777.850

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Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).

Overall summary of sensitivity for identifying multi-vessel disease between flurpiridaz F18 PET MPI and SPECT MPI by majority rule vs. truth standard (angio >/=50% stenosis and confirmed MI). Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard (NCT01347710)
Timeframe: 60 days

Interventionproportion of true positives (Number)
PET MPI sensitivity; multivessel diseaseSPECT MPI sensitivity; multivessel disease
Flurpiridaz F18 PET MPI.410.275

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Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).

Overall summary of specificity for identifying multi-vessel disease between flurpiridaz F18 PET MPI and SPECT MPI by majority rule vs. majority rule (angio >/=50% stenosis and confirmed MI). Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard (NCT01347710)
Timeframe: 60 days

Interventionproportion of true negatives (Number)
PET MPI specificity; multivessel diseaseSPECT MPI specificity; multivessel disease
Flurpiridaz F18 PET MPI.882.964

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Overall Summary of Sensitivity of PET MPI vs SPECT MPI; Image Quality Excellent or Good

Overall summary of sensitivity of flurpiridaz F18 PET MPI (qualitative image quality of excellent or good) vs. SPECT MPI by majority rule vs. truth standard(angio >/=50% stenosis and confirmed MI). Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard (NCT01347710)
Timeframe: 60 days

Interventionproportion of true positives (Number)
PET MPI sensitivity; image quality excellent/goodSPECT MPI sensitivity image quality excellent/good
Flurpiridaz F18 PET MPI.711.539

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Image Quality of Rest and Stress (PET vs SPECT).

Overall summary of rest and stress image quality for flurpiridaz F18 PET MPI and SPECT MPI by majority rule. Value represents the number of subject images evaluated as excellent/good and fair/poor (NCT01347710)
Timeframe: 60 days

Interventionpercent of images (Number)
Rest imaging quality PET MPI; excellent/goodRest image quality SPECT MPI; excellent/goodStress image quality PET MPI; excellent/goodStress image quality SPECT MPI; excellent/goodRest image quality PET MPI; fair/poorRest image quality SPECT MPI; fair/poorstress image quality PET MPI; fair/poorStress image quality SPECT MPI; fair/poor
Flurpiridaz F18 PET MPI.891.739.976.869.109.261.024.131

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Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT).

Overall specificity of flurpiridaz F18 PET MPI in Coronary Territories (Qualitative Diagnosis) vs. SPECT MPI by majority rule vs. truth standard (angiographic stenosis greater than or equal to 50% stenosis and confirmed MI); left descending coronary artery (LAD), left circumflex artery (LCX), right coronary artery (RCA), and non - LAD. Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard (NCT01347710)
Timeframe: 60 days

Interventionproportion of true negatives (Number)
PET specificity LADSPECT specificity LADPET specificity LCXSPECT specificity LCXPET specificity RCASPECT specificity RCAPET specificity Non-LADSPECT specificity Non-LAD
Flurpiridaz F 18.867.932.904.970.845.912.814.923

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Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT).

Overall sensitivity of flurpiridaz F18 PET MPI in coronary territories (Qualitative Diagnosis vs. SPECT MPI by majority rule vs. truth standard (angiographic stenosis greater than or equal to 50% stenosis and confirmed MI); left descending coronary artery (LAD), left circumflex artery (LCX), right coronary artery (RCA), and non - LAD. Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard (NCT01347710)
Timeframe: 60 days

InterventionProportion of true positives (Number)
PET sensitivity LADSPECT sensitivity LADPET sensitivity LCXSPECT sensitivity LCXPET sensitivity RCASPECT sensitivity RCAPET sensitivity Non-LADSPECT sensitivity Non-LAD
Flurpiridaz F 18.495.333.398.251.596.476.627.464

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Diagnostic Efficacy of Flurpiridaz PET MPI Specificity Versus SPECT MPI Specificity

Diagnostic efficacy of flurpiridaz PET MPI specificity versus SPECT MPI specificity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard (NCT01347710)
Timeframe: 60 days

InterventionProportion of true negatives (Number)
PET MPI SpecificitySPECT MPI Specificity
Flurpiridaz F18.762.868

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Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.

"Diagnostic efficacy of flurpiridaz F18 PET MPI sensitivity versus SPECT MPI sensitivity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard, , in subgroups: pharmacologic stress, females and BMI >/=30. Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard~I" (NCT01347710)
Timeframe: 60 days

Interventionproportion of true postives (Number)
PET sensitivity pharmacologic stressSPECT sensitivity pharmacologic stressPET sensitivity in femalesSPECT sensitivity in femalesPET sensitivity BMI >/=30SPECT sensitivity BMI >/=30
Flurpiridaz F18 PET MPI0.7360.5330.6440.3560.7220.533

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Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity

Diagnostic efficacy of one day rest and stress flurpiridaz F 18 PET MPI sensitivity versus SPECT MPI sensitivity in the detection of coronary artery disease (CAD) by majority rule using invasive coronary angiography as the truth standard, (NCT01347710)
Timeframe: 60 days

InterventionProportion of true positive cases (Number)
PET MPI sensitivitySPECT MPI Sensitivity
Flurpiridaz F18 PET MPI.719.537

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Overall Summary of Specificity of PET MPI vs SPECT MPI; Image Quality of Excellent or Good

Overall summary of specificity of flurpiridaz F18 PET MPI (qualitative, image quality excellent or good) vs. SPECT MPI by majority rule vs truth standard (angio >/=50% stenosis and confirmed MI). Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard (NCT01347710)
Timeframe: 60 days

Interventionproportion of true negatives (Number)
PET MPI specificity; image quality excellent/goodSPECT MPI specificity image quality excellent/good
Flurpiridaz F18 PET MPI.769.880

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Diagnostic Certainty in PET MPI and SPECT MPI

Overall summary of diagnostic certainty in flurpiridaz F18 PET MPI and SPECT MPI by majority rule (NCT01347710)
Timeframe: 60 days

Interventionproportion of patients (Number)
PET definitely normal/abnormalPET probably/equivocalSPECT definitely normal/abnormalSPECT probably/equivocal
Flurpiridaz F 180.8620.1380.7990.201

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Diagnostic Confidence Score

Each reconstructed image was subjectively scored by the expert readers to determine the expert reader's diagnostic confidence in scoring and interpreting the perfusion scores. The Diagnostic Confidence Score of the reconstructed images were graded on a 4-point scale. (1=Poor; 2=Fair; 3=Good; and 4=Excellent). (NCT01499654)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Half-dose WBR2.5
Half-dose FBP2.7
Full-dose FBP3.0

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Image Quality Score

Each reconstructed image was subjectively scored by the expert readers to determine the overall image quality. The Image Quality Score of the reconstructed images were graded on a 4-point scale. (1=Poor; 2=Fair; 3=Good; and 4=Excellent). (NCT01499654)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Half-dose WBR2.3
Half-dose FBP2.6
Full-dose FBP3.0

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Injection and Scan Times

Time in minutes between doses of resting Tc-99m sestamibi doses and image scanning. (NCT01499654)
Timeframe: Baseline

Interventionminutes (Mean)
Injection 1 to Scan 130.0
Injection 2 to Scan 233.1
Injection 1 to Injection 256.7

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Resting Full-Tracer Dose

Amount of the standard, clinically-accepted, full-dose Tc-99m sestamibi dose administered (NCT01499654)
Timeframe: Baseline

Interventionmillicurie (Mean)
Study Group9.08

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Segments With Resting Perfusion Defect

Left ventricular myocardium was divided into standardized 17-segments with 6 equiangular segments in the basal region, 6 equiangular segments in the mid region, 4 equiangular segments in the apical regions, and 1 region in the apex (Cerqueira MD, et al., J Nucl Cardiol 2002;9:240-5). Each segment was scored on a scale from 0 to 4 to indicate the severity of the perfusion defect (0=no perfusion defect; 1=mild perfusion defect; 2=moderate perfusion defect; 3=severe perfusion defect; and 4=absent perfusion). The number of segments with a score of 1 or greater were summed to obtain the number of segments with a resting perfusion defect. (NCT01499654)
Timeframe: Baseline

Interventionsegments (Mean)
Half-dose WBR4.6
Half-dose FBP4.0
Full-dose FBP3.8

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Sum Rest Score

Left ventricular myocardium was divided into standardized 17-segments with 6 equiangular segments in the basal region, 6 equiangular segments in the mid region, 4 equiangular segments in the apical regions, and 1 region in the apex (Cerqueira MD, et al., J Nucl Cardiol 2002;9:240-5). Each segment was scored on a scale from 0 to 4 to indicate the severity of the perfusion defect (0=no perfusion defect; 1=mild perfusion defect; 2=moderate perfusion defect; 3=severe perfusion defect; and 4=absent perfusion). The scores over 17 segments were summed to report the Sum Rest Score (SRS), ie. the greater the SRS, the larger the perfusion defect. (NCT01499654)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Half-dose WBR8.1
Half-dose FBP6.7
Full-dose FBP6.5

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Biopsy Rate

Biopsy rate = number of participants who had a biopsy/number of number of participants analyzed. (NCT01925170)
Timeframe: 12 months after mammography and MBI

Interventionpercentage of participants (Number)
Mammography Only1.3
Mammography With Adjunct MBI4.2
Molecular Breast Imaging Alone3.2

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Recall Rate

Recall rate was defined as the percentage of participants recalled for follow-up studies initiated because of abnormal findings with mammography or MBI. (NCT01925170)
Timeframe: 12 months after mammography and MBI

Interventionpercentage of participants (Number)
Mammography Only11.0
Mammography With Adjunct MBI17.6
Molecular Breast Imaging Alone7.5

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Sensitivity for All Cancers Diagnosed

Sensitivity measures the percentage of actual positives which are correctly identified as such. (NCT01925170)
Timeframe: Within 21 days of mammography

Interventionpercentage of actual positives (Number)
Mammography Only23.8
Mammography With Adjunct MBI90.5
Molecular Breast Imaging Alone81.0

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Specificity

Specificity measures the percentage of negatives which are correctly identified as such. (NCT01925170)
Timeframe: Within 21 days of mammography

Interventionpercentage of true negatives (Number)
Mammography Only89.1
Mammography With Adjunct MBI83.4
Molecular Breast Imaging Alone93.5

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Cancer Detection Rate Per 1000 Women Screened, by Breast Density

The cancer detection rate per 1000 women screened is the estimate of the number of women with positive results from a screening test. (NCT01925170)
Timeframe: Within 21 days of mammography

,,
Interventioncancers per 1000 women screened (Number)
All densitiesScattered fibroglandular densitiesHeterogeneously denseExtremely dense
Mammography Only3.203.34.5
Mammography With Adjunct MBI12.021.010.613.6
Molecular Breast Imaging Alone10.721.09.013.6

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Lesion Detection on 99mTc Sestamibi Study

Any area of radioactivity will be graded by a team of two blinded nuclear medicine physicians to determine if the uptake focus is metastatic disease. (NCT03065218)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
99mTc Sestamilbi1

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