Page last updated: 2024-12-08

edotreotide

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

Description

Edotreotide: DOTA - 1,4,7,10-tetraazacyclododecanetetracetic acid; structure given in first source; may be labelled with various radioisotopes [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID158782
CHEMBL ID408350
SCHEMBL ID1649285
SCHEMBL ID19712197
MeSH IDM0276923

Synonyms (29)

Synonym
edotreotide
bdbm50165171
smt-487
smt487
smt 487
dotatoc
CHEMBL408350 ,
n-((4,7,10-tris(carboxymethyl)-1,4,7,10-tetraazacycoldodec-1-yl)acetyl-d-phenylalanyl-l-cysteinyl-l-tyrosyl-d-tryprophyl-l-lysyl-l-threonyl-n-((1r,2r)-2-hydroxy-1-(hydroxymethyl)propyl)-l-cysteinamide cyclic (2-7)-disulfide
edotreotide [usan:inn]
n-((4,7,10-tris(carboxymethyl)-1,4,7,10-tetraazacycoldodec-1-yl)acetyl-d-phenylalanyl-l-cysteinyl-l-tyrosyl-d-tryprophyl-l-lysyl-l-threonyl-n-((1r,2r)-2-hydroxy-1-(hydroxymethyl)propyl)-l cysteinamide cyclic (2-7)-disulfide
u194as08hz ,
unii-u194as08hz
l-cysteinamide, n-((4,7,10-tris(carboxymetnyl)-1,4,7,10-tetraazacyclodec-1-yl)acetyl)-d-phenylalanyl-l-cysteinyl-l-tyrosyl-d-tryptophyl-l-lysyl-l-threonyl-n-((1r,2r)-2-hydroxy-1-(hydroxymethyl)propyl)-, cyclic(2-7)-disulfide
RZHKDBRREKOZEW-AAXZNHDCSA-N
edotreotide [usan]
edotreotide [mi]
l-cysteinamide, n-((4,7,10-tris(carboxymetnyl)-1,4,7,10-tetraazacyclodec-1-yl)acetyl)-d-phenylalanyl-l-cysteinyl-l-tyrosyl-d-tryptophyl-l-lysyl-l-threonyl-n-((1r,2r)-2-hydroxy-1-(hydroxymethyl)propyl)-, cyclic(2->7)-disulfide
n-((4,7,10-tris(carboxymethyl)-1,4,7,10-tetraazacycoldodec-1-yl)acetyl-d-phenylalanyl-l-cysteinyl-l-tyrosyl-d-tryprophyl-l-lysyl-l-threonyl-n-((1r,2r)-2-hydroxy-1-(hydroxymethyl)propyl)-l-cysteinamide cyclic (2->7)-disulfide
edotreotide [inn]
SCHEMBL1649285
n-acetyl-lys-octreotide
173606-11-6
SCHEMBL19712197
dota-toc
EX-A4065
Q908790
DTXSID701021591
CS-0024683
HY-106033

Research Excerpts

Compound-Compound Interactions

ExcerptReferenceRelevance
" These results indicate that high activities of (90)Y-DOTATOC can be administered with low risk of myelotoxicity, although with potentially high radiation doses to the spleen and kidneys."( Biokinetics and dosimetry in patients administered with (111)In-DOTA-Tyr(3)-octreotide: implications for internal radiotherapy with (90)Y-DOTATOC.
Chinol, M; Cremonesi, M; Ferrari, M; Fiorenza, M; Jermann, E; Maecke, HR; Orsi, F; Paganelli, G; Robertson, C; Stabin, MG; Tosi, G; Zoboli, S, 1999
)
0.3

Dosage Studied

ExcerptRelevanceReference
"1 GBq per cycle in escalating dosage (0."( Receptor-mediated radionuclide therapy with 90Y-DOTA-D-Phe1-Tyr3-Octreotide: preliminary report in cancer patients.
Chinol, M; Cremonesi, M; Mäcke, HR; Paganelli, G; Zoboli, S, 1999
)
0.3
" Five GBq per cycle is the recommended dosage of (90)Y-DOTATOC when amino acids are given to protect the kidneys."( Receptor-mediated radionuclide therapy with 90Y-DOTATOC in association with amino acid infusion: a phase I study.
Bartolomei, M; Bodei, L; Caracciolo, M; Chinol, M; Cremonesi, M; Grana, C; Mäcke, HR; Paganelli, G; Rocca, P; Zoboli, S, 2003
)
0.32
" Dosimetry using combined anatomical and functional imaging is being developed for patient-specific dosing of targeted radiotherapy and as an extremely sensitive monitor of response to therapy."( Combining anatomic and molecularly targeted imaging in the diagnosis and surveillance of embryonal tumors of the nervous and endocrine systems in children.
Bushnell, D; Khanna, G; O'Dorisio, MS, 2008
)
0.35
" Multivariable Cox regression and competing risk regression were used to compare efficacy and toxicities of the different dosage protocols."( Somatostatin-based radiotherapy with [90Y-DOTA]-TOC in neuroendocrine tumors: long-term outcome of a phase I dose escalation study.
Briel, M; Brunner, P; Jörg, AC; Koller, MT; Maecke, HR; Marincek, N; Müller-Brand, J; Rochlitz, C; Schindler, C; Walter, MA, 2013
)
0.39
" However, there has yet to be a dose optimization study across the patient population, and methods are currently lacking to optimize dosing of octreotide therapy on an individual basis."( Free somatostatin receptor fraction predicts the antiproliferative effect of octreotide in a neuroendocrine tumor model: implications for dose optimization.
Habibollahi, P; Heidari, P; Kulke, M; Mahmood, U; Wehrenberg-Klee, E; Yokell, D, 2013
)
0.39
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Protein Targets (5)

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Somatostatin receptor type 1Homo sapiens (human)IC50 (µMol)10.00000.00010.00130.0022AID242772
Somatostatin receptor type 2Homo sapiens (human)IC50 (µMol)0.01400.00040.00240.0140AID242749
Somatostatin receptor type 4Homo sapiens (human)IC50 (µMol)1.00000.00010.00210.0042AID242759
Somatostatin receptor type 3Homo sapiens (human)IC50 (µMol)0.88000.00040.11100.8800AID242753
Somatostatin receptor type 5Homo sapiens (human)IC50 (µMol)0.39300.00020.04720.3930AID242776
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (23)

Processvia Protein(s)Taxonomy
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerSomatostatin receptor type 1Homo sapiens (human)
glutamate receptor signaling pathwaySomatostatin receptor type 1Homo sapiens (human)
spermatogenesisSomatostatin receptor type 1Homo sapiens (human)
negative regulation of cell population proliferationSomatostatin receptor type 1Homo sapiens (human)
cerebellum developmentSomatostatin receptor type 1Homo sapiens (human)
forebrain developmentSomatostatin receptor type 1Homo sapiens (human)
somatostatin signaling pathwaySomatostatin receptor type 1Homo sapiens (human)
response to starvationSomatostatin receptor type 1Homo sapiens (human)
cellular response to leukemia inhibitory factorSomatostatin receptor type 1Homo sapiens (human)
cellular response to estradiol stimulusSomatostatin receptor type 1Homo sapiens (human)
neuropeptide signaling pathwaySomatostatin receptor type 1Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerSomatostatin receptor type 2Homo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled receptor signaling pathwaySomatostatin receptor type 2Homo sapiens (human)
spermatogenesisSomatostatin receptor type 2Homo sapiens (human)
negative regulation of cell population proliferationSomatostatin receptor type 2Homo sapiens (human)
cerebellum developmentSomatostatin receptor type 2Homo sapiens (human)
peristalsisSomatostatin receptor type 2Homo sapiens (human)
forebrain developmentSomatostatin receptor type 2Homo sapiens (human)
somatostatin signaling pathwaySomatostatin receptor type 2Homo sapiens (human)
response to starvationSomatostatin receptor type 2Homo sapiens (human)
cellular response to glucocorticoid stimulusSomatostatin receptor type 2Homo sapiens (human)
cellular response to estradiol stimulusSomatostatin receptor type 2Homo sapiens (human)
neuropeptide signaling pathwaySomatostatin receptor type 2Homo sapiens (human)
G protein-coupled receptor signaling pathwaySomatostatin receptor type 4Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerSomatostatin receptor type 4Homo sapiens (human)
negative regulation of cell population proliferationSomatostatin receptor type 4Homo sapiens (human)
cell migrationSomatostatin receptor type 4Homo sapiens (human)
forebrain developmentSomatostatin receptor type 4Homo sapiens (human)
somatostatin signaling pathwaySomatostatin receptor type 4Homo sapiens (human)
positive regulation of ERK1 and ERK2 cascadeSomatostatin receptor type 4Homo sapiens (human)
positive regulation of arachidonic acid secretionSomatostatin receptor type 4Homo sapiens (human)
negative regulation of adenylate cyclase-activating G protein-coupled receptor signaling pathwaySomatostatin receptor type 4Homo sapiens (human)
neuropeptide signaling pathwaySomatostatin receptor type 4Homo sapiens (human)
cellular response to glucocorticoid stimulusSomatostatin receptor type 4Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerSomatostatin receptor type 3Homo sapiens (human)
cell-cell signalingSomatostatin receptor type 3Homo sapiens (human)
spermatogenesisSomatostatin receptor type 3Homo sapiens (human)
negative regulation of cell population proliferationSomatostatin receptor type 3Homo sapiens (human)
hormone-mediated apoptotic signaling pathwaySomatostatin receptor type 3Homo sapiens (human)
cerebellum developmentSomatostatin receptor type 3Homo sapiens (human)
forebrain developmentSomatostatin receptor type 3Homo sapiens (human)
somatostatin signaling pathwaySomatostatin receptor type 3Homo sapiens (human)
response to starvationSomatostatin receptor type 3Homo sapiens (human)
cellular response to glucocorticoid stimulusSomatostatin receptor type 3Homo sapiens (human)
cellular response to estradiol stimulusSomatostatin receptor type 3Homo sapiens (human)
neuropeptide signaling pathwaySomatostatin receptor type 3Homo sapiens (human)
G protein-coupled receptor signaling pathwaySomatostatin receptor type 5Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerSomatostatin receptor type 5Homo sapiens (human)
negative regulation of cell population proliferationSomatostatin receptor type 5Homo sapiens (human)
positive regulation of cytokinesisSomatostatin receptor type 5Homo sapiens (human)
somatostatin signaling pathwaySomatostatin receptor type 5Homo sapiens (human)
cellular response to glucocorticoid stimulusSomatostatin receptor type 5Homo sapiens (human)
neuropeptide signaling pathwaySomatostatin receptor type 5Homo sapiens (human)
regulation of insulin secretionSomatostatin receptor type 5Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (6)

Processvia Protein(s)Taxonomy
somatostatin receptor activitySomatostatin receptor type 1Homo sapiens (human)
protein bindingSomatostatin receptor type 1Homo sapiens (human)
neuropeptide bindingSomatostatin receptor type 1Homo sapiens (human)
protein bindingSomatostatin receptor type 2Homo sapiens (human)
PDZ domain bindingSomatostatin receptor type 2Homo sapiens (human)
somatostatin receptor activitySomatostatin receptor type 2Homo sapiens (human)
neuropeptide bindingSomatostatin receptor type 2Homo sapiens (human)
protein bindingSomatostatin receptor type 4Homo sapiens (human)
somatostatin receptor activitySomatostatin receptor type 4Homo sapiens (human)
neuropeptide bindingSomatostatin receptor type 4Homo sapiens (human)
somatostatin receptor activitySomatostatin receptor type 3Homo sapiens (human)
signaling receptor bindingSomatostatin receptor type 3Homo sapiens (human)
protein bindingSomatostatin receptor type 3Homo sapiens (human)
neuropeptide bindingSomatostatin receptor type 3Homo sapiens (human)
G protein-coupled receptor activitySomatostatin receptor type 3Homo sapiens (human)
protein bindingSomatostatin receptor type 5Homo sapiens (human)
neuropeptide bindingSomatostatin receptor type 5Homo sapiens (human)
somatostatin receptor activitySomatostatin receptor type 5Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (6)

Processvia Protein(s)Taxonomy
plasma membraneSomatostatin receptor type 1Homo sapiens (human)
plasma membraneSomatostatin receptor type 1Homo sapiens (human)
neuron projectionSomatostatin receptor type 1Homo sapiens (human)
cytosolSomatostatin receptor type 2Homo sapiens (human)
plasma membraneSomatostatin receptor type 2Homo sapiens (human)
neuron projectionSomatostatin receptor type 2Homo sapiens (human)
plasma membraneSomatostatin receptor type 2Homo sapiens (human)
plasma membraneSomatostatin receptor type 4Homo sapiens (human)
neuron projectionSomatostatin receptor type 4Homo sapiens (human)
plasma membraneSomatostatin receptor type 4Homo sapiens (human)
plasma membraneSomatostatin receptor type 3Homo sapiens (human)
ciliumSomatostatin receptor type 3Homo sapiens (human)
ciliary membraneSomatostatin receptor type 3Homo sapiens (human)
non-motile ciliumSomatostatin receptor type 3Homo sapiens (human)
neuron projectionSomatostatin receptor type 3Homo sapiens (human)
plasma membraneSomatostatin receptor type 3Homo sapiens (human)
plasma membraneSomatostatin receptor type 5Homo sapiens (human)
plasma membraneSomatostatin receptor type 5Homo sapiens (human)
neuron projectionSomatostatin receptor type 5Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (5)

Assay IDTitleYearJournalArticle
AID242759In vitro inhibition of [125I][Leu8,D-Trp22,Tyr25] somatostatin 28 binding to human somatostatin receptor type 4 expressed in CCL39 cells; (n=6)2005Journal of medicinal chemistry, Apr-21, Volume: 48, Issue:8
N-terminal sugar conjugation and C-terminal Thr-for-Thr(ol) exchange in radioiodinated Tyr3-octreotide: effect on cellular ligand trafficking in vitro and tumor accumulation in vivo.
AID242772In vitro inhibition of [125I][Leu8,D-Trp22,Tyr25] somatostatin 28 binding to human somatostatin receptor type 1 expressed in CHO-K1 cells; (n=7)2005Journal of medicinal chemistry, Apr-21, Volume: 48, Issue:8
N-terminal sugar conjugation and C-terminal Thr-for-Thr(ol) exchange in radioiodinated Tyr3-octreotide: effect on cellular ligand trafficking in vitro and tumor accumulation in vivo.
AID242749In vitro inhibition of [125I][Leu8,D-Trp22,Tyr25] somatostatin 28 binding to human somatostatin receptor type 2 expressed in CCL39 cells; (n=6)2005Journal of medicinal chemistry, Apr-21, Volume: 48, Issue:8
N-terminal sugar conjugation and C-terminal Thr-for-Thr(ol) exchange in radioiodinated Tyr3-octreotide: effect on cellular ligand trafficking in vitro and tumor accumulation in vivo.
AID242776In vitro inhibition of [125I][Leu8,D-Trp22,Tyr25] somatostatin 28 binding to human somatostatin receptor type 5 expressed in CHO-K1 cells; (n=6)2005Journal of medicinal chemistry, Apr-21, Volume: 48, Issue:8
N-terminal sugar conjugation and C-terminal Thr-for-Thr(ol) exchange in radioiodinated Tyr3-octreotide: effect on cellular ligand trafficking in vitro and tumor accumulation in vivo.
AID242753In vitro inhibition of [125I][Leu8,D-Trp22,Tyr25] somatostatin 28 binding to human somatostatin receptor type 3 expressed in CCL39 cells; (n=4)2005Journal of medicinal chemistry, Apr-21, Volume: 48, Issue:8
N-terminal sugar conjugation and C-terminal Thr-for-Thr(ol) exchange in radioiodinated Tyr3-octreotide: effect on cellular ligand trafficking in vitro and tumor accumulation in vivo.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (195)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's14 (7.18)18.2507
2000's85 (43.59)29.6817
2010's69 (35.38)24.3611
2020's27 (13.85)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 31.57

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 moderate demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index31.57 (24.57)
Research Supply Index5.48 (2.92)
Research Growth Index5.05 (4.65)
Search Engine Demand Index39.41 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (31.57)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials34 (16.50%)5.53%
Reviews12 (5.83%)6.00%
Case Studies36 (17.48%)4.05%
Observational1 (0.49%)0.25%
Other123 (59.71%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (37)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Prognostic Interest of a Whole Body Dynamic PET Acquisition in Pre-therapeutic 68Ga-DOTATOC PET/CT for Neuroendocrine Tumors [NCT03576040]120 participants (Anticipated)Observational2018-07-19Recruiting
Selective Intra-arterial Injection of Peptide Receptor Radionuclide Therapy (PRRT) in Neuroendocrine Tumor Patients With Liver Metastases [NCT03724409]Early Phase 13 participants (Actual)Interventional2018-10-11Terminated(stopped due to Pandemic)
Early Feasibility Study of Somatostatin Receptors PET Imaging (68Ga-DOTATOC PET/CT) for the Diagnosis of Infective Endocarditis [NCT05183555]Phase 214 participants (Anticipated)Interventional2022-04-30Not yet recruiting
Yttrium-90 DOTA-TOC Intra-arterial (IA) Peptide Receptor Radionuclide Therapy (PRRT) for Neuroendocrine Tumor [NCT03197012]Early Phase 110 participants (Actual)Interventional2017-07-01Completed
An Open-label, Single Arm Clinical Trial of Gallium (68Ga) Edotreotide PET-CT Scan for Imaging Patients With Gastrointestinal Pancreatic Neuroendocrine Tumors [NCT06091748]Phase 366 participants (Anticipated)Interventional2023-11-01Not yet recruiting
Efficacy of 68Ga-DOTATOC Positron Emission Tomography (PET) CT in Children and Young Adults With Brain Tumors [NCT02194452]0 participants (Actual)Interventional2013-09-30Withdrawn
Studio Esplorativo Monocentrico Non Controllato, in Aperto, Volto a Sviluppare e Valutare l'Applicazione di Una Tecnica Innovativa di Rimozione Radioguidata Dei Tumori Neuroendocrini Gastro-entero-pancreatici [NCT04296149]Phase 25 participants (Actual)Interventional2017-02-16Completed
Diagnosis and Staging of Neuroendocrine Tumors (NETs) Utilizing 68Ga-DOTATOC PET/CT Scan [NCT03136328]Phase 311 participants (Actual)Interventional2016-05-16Completed
Ga-68-DOTATOC -PET in the Management of Pituitary Tumours [NCT02419664]Phase 322 participants (Actual)Interventional2015-01-31Terminated(stopped due to The hypothesis we had that we could predict the growth rate from PET uptake could not be confirmer and 3-year follow up was no longer considered motivated)
Development of an Innovative Gallium 68 Radiolabeling of DOTATOC (68Ga-DOTATOC) for PET-CT Imaging of Neuro-endocrine Tumors and Preliminary Clinical Evaluation [NCT02134639]20 participants (Actual)Observational2014-09-30Completed
Peptide Receptor Radionuclide Therapy (PRRT) in Tumors With High Expression of Somatostatin Receptors [NCT04790708]250 participants (Anticipated)Interventional2018-07-02Recruiting
Somatostatin Receptor Imaging in Inflammatory Heart Disease [NCT04206163]80 participants (Anticipated)Interventional2020-01-20Recruiting
A Phase II, Open-label, Multi-Center Study to Evaluate the Efficacy of 90Y-SMT 487 Administered Intravenously to Patients With Refractory Small Cell Lung or Advanced Metastatic Breast Cancer Expressing Somatostatin Receptors as Determined by OctreoScan Sc [NCT00006370]Phase 2275 participants (Actual)Interventional2000-07-31Completed
A Sub-study of 18F-DCFPyL Positron Emission Tomography / Computed Tomography (PET/CT) for Assessment of Recurrent Prostate Cancer Evaluation of the Safety and Sensitivity of 68Ga-DOTATOC PET/CT for Imaging NET Patients [NCT04017104]60 participants (Anticipated)Observational2019-11-01Recruiting
68Ga-DOTATOC PET for the Evaluation of Gastroenteropancreatic Neuroendocrine Tumours [NCT06155318]300 participants (Anticipated)Observational2019-09-05Recruiting
Neoadjuvant Peptide Receptor Radionuclide Therapy (PRRT) With 90Y-DOTATOC in Pancreatic Neuroendocrine Tumours. [NCT05568017]Phase 26 participants (Anticipated)Interventional2020-09-15Recruiting
A Phase II Open-label Multi-center Study to Evaluate the Efficacy and Safety of 90Y-SMT487 in Subjects With Symptomatic Malignant Carcinoid Tumors [NCT00696930]Phase 20 participants (Actual)Interventional2008-06-30Withdrawn
Prospective Longitudinal Observation Trial of Clinical and Molecular Features of Pancreatic Neuroendocrine Tumours [NCT03741517]40 participants (Anticipated)Observational [Patient Registry]2019-01-30Recruiting
PET/CT Imaging of Malignant Glioma With Somatostatin Analog 68Ga-DOTATOC [NCT01460706]Phase 2/Phase 330 participants (Actual)Interventional2011-10-31Completed
SSTR2-Targeted PET Imaging of Meningioma: Direct Comparison of Ga-68-DOTATATE and Ga-68-DOTATOC [NCT04298541]Phase 26 participants (Anticipated)Interventional2021-03-18Recruiting
Efficacy, Safety and Patient-reported Outcomes of Peptide Receptor Radionuclide Therapy With 177Lu-edotreotide Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus. [NCT05918302]Phase 3120 participants (Anticipated)Interventional2023-10-27Recruiting
A Phase I, Open-Label, Maximum Tolerated Single-Cycle and Four-Cycle Dose-Finding Study to Evaluation the Safety and Tolerability of 90Y-SMT 487 Administered by Intravenous Infusion to Subjects With Refractory Somatostatin-Receptor Positive Tumors [NCT00006368]Phase 160 participants (Actual)Interventional1998-01-31Completed
A Phase I, Open Label, Maximum Tolerated Dose-Finding Study to Evaluate the Safety and Tolerability of 90Y-DOTA-tyr3-Octreotide Administered by Intravenous Infusion to Children With Refractory Somatostatin-Receptor Positive Tumors [NCT00049023]Phase 127 participants (Actual)Interventional2002-01-31Completed
Phase II, Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC) in Children and Adults With Neuroendocrine and Other Somatostatin Receptor Expressing Tumors [NCT03013387]Phase 20 participants (Actual)Interventional2017-01-31Withdrawn(stopped due to This project has undergone a significant amount of updates and has been resubmitted under IRB# 201708778)
Phase II, Dosimetry Guided, Peptide Receptor Radiotherapy (PRRT) Using 90Y-DOTA tyr3-Octreotide (90Y-DOTATOC) in Children and Adults With Neuroendocrine and Other Somatostatin Receptor Positive Tumors [NCT03273712]Phase 239 participants (Actual)Interventional2017-09-29Completed
Comparator Study of 68Ga-DOTATOC PET/CT With Octreoscan + High-resolution, Contrast-enhanced CT for Diagnosis and Staging in Neuroendocrine Tumors and Other Somatostatin Receptor Positive Tumors [NCT01869725]Phase 268 participants (Actual)Interventional2013-04-01Completed
Evaluation of Gallium-68 DOTA-TOC Imaging of Somatostatin Receptor Positive Malignancies [NCT02177773]Phase 1/Phase 2300 participants (Actual)Interventional2014-06-23Terminated(stopped due to FDA approved agent for this indication during enrollment)
Safety & Efficacy of 68Ga-DOTA-tyr3-Octreotide PET/CT in Diagnosis, Staging & Measurement of Response to Treatment in Patients With Somatostatin Receptor Positive Tumors: Comparison to Octreoscan Plus High-Resolution, Contrast Enhanced CT. [NCT01619865]Phase 1/Phase 2223 participants (Actual)Interventional2012-02-21Completed
Safety and Efficacy Study of 68Ga-Dotatoc Positron Emission Tomography for Diagnosis for Staging, Restaging and Assessment of Response to Treatment in Somatostatin Receptor-Positive Neuroendocrine Tumors [NCT02359500]Phase 171 participants (Actual)Interventional2014-12-31Terminated(stopped due to compound no longer available)
68Ga-DOTATOC for Imaging of Neuroendocrine Tumors: Expanded Access Trial [NCT02358018]0 participants Expanded AccessNo longer available
Monocentric Interventionnal Pilot Study Pilot Study Evaluating Somatostatin Receptor's PET Imaging to Detect Inflammatory Phases of Myocarditis [NCT03347760]33 participants (Anticipated)Interventional2020-07-13Recruiting
An Expanded Access Imaging of Neuroendocrine Tumors Using 68Ga-DOTA-TOC [NCT03001349]Early Phase 14 participants (Actual)Interventional2017-05-16Terminated(stopped due to Per PI Request)
A Prospective, Randomised, Controlled, Open-label, Multicentre Study to Evaluate Efficacy, Safety and Patient-Reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Best Standard of Care in Patients With Well- [NCT04919226]Phase 3202 participants (Anticipated)Interventional2021-12-21Recruiting
Peptide Receptor Radionuclide Therapy With 90Y-Dotatoc in Relapsed/Refractory Diffuse Large B Cell (DLBCL) and Mantle Cell Lymphomas (MCL) [NCT02488512]Phase 21 participants (Actual)Interventional2016-12-22Terminated(stopped due to critical low recruitment rate)
Evaluation of the Safety and Sensitivity of 68Ga-DOTATOC PET/CT for Imaging NET Patients [NCT03583528]800 participants (Anticipated)Observational2018-07-11Recruiting
A Prospective, Randomised, Controlled, Open-label, Multicentre Phase III Study to Evaluate Efficacy and Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Targeted Molecular Therapy With Everolimus in Patients With I [NCT03049189]Phase 3309 participants (Actual)Interventional2017-02-02Active, not recruiting
Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors [NCT02441062]Phase 2122 participants (Actual)Interventional2015-09-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT01619865 (1) [back to overview]To Measure Safety of 68Ga-DOTATOC Positron Emission Tomography (PET) by Measuring the Number of Adverse Events Related to the Investigational Radiopharmaceutical Agent
NCT01869725 (3) [back to overview]Compare Sensitivity of 68Ga-DOTATOC PET/CT With Octreoscan
NCT01869725 (3) [back to overview]Compare Specificity of 68Ga-DOTATOC PET/CT With Octreoscan
NCT01869725 (3) [back to overview]Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology
NCT03136328 (2) [back to overview]Sensitivity to Correctly Diagnose NET
NCT03136328 (2) [back to overview]Specificity to Detect True Negative
NCT03273712 (2) [back to overview]Percentage of Patients With Grade 4 or Higher Irreversible Adverse Events
NCT03273712 (2) [back to overview]Percentage of Patients With Grade 4 or Higher Renal Adverse Event.
[back to top]

Compare Sensitivity of 68Ga-DOTATOC PET/CT With Octreoscan

Compare sensitivity of 68Ga-DOTATOC PET/CT with Octreoscan + high-resolution, contrast-enhanced CT for diagnosis and staging in neuroendocrine tumors and other somatostatin receptor positive tumors (NCT01869725)
Timeframe: Up to 6 months

Interventionpercentage of sensitivity (Number)
Sensitivity of Ga-68-DOTATOCSensitivity of OctreoScanSensitivity of Conventional Imaging (CI)
Diagnostic (Gallium Ga 68-edotreotide PET/CT)96.5579.3182.24

[back to top]

Compare Specificity of 68Ga-DOTATOC PET/CT With Octreoscan

Compare specificity of 68Ga-DOTATOC PET/CT with Octreoscan + high-resolution, contrast-enhanced CT for diagnosis and staging in neuroendocrine tumors and other somatostatin receptor positive tumors (NCT01869725)
Timeframe: 6 months

Interventionpercentage of specificity (Number)
Specificity of 68Ga-DOTATOCSpecificity of OctreoscanSpecificity of Conventional Imaging (CI)
Diagnostic (Gallium Ga 68-edotreotide PET/CT)10010047.82

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Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology

Tumor lesions detected on 68Ga-DOTATOC PET/CT compared with tumor lesions detected on Octreoscan SPECT imaging plus high-resolution, contrast-enhanced CT. (NCT01869725)
Timeframe: Up to 6 months between the timing of the Octreoscan SPECT/CT plus high-resolution, contrast-enhanced CT and the time of the 68Ga-DOTATOC PET/CT (either imaging type may occur first)

InterventionParticipants (Count of Participants)
Sensitivity and Specificity for Ga-68-DOTATOC as Compared to Pathology72023597Sensitivity and Specificity for OctreoScan as Compared to Pathology72023597
Total positiveFalse positionFalse negativeTotal negative
Diagnostic (Gallium Ga 68-edotreotide PET/CT)28
Diagnostic (Gallium Ga 68-edotreotide PET/CT)1
Diagnostic (Gallium Ga 68-edotreotide PET/CT)23
Diagnostic (Gallium Ga 68-edotreotide PET/CT)0
Diagnostic (Gallium Ga 68-edotreotide PET/CT)6
Diagnostic (Gallium Ga 68-edotreotide PET/CT)5

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Sensitivity to Correctly Diagnose NET

Sensitivity to detect NET will be assessed and compared with conventional imaging modality. Sensitivity is the ability of an agent to indicate the presence and location of NET. The ability of 68Ga-DOTATOC to localize more effectively to somatostatin receptors and the exquisite spatial resolution of PET/CT should make easier detection of primary and metastatic neuroendocrine tumors and allow better measurement of tumor burden. Sensitivity is the percentage of accurately diagnosed NET cases. All participants underwent conventional imaging with either Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) as standard care prior to 68Ga-DOTATOC imaging. (NCT03136328)
Timeframe: During imaging process ( approximately 120 minutes)

,
Interventionpercent of NET correctly diagnosed (Number)
Primary lesionsLiver metastasesLymph node metastasisBone metastasis
68Ga-DOTATOC PET/CT75100100100
Conventional Imaging75754050

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Specificity to Detect True Negative

A tumor is an abnormal growth of cells which can be malignant or not. NET tumors secrete hormones that will disrupt the normal ecology of the body. 68Ga-DOTATOC is extremely sensitive and specific to the receptors expressed by NET. These attributes are unique to 68Ga-DOTATOC and makes it the only imagining technique that can determine whether or not lesions detected by conventional imaging is due to NET involvement. 68Ga-DOTATOC is able to exclude disease involvement in lesions detected on CT/MRI; this ability to exclude disease involvement is called Specificity. The reported values indicate the specificity of 68Ga-DOTATOC, which is the percentage of tumors detected by conventional imagining that 68Ga-DOTATOC correctly determined were not due to NET involvement (i.e. identifying true negative for NET). (NCT03136328)
Timeframe: During imaging process ( approximately 120 minutes)

Interventionpercent of tumors identified as non-NET (Number)
Primary lesionsLiver metastases
68Ga-DOTATOC PET/CT100100

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Percentage of Patients With Grade 4 or Higher Irreversible Adverse Events

The percentage of patients who experience a grade 4 or higher irreversible adverse event. Adverse events were graded using CTCAE v4.0 criteria. (NCT03273712)
Timeframe: Initiation of treatment through last follow-up visit (6-9 months after last treatment), up to approximately 10-13 months.

InterventionParticipants (Count of Participants)
90Y-DOTA-tyr3-Octreotide0

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Percentage of Patients With Grade 4 or Higher Renal Adverse Event.

The percentage of patients who experience a grade 4 or higher renal adverse event. Renal adverse events were graded using CTCAE v4.0 criteria. (NCT03273712)
Timeframe: Initiation of treatment through last follow-up visit (6-9 months after last treatment), up to approximately 10-13 months.

InterventionParticipants (Count of Participants)
90Y-DOTA-tyr3-Octreotide0

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