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Last Updated: October 7, 2022

CLINICAL TRIALS PROFILE FOR GALLIUM DOTATOC GA 68


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All Clinical Trials for GALLIUM DOTATOC GA 68

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01619865 ↗ Safety of 68Ga-DOTA-tyr3-Octreotide PET in Diagnosis of Solid Tumors Completed Sue O'Dorisio Phase 1/Phase 2 2012-02-21 This protocol is designed to test the efficacy of 68Ga-DOTATOC PET/CT in diagnosis, staging, and measurement of response to treatment in patients with somatostatin receptor positive tumors. Goals are to 1) compare this unique PET/CT scan with the current standard of care which is a combination of Octreoscan SPECT (single photon emission tomography) plus a high resolution, contrast enhanced CT; 2) Determine the sensitivity of 68Ga-DOTATOC PET/CT in diagnosis of patients with suspected somatostatin receptor positive tumor; and 3) For those patients who have had recent treatment (e.g., surgery, chemotherapy, targeted therapy such as anti-angiogenics, kinase inhibitors, peptide receptor radiotherapy), this scan will be used to measure response to treatment. These studies will be obtained with the long term goal of submitting a New Drug Application (NDA) for FDA approval of 68Ga-DOTATOC PET/CT in adults and children.
NCT01619865 ↗ Safety of 68Ga-DOTA-tyr3-Octreotide PET in Diagnosis of Solid Tumors Completed University of Iowa Phase 1/Phase 2 2012-02-21 This protocol is designed to test the efficacy of 68Ga-DOTATOC PET/CT in diagnosis, staging, and measurement of response to treatment in patients with somatostatin receptor positive tumors. Goals are to 1) compare this unique PET/CT scan with the current standard of care which is a combination of Octreoscan SPECT (single photon emission tomography) plus a high resolution, contrast enhanced CT; 2) Determine the sensitivity of 68Ga-DOTATOC PET/CT in diagnosis of patients with suspected somatostatin receptor positive tumor; and 3) For those patients who have had recent treatment (e.g., surgery, chemotherapy, targeted therapy such as anti-angiogenics, kinase inhibitors, peptide receptor radiotherapy), this scan will be used to measure response to treatment. These studies will be obtained with the long term goal of submitting a New Drug Application (NDA) for FDA approval of 68Ga-DOTATOC PET/CT in adults and children.
NCT02375464 ↗ Gallium-68 DOTATOC for Management of Neuroendocrine Tumors No longer available Northwell Health 2015-04-01 Gallium-68 DOTATOC is a material used to find neuroendocrine tumors (NETs) using positron emission tomography (PET scan). The material has already been shown to be better than the currently available imaging agents. This study is designed to evaluate the clinical impact of PET CT scanning using this agent in the evaluation and management of patients with NETs.
NCT02419664 ↗ Ga-68-DOTATOC -PET in the Management of Pituitary Tumours Active, not recruiting Sahlgrenska University Hospital, Sweden Phase 3 2015-01-01 Title: Gallium (GA) -68-DOTATOC -PET (positron emission tomography) in the management of pituitary tumours Medical product: Ga-68-DOTATOC in PET/computer tomography (CT) Route of administration: Intravenously Diseases of interest: Pituitary tumours Aim: To study the detection of pituitary tumours with Ga-68-DOTATOC -PET (Ga-PET) and to correlate the tracer expression to somatostatin receptor (sst) occurrence Study design: Prospective non-randomised case-control study with open design with GA-PET before and after pituitary surgery in patients with pituitary tumours Study population: patients with acromegaly (n=10), Cushing's' disease of pituitary origin (n=10), TSH (thyreotropin) producing tumours (TSHomas) (n=5) and non-functioning pituitary adenomas (NFPA) (n=20) Number of patients: 45 Inclusion criteria: Adult man or woman (over 18 years) and na├»ve, unoperated pituitary tumour with growth hormone (GH) or adrenocorticotrophic hormone (ACTH)) or TSH production or NFPA without treatment with somatostatin analogues (SSA) or dopamine agonists. Exclusion criteria: Patient who may not attend to the protocol according to the investigators opinion. Pregnancy or lactating. Isolated prolactin producing tumours. Overproduction of gonadotropins. Carcinoids ie ectopic corticotrophin realising factor (CRF) production. Known or suspected allergy to the trial product or related products. Controls: Adult patients with Thyroid associated ophthalmopathy (TAO) before iv steroid infusion (part of another study see this protocol)- Study variables: Tumour detection, Tracer uptake as Standardised uptake value (SUV) max (SUVmax), SUV hotspot and SUV mean in regions of interests (ROIs) Time schedule: Recruitment of patients 2015-2017. Study termination 3 years later
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for GALLIUM DOTATOC GA 68

Condition Name

Condition Name for GALLIUM DOTATOC GA 68
Intervention Trials
Neuroendocrine Tumors 3
Meningioma 1
Metastatic Well Differentiated Neuroendocrine Neoplasm 1
Multiple Endocrine Neoplasia Type 1 1
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Condition MeSH

Condition MeSH for GALLIUM DOTATOC GA 68
Intervention Trials
Neuroendocrine Tumors 4
Carcinoid Tumor 2
Neoplasms 2
Medulloblastoma 1
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Clinical Trial Locations for GALLIUM DOTATOC GA 68

Trials by Country

Trials by Country for GALLIUM DOTATOC GA 68
Location Trials
United States 2
Sweden 1
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Trials by US State

Trials by US State for GALLIUM DOTATOC GA 68
Location Trials
Texas 1
Iowa 1
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Clinical Trial Progress for GALLIUM DOTATOC GA 68

Clinical Trial Phase

Clinical Trial Phase for GALLIUM DOTATOC GA 68
Clinical Trial Phase Trials
Phase 3 2
Phase 1/Phase 2 1
Early Phase 1 1
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Clinical Trial Status

Clinical Trial Status for GALLIUM DOTATOC GA 68
Clinical Trial Phase Trials
Completed 2
No longer available 1
Terminated 1
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Clinical Trial Sponsors for GALLIUM DOTATOC GA 68

Sponsor Name

Sponsor Name for GALLIUM DOTATOC GA 68
Sponsor Trials
Charito Love 1
Sue O'Dorisio 1
University of Iowa 1
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Sponsor Type

Sponsor Type for GALLIUM DOTATOC GA 68
Sponsor Trials
Other 9
NIH 1
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