To Evaluate the Optimal Dose of 68Ga-OPS202 as a PET (Positron Emission Tomography) Imaging Agent in Subjects With Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)
NCT ID: NCT03220217
Last Updated: 2021-01-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
29 participants
INTERVENTIONAL
2017-09-26
2019-08-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
DIAGNOSTIC
SINGLE
Study Groups
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5-20μg/40-80 MBq, 30-45μg/100-140 MBq
Subjects will receive a first intravenous (i.v.) injection of satoreotide trizoxetan with a peptide mass dose range of 5 to 20 μg and a radioactivity dose range 40 to 80 MBq. After 15 to 21 days the subjects will receive a second i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range 100 to 140 MBq.
Satoreotide trizoxetan 5-20μg
Positron emission tomography (PET) imaging agent
Satoreotide trizoxetan 30-45μg
Positron emission tomography (PET) imaging agent
5-20μg/100-140 MBq, 30-45μg/160-200 MBq
Subjects will receive a first i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 5 to 20 μg and a radioactivity dose range 100 to 140 MBq. After 15 to 21 days the subjects will receive a second i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range 160 to 200 MBq.
Satoreotide trizoxetan 5-20μg
Positron emission tomography (PET) imaging agent
Satoreotide trizoxetan 30-45μg
Positron emission tomography (PET) imaging agent
5-20μg/160-200 MBq, 30-45μg/40-80 MBq
Subjects will receive a first i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 5 to 20 μg and a radioactivity dose range 160 to 200 MBq. After 15 to 21 days the subjects will receive a second i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range 40 to 80 MBq.
Satoreotide trizoxetan 5-20μg
Positron emission tomography (PET) imaging agent
Satoreotide trizoxetan 30-45μg
Positron emission tomography (PET) imaging agent
Interventions
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Satoreotide trizoxetan 5-20μg
Positron emission tomography (PET) imaging agent
Satoreotide trizoxetan 30-45μg
Positron emission tomography (PET) imaging agent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed presence of somatostatin receptors (type 2) on technically evaluable tumour lesions documented by a positive Somatostatin Receptor Scan acquired within 6 months prior to screening (Visit 1) and showing minimally two lesions in at least one of the key organs; these images shall be available to be sent to the imaging core lab electronically to ascertain quality and admissibility
* Body weight between 50 kg (110 lb) and 110 kg (243 lb), inclusive
* Adequate bone marrow, liver and renal function
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Exclusion Criteria
* Subject who have received treatment of any somatostatin analogue, including Somatuline® Autogel® /Depot®, Sandostatin® LAR within 28 days, and Sandostatin® within 24 hours prior to first 68Ga-OPS202 administration
* Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide
* Any condition that precludes the proper performance of PET and/or CT scan: a) Subjects who are not able to tolerate the CT contrast agent, b) Subjects with metal implants or arthroplasty, or any other objects that might interfere with the PET and/or CT analysis, c) Subjects unable to raise arms for prolonged imaging purposes, d) Subjects unable to lie still for the entire imaging time, e) Subjects weighing greater than 110 kg (243 lb)
18 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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UCLA Medical Center
Los Angeles, California, United States
Medical University of Innsbruck
Innsbruck, , Austria
University Clinic for Radiology and Nuclear Medicine
Vienna, , Austria
Aarhus University Hospital
Aarhus, , Denmark
Rigshospitalet, University of Copenhagen
Copenhagen, , Denmark
Countries
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References
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Miller CG, Gronbaek H, Virgolini I, Kjaer A, Terve P, Bahri S, Iversen P, Svirydenka H, Rohban T, McEwan S. A novel read methodology to evaluate the optimal dose of 68Ga-satoreotide trizoxetan as a PET imaging agent in patients with gastroenteropancreatic neuroendocrine tumours: a phase II clinical trial. EJNMMI Res. 2021 Sep 6;11(1):84. doi: 10.1186/s13550-021-00819-1.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-004928-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D-FR-01070-002
Identifier Type: -
Identifier Source: org_study_id
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