To Evaluate the Optimal Dose of 68Ga-OPS202 as a PET (Positron Emission Tomography) Imaging Agent in Subjects With Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)

Completed · Phase 2

Conditions studied: Gastro-Enteropancreatic Neuroendocrine Tumor

In brief

The purpose of this clinical research is to confirm the optimal dose of 68Ga-satoreotide trizoxetan (68Ga-IPN01070), formerly 68Ga-OPS202, as a PET imaging agent to be used to detect and localize gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs). 68Ga-IPN01070 is a radiolabelled imaging agent to be used in association with Positron-Emission-Tomography (PET). 68Ga-IPN01070 is made of two main components: 1) IPN01070, an antagonistic somatostatin analogue which binds to the somatostatin receptor (type 2) present on the surface of the tumor cells and 2) Gallium-68, a radioisotope that combined with IPN01070 can be seen in the PET scanner.

Key facts

Study ID

NCT03220217

Run by

Ipsen

People needed

29

Starts

2017-09-26

Expected to finish

2019-08-05

Last updated by the study team

2021-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically confirmed, well differentiated functioning or non-functioning metastatic GEP-NET (Grade I and II as per World Health Organisation classification 2010)
• 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

You may not qualify if…

• Fewer than five lesions in total and more than 25 lesions/organ detected by the previous somatostatin receptor scan in key organs: liver, lymph nodes, bone or lungs
• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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