drugset / Trial / NCT03220217

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

NCT03220217 ↗

Phase 2 Completed 29 enrolled Ipsen
RandomizedFactorialSingle-blindDiagnostic

Summary

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.

Timeline

Start
2017-09-26
Primary completion
2019-07-25
Completion
2019-08-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Satoreotide trizoxetan Diagnostic / imaging agent — Intravenous