CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
Satoreotide trizoxetan 5-20μg +1 moredrug
Likely dose
Satoreotide trizoxetan 5-20μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03220217
NCT03220217Phase 2Completed

A Multicentre, Randomised, Dose-confirmation, Factorial Phase II Study to Evaluate the Optimal Dose of 68Ga-OPS202 as a PET Imaging Agent in Subjects With Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)

Ipsen·interventional·Posted Jul 18, 2017·Updated Jan 14, 2021

In Brief

A Phase 2 clinical trial evaluating Satoreotide trizoxetan 5-20μg and Satoreotide trizoxetan 30-45μg for Gastro-Enteropancreatic Neuroendocrine Tumor. Completed, enrolled 29 participants across 5 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Denmark, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJul 18, 2017
Enrollment StartSep 26, 2017
Primary CompletionJul 25, 2019
Study CompletionAug 5, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.0 years ago

Interventions

Satoreotide trizoxetan 5-20μgdrug

Positron emission tomography (PET) imaging agent

Satoreotide trizoxetan 30-45μgdrug

Positron emission tomography (PET) imaging agent