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)

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastro-Enteropancreatic Neuroendocrine Tumor

Interventions

Type	Name	Description
DRUG	Satoreotide trizoxetan 5-20μg	Positron emission tomography (PET) imaging agent
DRUG	Satoreotide trizoxetan 30-45μg	Positron emission tomography (PET) imaging agent

Timeline

• Start date: 2017-09-26
• Primary completion: 2019-07-25
• Completion: 2019-08-05
• First posted: 2017-07-18
• Last updated: 2021-01-14
• Results posted: 2021-01-14

Locations

5 sites across 3 countries: United States, Austria, Denmark

Regulatory

• FDA-regulated drug study