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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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2021-01-14

Study results available
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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

DRUG

Satoreotide trizoxetan 5-20μg

Positron emission tomography (PET) imaging agent

DRUG

Satoreotide trizoxetan 30-45μg

Positron emission tomography (PET) imaging agent

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-26
Primary Completion
2019-07-25
Completion
2019-08-05
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Denmark

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03220217 on ClinicalTrials.gov