Clinical Trials Directory

Trials / Terminated

TerminatedNCT03697551

Define the Optimal Uptake Time of 68Ga-OPS202 When Used as a PET (Positron Emission Tomography) Imaging Agent in Subjects With Newly Diagnosed Breast Cancer

A Non-Randomised Phase II Study to Evaluate the Optimal Uptake Time of 68GA-OPS202 as a sstr2 Positive PET Imaging Agent in Subjects With Newly Diagnosed Breast Cancer

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
4 (actual)
Sponsor
Ipsen · Industry
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this clinical research is to define the optimal uptake time of 68Ga-OPS202 as a PET imaging agent to be used to detect and localize breast cancer somatostatin receptor subtype 2 (SSTR2) positive lesions. 68Ga-OPS202 is a radiolabelled imaging agent to be used in association with PET. 68Ga-OPS202 is made of two main components: 1) OPS202, 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 OPS202, can be seen in the PET scanner.

Conditions

Interventions

TypeNameDescription
DRUGSatoreotide trizoxetanSubjects will receive a single dose of Satoreotide trizoxetan consisting of a peptide mass up to 45 μg, with a radioactivity range of 150-200 MBq. Satoreotide trizoxetan is intended for diagnostic use as a Positron emission tomography/computed tomography (PET/CT) tracer for the imaging of tumours expressing SSTR2.

Timeline

Start date
2018-10-22
Primary completion
2019-02-06
Completion
2019-02-06
First posted
2018-10-05
Last updated
2020-09-07
Results posted
2020-09-07

Locations

1 site across 1 country: Austria

Source: ClinicalTrials.gov record NCT03697551. Inclusion in this directory is not an endorsement.