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
NCT03697551 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2020-09-07
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
- DRUG
-
Satoreotide trizoxetan
Subjects 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.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Ipsen Medical Director · Ipsen
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-10-22
- Primary Completion
- 2019-02-06
- Completion
- 2019-02-06
Countries
- Austria
Study Locations
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