PRISMA: A Single-centre, Prospective Phase II Imaging Study Using PSMA-PET/CT to Assess the Expression of Specific Membrane Antigen (PSMA) in Patients With Progressive Triple-negative Breast Cancer.

Jules Bordet Institute1 site in 1 country20 target enrollmentMay 30, 2022

ConditionsTNBC - Triple-Negative Breast Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: TNBC - Triple-Negative Breast Cancer
Sponsor: Jules Bordet Institute
Enrollment: 20
Locations: 1
Primary Endpoint: Assess PSMA expression in progressive metastatic TNBC patients
Status: Recruiting
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a descriptive, prospective, single centre study. This study will assess PSMA expression via the uptake of radiolabelled PSMA-ligand using PET/CT imaging in mTNBC lesions pre-identified on 18F-FDG PET/CT in order to evaluate the feasibility of molecular radionuclide therapy in refractory mTNBC using the Lutetium-177 radiolabelled PSMA.

Registry

clinicaltrials.gov

Start Date

May 30, 2022

End Date

December 1, 2025

Last Updated

9 months ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Jules Bordet Institute

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Written informed consent in accordance with institutional guidelines and obtained prior to any study procedure
•Women with ≥ 18 years-old
•Eastern Cooperative Oncology Group Performance Status of 0 to 2
•Confirmed diagnosis of progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CT (performed within 2 weeks) or Brain MRI in case of progressive brain metastases (performed within 4 weeks) prior to PSMA PET/CT.
•Radiolabelled PSMA PET/CT has to be performed before the next treatment line initiation

Exclusion Criteria

•Pregnant or lactating patients
•Other active neoplastic disease
•Treatment by another molecule that is the object of investigation within 30 days
•Skin only metastatic disease
•Patients with a significant medical, neuro-psychiatric, or surgical condition, which, in the investigator's opinion, may interfere with completion of the study

Outcomes

Primary Outcomes

Assess PSMA expression in progressive metastatic TNBC patients

Time Frame: once at baseline prior to the start of the new anti cancer treatment

uptake of radiolabelled PSMA-ligand in patients with mTNBC on PET/CT images.

Secondary Outcomes

Assess the concordance between lesions visualized on PSMA PET/CT and 18F-FDG PET/CT images (or brain MRI in case of brain metastases).(once at baseline prior to the start of the new anti cancer treatment)