PSMA-PET/CT to Assess the Expression of Specific Membrane Antigen (PSMA) in Patients With Progressive Triple-negative Breast Cancer.

Study 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.

Official Title
-----------------
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.

Conditions
-----------------
TNBC - Triple-Negative Breast Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Ga-PSMA PET/CT


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CT<br>Patients with progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CT | Diagnostic Test: Ga-PSMA PET/CT<br>* Patient undergo Ga-PSMA PET/CT prior to the start of the new drug treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess PSMA expression in progressive metastatic TNBC patients | uptake of radiolabelled PSMA-ligand in patients with mTNBC on PET/CT images. | once at baseline prior to the start of the new anti cancer treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the concordance between lesions visualized on PSMA PET/CT and 18F-FDG PET/CT images (or brain MRI in case of brain metastases). | Matching between FDG and PSMA-labelled radiotracers uptake: on PSMA PET/CT and 18F-FDG PET/CT images, each lesion will be identified and faced with the other images. Each imaging pair will be classified as complete match, partial match or no match between the different types of imaging | once at baseline prior to the start of the new anti cancer treatment |