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

Sponsor

Jules Bordet Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT06059469

Collaborator

(none)

Enrollment

Location

Arm

27.1

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
TNBC - Triple-Negative Breast Cancer	Diagnostic Test: Ga-PSMA PET/CT	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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.

Actual Study Start Date :

May 30, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Patients with progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CT

Patients with progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CT

Diagnostic Test: Ga-PSMA PET/CT

Patient undergo Ga-PSMA PET/CT prior to the start of the new drug treatment

Outcome Measures

Primary Outcome Measures

Assess PSMA expression in progressive metastatic TNBC patients [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 Outcome Measures

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]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Jules Bordet	Brussels		Belgium

Sponsors and Collaborators

Jules Bordet Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jules Bordet Institute

ClinicalTrials.gov Identifier:

NCT06059469

Other Study ID Numbers:

IJBMNdTNBC

First Posted:

Sep 28, 2023

Last Update Posted:

Sep 28, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Triple Negative Breast Neoplasms

Gallium 68 PSMA-11

Study Results

No Results Posted as of Sep 28, 2023