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

Phase 2

Recruiting

• Conditions: TNBC - Triple-Negative Breast Cancer
• Interventions: Diagnostic Test: Ga-PSMA PET/CT

• Registration Number: NCT06059469
• Lead Sponsor: Jules Bordet Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-30
• Status Verified: 2023-09
• Study First Submitted: 2023-09-06
• Study First Submitted QC: 2023-09-26
• Last Update Submitted: 2023-09-26
• Study First Posted: 2023-09-28
• Last Update Posted: 2023-09-28
• Primary Completion: 2024-06
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CT	Ga-PSMA PET/CT	Patients with progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CT

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Institut Jules Bordet; 🇧🇪 Brussels, Belgium