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

TNBC - Triple-Negative Breast Cancer Clinical Trial

— PRISMA  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06059469
• Other study ID #: IJBMNdTNBC
• Status: Recruiting
• Phase: Phase 2
• Start date: May 30, 2022
• Est. completion date: September 2024

Study information

• Verified date: September 2023
• Source: Jules Bordet Institute
• Contact: Géraldine Gebhart, MD
• Phone: 025413095
• Email: geraldine.gebhart[@]hubruxelles.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• TNBC - Triple-Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Jules Bordet Institute

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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