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Taking people in BelgiumPhase 2

Imaging study checks PSMA protein in progressive triple-negative breast cancer

Tests a PSMA imaging scan in adults with progressive triple-negative breast cancer.

Plain-language title generated from the registry record
Registry title: PSMA-PET/CT to Assess the Expression of Specific Membrane Antigen (PSMA) in Patients With Progressive Triple-negative Breast Cancer.

Key facts

Where
Brussels, BelgiumSee the site
Phase
Phase 2

Where in Belgium

  • Institut Jules BordetBrussels, BelgiumTaking people

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Trial details

Who runs it
Jules Bordet Institute
Trial code
NCT06059469
Record updated
18 July 2025
Original description
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.Read full original descriptionShow less

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.

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.

Inclusion: 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: Other active neoplastic disease; 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; Pregnant or lactating patients; Treatment by another molecule that is the object of investigation within 30 days.

ClinicalTrials.gov NCT06059469