About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Ga-PSMA PET/CT
Diagnostic testPatient undergo Ga-PSMA PET/CT prior to the start of the new drug treatment
Treatment groups
Trial outcomes
Primary outcomes
Assess PSMA expression in progressive metastatic TNBC patients
uptake of radiolabelled PSMA-ligand in patients with mTNBC on PET/CT images.
Secondary outcomes
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
Sponsors and contacts
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