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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJules Bordet Institute

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Ga-PSMA PET/CT

    Diagnostic test

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Patients with progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Assess PSMA expression in progressive metastatic TNBC patients

uptake of radiolabelled PSMA-ligand in patients with mTNBC on PET/CT images.

Time frame
once at baseline prior to the start of the new anti cancer treatment

Secondary outcomes

1

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

Time frame
once at baseline prior to the start of the new anti cancer treatment

Other outcomes

Sponsors and contacts

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