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Clinical Trial · NCT06059469
PSMA-PET/CT to Assess the Expression of Specific Membrane Antigen (PSMA) in Patients With Progressive Triple-negative Breast Cancer.
Overview
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.
Sponsor
Jules Bordet Institute
Phase
Phase 2
Contacts
Géraldine Gebhart, MD (CONTACT)
geraldine.gebhart@hubruxelles.be
025413095
Loubna Taraji, Ms (CONTACT)
loubna.taraji@hubruxelles.be
025413781
ClinicalTrials.gov
NCT06059469Drug / Compound
PSMA-ligand
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- PSMA
Ligand Class: Small Molecules
Eligibility
Inclusion
- Radiolabelled PSMA PET/CT has to be performed before the next treatment line initiation
- 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.
Exclusion
- Pregnant or lactating patients
- Other active neoplastic disease
- Patients with a significant medical, neuro-psychiatric, or surgical condition, which, in the investigator's opinion, may interfere with completion of the study
- Treatment by another molecule that is the object of investigation within 30 days
- Skin only metastatic disease
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