RecruitingPhase 2NCT06059469

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

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.


Sponsor

Jules Bordet Institute

Enrollment

20 participants

Start Date

May 30, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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

Interventions

DIAGNOSTIC_TESTGa-PSMA PET/CT

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


Locations(1)

Institut Jules Bordet

Brussels, Belgium

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NCT06059469


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