NCT06059469RecruitingPhase 2
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.
Source: ClinicalTrials.gov · Last updated 18 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 6 Sept 2023
- Start date
- 30 May 2022
- Primary completion date
- 2 Jun 2025
- Lead sponsor
- Jules Bordet Institute
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT06059469
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 30 May 2022 to the primary completion date, 2 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Pregnant or lactating patients
- Treatment by another molecule that is the object of investigation within 30 days
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Jules Bordet Coordinator of this site? Confirm its status | Brussels | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.