PSMA-PET/CT to Assess the Expression of Specific Membrane Antigen (PSMA) in Patients With Progressive Triple-negative Breast Cancer.
Recruiting · NCT06059469 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Ga-PSMA PET/CT
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed.
- Institut Jules Bordet - Brussels, Belgium