TNBC - Triple-Negative Breast Cancer
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTGa-PSMA PET/CT
Patient undergo Ga-PSMA PET/CT prior to the start of the new drug treatment
Sponsors
Jules Bordet Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess PSMA expression in progressive metastatic TNBC patients | once at baseline prior to the start of the new anti cancer treatment | uptake of radiolabelled PSMA-ligand in patients with mTNBC on PET/CT images. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess the concordance between lesions visualized on PSMA PET/CT and 18F-FDG PET/CT images (or brain MRI in case of brain metastases). | once at baseline prior to the start of the new anti cancer treatment | 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 |
Countries
Belgium
Contacts
Primary ContactGéraldine Gebhart, MD
Backup ContactLoubna Taraji, Ms
Outcome results
None listed