Back to resultsPSMA-PET/CT to Assess the Expression of Specific Membrane Antigen (PSMA) in Patients With Progressive Triple-negative Breast Cancer. (PRISMA)
Primary Purpose
TNBC - Triple-Negative Breast Cancer
Status
Recruiting
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Ga-PSMA PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for TNBC - Triple-Negative Breast Cancer
Eligibility Criteria
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
Sites / Locations
- Institut Jules BordetRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CT
Arm Description
Patients with progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CT
Outcomes
Primary Outcome Measures
Assess PSMA expression in progressive metastatic TNBC patients
uptake of radiolabelled PSMA-ligand in patients with mTNBC on PET/CT images.
Secondary Outcome Measures
Assess the concordance between lesions visualized on PSMA PET/CT and 18F-FDG PET/CT images (or brain MRI in case of brain metastases).
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
Full Information
NCT ID
NCT06059469
First Posted
September 6, 2023
Last Updated
September 26, 2023
Sponsor
Jules Bordet Institute
1. Study Identification
Unique Protocol Identification Number
NCT06059469
Brief Title
PSMA-PET/CT to Assess the Expression of Specific Membrane Antigen (PSMA) in Patients With Progressive Triple-negative Breast Cancer.
Acronym
PRISMA
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jules Bordet Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TNBC - Triple-Negative Breast Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CT
Arm Type
Experimental
Arm Description
Patients with progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CT
Intervention Type
Diagnostic Test
Intervention Name(s)
Ga-PSMA PET/CT
Intervention Description
Patient undergo Ga-PSMA PET/CT prior to the start of the new drug treatment
Primary Outcome Measure Information:
Title
Assess PSMA expression in progressive metastatic TNBC patients
Description
uptake of radiolabelled PSMA-ligand in patients with mTNBC on PET/CT images.
Time Frame
once at baseline prior to the start of the new anti cancer treatment
Secondary Outcome Measure Information:
Title
Assess the concordance between lesions visualized on PSMA PET/CT and 18F-FDG PET/CT images (or brain MRI in case of brain metastases).
Description
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
Time Frame
once at baseline prior to the start of the new anti cancer treatment
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women with ≥ 18 years-old
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Géraldine Gebhart, MD
Phone
025413095
Email
geraldine.gebhart@hubruxelles.be
First Name & Middle Initial & Last Name or Official Title & Degree
Loubna Taraji, Ms
Phone
025413781
Email
loubna.taraji@hubruxelles.be
Facility Information:
Facility Name
Institut Jules Bordet
City
Brussels
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loubna Taraji Schiltz
Email
loubna.taraji@hubruxelles.be
12. IPD Sharing Statement
Learn more about this trial
PSMA-PET/CT to Assess the Expression of Specific Membrane Antigen (PSMA) in Patients With Progressive Triple-negative Breast Cancer.
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