Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT06059469
Status:
RECRUITING
Last Update Posted:
2025-07-18
First Post:
2023-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PSMA-PET/CT to Assess the Expression of Specific Membrane Antigen (PSMA) in Patients With Progressive Triple-negative Breast Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2023-09-06', 'studyFirstSubmitQcDate': '2023-09-26', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess PSMA expression in progressive metastatic TNBC patients', 'timeFrame': 'once at baseline prior to the start of the new anti cancer treatment', 'description': 'uptake of radiolabelled PSMA-ligand in patients with mTNBC on PET/CT images.'}], 'secondaryOutcomes': [{'measure': 'Assess the concordance between lesions visualized on PSMA PET/CT and 18F-FDG PET/CT images (or brain MRI in case of brain metastases).', 'timeFrame': 'once at baseline prior to the start of the new anti cancer treatment', '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'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['TNBC - Triple-Negative Breast Cancer']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Women with ≥ 18 years-old', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent in accordance with institutional guidelines and obtained prior to any study procedure\n* Women with ≥ 18 years-old\n* Eastern Cooperative Oncology Group Performance Status of 0 to 2\n* 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.\n* Radiolabelled PSMA PET/CT has to be performed before the next treatment line initiation\n\nExclusion Criteria:\n\n* Pregnant or lactating patients\n* Other active neoplastic disease\n* Treatment by another molecule that is the object of investigation within 30 days\n* Skin only metastatic disease\n* Patients with a significant medical, neuro-psychiatric, or surgical condition, which, in the investigator's opinion, may interfere with completion of the study"}, 'identificationModule': {'nctId': 'NCT06059469', 'acronym': 'PRISMA', 'briefTitle': 'PSMA-PET/CT to Assess the Expression of Specific Membrane Antigen (PSMA) in Patients With Progressive Triple-negative Breast Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'Jules Bordet Institute'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'IJBMNdTNBC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CT', 'description': 'Patients with progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CT', 'interventionNames': ['Diagnostic Test: Ga-PSMA PET/CT']}], 'interventions': [{'name': 'Ga-PSMA PET/CT', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patient undergo Ga-PSMA PET/CT prior to the start of the new drug treatment', 'armGroupLabels': ['Patients with progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Loubna Taraji Schiltz', 'role': 'CONTACT', 'email': 'loubna.taraji@hubruxelles.be'}], 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Géraldine Gebhart, MD', 'role': 'CONTACT', 'email': 'geraldine.gebhart@hubruxelles.be', 'phone': '025413095'}, {'name': 'Loubna Taraji, Ms', 'role': 'CONTACT', 'email': 'loubna.taraji@hubruxelles.be', 'phone': '025413781'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jules Bordet Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}