Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT06335069
Status:
RECRUITING
Last Update Posted:
2025-09-24
First Post:
2024-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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', 'interventionModelDescription': 'Single-group, single-center pilot study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2024-03-11', 'studyFirstSubmitQcDate': '2024-03-21', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'To provide preliminary estimates of the proportion of 68Ga-FAPI-46-positive and 18F-FDG-positive lesions confirmed as true positives and false positives verified by a histological biopsy (gold standard) in patients with ER+ breast cancer.', 'timeFrame': 'Patients will be followed from diagnosis until the additional imaging exams are performed, within 20 working days both PET exams will be performed.', 'description': 'The proportion of 68Ga-FAPI-46-positive lesions and the proportion of 18F-FDG-positive lesions confirmed as true positives or false positives (verified by a biopsy, the gold standard)'}, {'measure': 'To investigate the differences in accuracy between 68Ga-FAPI-46 PET/CT versus 68Ga-FAPI-46 PET/MRI.', 'timeFrame': 'Patients will be followed from diagnosis until the additional imaging exams are performed, within 20 working days both PET exams will be performed.', 'description': 'Diagnostic performance will be compared between both exams (i.e. 68Ga-FAPI-46 PET/CT and 68Ga-FAPI-46 PET/MRI.'}], 'primaryOutcomes': [{'measure': 'To determine essential input parameters for an adequate sample size calculation for a diagnostic study that compares the diagnostic accuracy of 18F-FDG and 68Ga-FAPI-46 as PET tracer in patients with ER+ breast cancer.', 'timeFrame': 'Patients will be followed from diagnosis until the additional imaging exams are performed, within 20 working days both PET exams will be performed.', 'description': 'To investigate the proportion of discordant pairs: the number of lesions detected on 18F-FDG PET but not on 68Ga-FAPI-46 PET and the number of lesions detected on 68Ga-FAPI-46 PET but not on 18F-FDG PET.'}], 'secondaryOutcomes': [{'measure': 'To explore the feasibility of taking biopsies in test-positive patients.', 'timeFrame': 'Patients will be followed from diagnosis until the additional imaging exams are performed, within 20 working days both PET exams will be performed.', 'description': 'The proportion of 68Ga-FAPI-46-positive 18F-FDG-negative lesions for which performing a biopsy is not feasible.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['68Ga-FAPI-46', 'ER+ breast cancer', 'PET/CT', 'PET/MRI'], 'conditions': ['Breast Cancer', 'Breast Neoplasms', 'Breast Diseases']}, 'descriptionModule': {'briefSummary': 'The extent of breast cancer is an important prognostic factor in patients diagnosed with this disease. Therefore, adequate staging at diagnosis is a requisite for optimal treatment. In all patients diagnosed with locally advanced breast cancer (LABC), distant staging using 18F-FDG PET/CT is recommended. However, the degree of metabolic uptake in the primary breast tumor is significantly lower in the ER+ subtype compared to HER2+ and triple negative breast cancer (TNBC). As a consequence, a suboptimal 18F-FDG uptake in ER+ breast cancer patients can potentially lead to missed distant metastases. Fibroblast-activating protein inhibitor (FAPI) is a recently developed radiotracer that binds to FAP, a stromal antigen overexpressed in more than 90% of epithelial-derived tumors and their metastases. Previous studies all show 68Ga-FAPI PET/CT to have a higher detection rate compared to 18F-FDG PET/CT. However, all previous studies were performed without considering breast cancer subtype. If the metabolic uptake by 68Ga-FAPI-46 is higher in ER+ breast cancer patients, more lesions will be detected, resulting in a more appropriate treatment for these patients. Therefore, in this pilot study, the investigators aim to compare the diagnostic performance of 18F-FDG with 68Ga-FAPI-46 as PET-tracer in ER+ breast cancer patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Only females are eligible to participate in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patient with histopathologically proven ER+ breast cancer.\n* Diagnosed with locally advanced (primary tumor \\>5 cm and/or presence of axillary lymph node metastases) or recurrent breast cancer, or metastatic breast cancer for which 18F-FDG PET/CT or 18F-FDG PET/MRI staging is performed.\n* Willing and able to undergo the study procedures.\n* Has personally provided written informed consent.\n\nExclusion Criteria:\n\n* Age \\<18\n* Pregnancy\n* Patients with secondary malignancies (except non-melanoma skin cancer)\n* No 18F-FDG PET/CT or 18F-FDG PET/MRI scan.\n* Contra-indications for PET/MRI such as pacemaker, aneurysm clips, metallic device in their body, severe claustrophobia, and severe obesity\n* Chronic inflammatory disease such as rheumatoid arthritis.\n* Patients with severe hepatic or renal impairment (eGFR ≤45mL/min/1.73m²)\n* Inability to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT06335069', 'briefTitle': '18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': '18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer - a Pilot Study.', 'orgStudyIdInfo': {'id': '2023-508066-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Additional 68Ga-FAPI-46 PET/CT and PET/MRI exam', 'description': 'All participating patients will undergo an additional 68Ga-FAPI- 46 PET/CT and 68Ga-FAPI-46 PET/MRI scan prior to their breast cancer treatment.', 'interventionNames': ['Diagnostic Test: 68Ga-FAPI-46 PET/CT and 68Ga-FAPI-46 PET/MRI']}], 'interventions': [{'name': '68Ga-FAPI-46 PET/CT and 68Ga-FAPI-46 PET/MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'All participating patients will undergo an additional 68Ga-FAPI- 46 PET/CT and 68Ga-FAPI-46 PET/MRI scan prior to their breast cancer treatment.', 'armGroupLabels': ['Additional 68Ga-FAPI-46 PET/CT and PET/MRI exam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5800', 'city': 'Maastricht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Thiemo JA van Nijnatten, MD, PhD', 'role': 'CONTACT', 'email': 'thiemo.nijnatten@mumc.nl'}], 'facility': 'Maastricht University Medical Center+', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'centralContacts': [{'name': 'Thiemo JA van Nijnatten, MD, PhD', 'role': 'CONTACT', 'email': 'thiemo.nijnatten@mumc.nl', 'phone': '+31433876910'}, {'name': 'Lisa EHW Duijx, MSc', 'role': 'CONTACT', 'email': 'lisa.duijx@mumc.nl', 'phone': '+31639289798'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}