Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:20 AM
Study NCT ID:
NCT07313033
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-16
First Post:
2025-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
[68]GA-FAPI-46 PET/CT for the Diagnosis of Metastatic Lesions in Patients With Lobular Breast Cancer (ICL).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018275', 'term': 'Carcinoma, Lobular'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients will carry out 2 examinations \\[18F\\]-FDG and \\[68\\]GA-FAPI-46 PET scan and the gold standard will be histology'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-15', 'studyFirstSubmitDate': '2025-12-17', 'studyFirstSubmitQcDate': '2025-12-17', 'lastUpdatePostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients for whom at least one secondary lesion is demonstrated in [68]Ga-FAPI and confirmed by histology, when [18]F-FDG PET/CT is negative', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Average number per patient of lesions demonstrated in [68]Ga-FAPI, not seen in [18F]-FDG', 'timeFrame': '6 weeks', 'description': 'This criteria will be collected when the imaging is read by a nuclear physician.'}, {'measure': 'Number of lesions positive on histology, among the lesions visualized on PET/CT with [68]Ga-FAPI (and in the case of negative histology, identify the differential diagnoses)', 'timeFrame': '6 weeks', 'description': 'This criteria will be collected at the time of publication of the histological report of the suspicious lesion detected.'}, {'measure': 'Evaluate the Positive Predictive Value of [68]Ga-FAPI PET/CT at the patient level, in patients negative on [18]F-FDG PET/CT', 'timeFrame': '6 weeks', 'description': 'This criterion will be collected at the time of publication of the histological report of the suspicious lesion detected.'}, {'measure': 'Analyze the semi-quantitative values of the PET signal by describing the [68Ga]-FAPI lesional SUVs, compared to the vascular and hepatic background', 'timeFrame': '6 weeks', 'description': 'SUVmax bw lesion, SUVmax liver, SUVmax aorta will be collected at the time of reading the imaging by a nuclear physician, for each suspicious lesion'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lobular carcinoma', 'medical imaging at [68]GA-FAPI-46 PET scan', 'oncology', 'gynecology'], 'conditions': ['Lobular Carcinoma', 'Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Invasive squamous cell carcinoma (ISCC) represents 5 to 15% of breast cancers. Despite the rarity of this pathology, the number of patients with Invasive squamous cell carcinoma treated at HCL is significant.\n\nPatients at risk of metastasis are usually referred to the HCL Nuclear Medicine departments to perform positron emission tomography - computed tomography (PET/CT) with \\[18\\]F-FDG as an extension assessment. The investigators know that \\[18\\]F-FDG PET/CT has limited diagnostic performance for assessing the extent of breast cancer with a sensitivity of 66-96% for all histologies combined. For the ISCC, these performances are even lower with average Standard Uptake Value (SUV) values of 3.4 \\[2.8-3.9\\] versus 6.6 \\[4.8-9.7\\] for the others histological types of breast cancer. False negatives in \\[18\\]F-FDG PET/CT are due to an insufficient osteoblastic and immune response in the tumor stroma. Avril \\& al. showed 65.2% false negatives with \\[18\\]F-FDG PET/CT for ISCC. This is why the search for new imaging techniques in this indication is particularly relevant.\n\nTargeting fibroblast activation protein (FAP), a type II membrane glycoprotein belonging to the dipeptidyl peptidase-4 family, is a promising strategy for imaging tumor stroma, particularly in epithelial carcinomas .\n\nThe investigators would like to compare the \\[18\\]F-FDG PET/CT technique currently used to this new emerging modality.\n\nThe investigators hypothesize superior diagnostic performance of \\[68\\]Ga-FAPI PET/CT compared to \\[18\\]F-FDG PET/CT for the assessment of ISCC extension, with a gold standard histological.\n\nThe investigators translate this into the hypothesis of finding 30% of positive FAPI PET when the \\[18F\\]FDG PET/CT is negative or doubtful.\n\nThe advantage of this project and this new imaging modality is to not undertreat patients wrongly classified as non-metastatic. The investigators therefore wish to offer \\[68\\]Ga-FAPI PET/CT to patients with negative \\[18\\]F-FDG PET/CT.\n\nThe FAPICL project constitutes a seed project before a larger structuring study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient (≥18 years old),\n* Beneficiary or entitled to a social security system;\n* Patient having agreed to participate in the study and signed written informed consent;\n* 18F-FDG PET/CT performed as part of the assessment of extension of an infiltrating lobular carcinoma, the result of which is negative or doubtful on at least one lesion.\n\nExclusion Criteria:\n\n* Pregnant, parturient or breastfeeding women. A pregnancy test before inclusion will be carried out for women of childbearing age.\n* Persons deprived of liberty by a judicial or administrative decision\n* People receiving psychiatric care\n* People admitted to a health or social establishment for purposes other than research\n* Adults subject to a legal protection measure (guardianship, curatorship)\n* Subjects participating in another interventional research including an exclusion period still ongoing at inclusion.'}, 'identificationModule': {'nctId': 'NCT07313033', 'acronym': 'FAPI-CL', 'briefTitle': '[68]GA-FAPI-46 PET/CT for the Diagnosis of Metastatic Lesions in Patients With Lobular Breast Cancer (ICL).', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': '[68]GA-FAPI-46 PET/CT for the Diagnosis of Metastatic Lesions in Patients With Lobular Breast Cancer (ICL)', 'orgStudyIdInfo': {'id': '69HCL23_1133'}, 'secondaryIdInfos': [{'id': '2025-524897-40-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'Adult patients with infiltrating lobular carcinomas. Patients must have had a negative or doubtful 18F-FDG PET/CT scan as part of their routine care pathway', 'interventionNames': ['Other: [68]GA-FAPI-46 PET scan']}], 'interventions': [{'name': '[68]GA-FAPI-46 PET scan', 'type': 'OTHER', 'description': 'Realization of a \\[68\\]GA-FAPI-46 PET scan to detect at least one \\[68\\]GA-FAPI positive lesion (confirmed by histology)', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lyon', 'country': 'France', 'contacts': [{'name': 'Nicolas Jacquet-Francillon', 'role': 'CONTACT', 'email': 'nicolas.jacquet-francillon@chu-lyon.fr', 'phone': '+33 4 72 35 69 99'}], 'facility': 'Lyon sud Hospital center - Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Nicolas Jacquet-Francillon', 'role': 'CONTACT', 'email': 'nicolas.jacquet-francillon@chu-lyon.fr', 'phone': '+33 4 72 35 69 99'}, {'name': 'Adeline Mansuy', 'role': 'CONTACT', 'email': 'Adeline.mansuy@chu-lyon.fr', 'phone': '+33 4 72 11 51 70'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}