Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-30 @ 8:52 AM
Study NCT ID:
NCT05806333
Status:
UNKNOWN
Last Update Posted:
2023-04-10
First Post:
2023-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
[18F]FAPI PET/CT in Suspicious Focal Liver Lesions Without FDG Avidity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2023-03-08', 'studyFirstSubmitQcDate': '2023-03-28', 'lastUpdatePostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic performance of FAPI PET', 'timeFrame': '1 year', 'description': 'Sensitivity and specificity in detecting liver cancer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Cancer']}, 'descriptionModule': {'briefSummary': 'Fibroblast activation protein (FAP) is a serine protease that belongs to the dipeptidyl peptidase-IV (DPP-IV) family located in fbroblast membranes. FAP is overexpressed in the cancer-associated fbroblasts (CAFs) of 90% of epithelial carcinomas, including primary and metastatic liver cancer. We aim to conduct a prospective study to investigate the diagnostic perfoemance of 18F-FAPI PET/CT in evaluating suspicious liver mass without FDG avidity.', 'detailedDescription': 'Fibroblast activation protein (FAP) is a serine protease that belongs to the dipeptidyl peptidase-IV (DPP-IV) family located in fbroblast membranes. FAP is overexpressed in the cancer-associated fbroblasts (CAFs) of 90% of epithelial carcinomas, including primary and metastatic liver cancer. Therefore, FAP-targeted radiopharmaceuticals can be considered a promising approach for visualizing CAFs. CAFs are crucial components of the tumor stroma, promote the growth of cancer cells, and are associated with poor prognosis. Currently, 18F-labelled fbroblast activation protein inhibitor 18F-FAPI has shown promising diagnostic value in many types of tumors, especially those in which are not avid for 18F-FDF , and several studies have demonstrated that 18F-FAPI PET/CT is superior to 18F-FDG PET/CT for detecting liver cancer and has lower tracer uptake in normal liver tissue. We aim to conduct a prospective study to investigate the diagnostic performance of 18F-FAPI PET/CT in evaluating suspicious liver mass without FDG avidity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with suspected liver malignant lesions based on traditional diagnostic imaging (CT or MRI or ultrasound) and clinical symptoms;\n* patients underwent \\[18F\\]FDG PET/CT with negative findings (suspicious primary and/or metastatic lesions were hypo- or isometabolic on \\[18F\\]FDG PET/CT);\n* patients who agreed to undergo \\[18F\\]FAPI PET/CT scans within 1 week.\n\nExclusion Criteria:\n\n* pregnancy;\n* age\\<18 years old;\n* patients with chemo/radio/targeted therapy before scanning;\n* inability to provide informed consent (signed by participant, parent, or legal representative).'}, 'identificationModule': {'nctId': 'NCT05806333', 'briefTitle': '[18F]FAPI PET/CT in Suspicious Focal Liver Lesions Without FDG Avidity', 'organization': {'class': 'OTHER', 'fullName': 'Jilin University'}, 'officialTitle': 'Diagnostic Performance of [18F]FAPI PET/CT in Suspicious Focal Liver Lesions Without FDG Avidity', 'orgStudyIdInfo': {'id': 'ChinaJapanUH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'suspicious focal liver mass without FDG avidity', 'description': 'Experimental: 18F-FAPI PET/CT Imaging was performed 30-60 minutes after injection of 2-4mci 68Ga-FAPI tracer', 'interventionNames': ['Diagnostic Test: FAPI PET']}], 'interventions': [{'name': 'FAPI PET', 'type': 'DIAGNOSTIC_TEST', 'description': 'Drug: 18F-FAPI 18F-FAPI were injected into the patients before the PET/CT scans', 'armGroupLabels': ['suspicious focal liver mass without FDG avidity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130031', 'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Wei', 'role': 'CONTACT', 'email': 'Weijunsy1949@163.com', 'phone': '+8684995117'}], 'facility': 'China-Japan Union Hospital', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}], 'centralContacts': [{'name': 'Shi Gao [gshi]', 'role': 'CONTACT', 'email': 'Gaoshi@jlu.edu.cn', 'phone': '+86-84995467'}, {'name': 'Ji Bin [jbin]', 'role': 'CONTACT', 'email': 'jibin1983104@163.com', 'phone': '+86-15143066521'}], 'overallOfficials': [{'name': 'Bin Ji', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China-Japan Union Hospital, Jilin University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jilin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PHD', 'investigatorFullName': 'Ji Bin', 'investigatorAffiliation': 'Jilin University'}}}}