Ignite Creation Date:
2025-12-17 @ 1:45 PM
Ignite Modification Date:
2025-12-23 @ 6:43 PM
Study NCT ID:
NCT06455761
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-07
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
68Ga-DOTA-NI-FAPI04 PET/CT in Patients With Various Types of Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-07', 'studyFirstSubmitDate': '2024-06-07', 'studyFirstSubmitQcDate': '2024-06-07', 'lastUpdatePostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic value', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'Sensitivity and Specificity of 68Ga-DOTA-NI-FAPI04 in Patients With Various Types of Cancer and comrare it with 68Ga-FAPI/18F-FDG PET/CT.'}], 'secondaryOutcomes': [{'measure': 'SUV of tumors', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'Compare the SUV of tumors between 68Ga-DOTA-NI-FAPI04 PET/CT and 68Ga-FAPI/18F-FDG PET/CT.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tumor']}, 'descriptionModule': {'briefSummary': 'As a novel radiotracer targeting fibroblast activation protein (FAP), 68Ga-DOTA-NI-FAPI04 is a novel agent incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a FAP-targeting. In this study, we observed the diagnostic performance of 68Ga-DOTA-NI-FAPI04 PET/CT in patients with different types of cancer, and compared its imaging results with those of 68Ga-FAPI or 18F-FDG PET/CT.', 'detailedDescription': "Carcinoma-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment, and fibroblast activation protein (FAP), as a specific marker of CAFs, is overexpressed in more than 90% of epithelial malignant tumors' CAFs, with limited expression in normal tissues, making it an appropriate target for various tumors. Currently, several tracers targeting FAP for diagnostic purposes have been developed, such as 68Ga-FAPI-04, 68Ga-FAPI-02, showing high efficacy in tumor staging and restaging. As a novel radiotracer targeting fibroblast activation protein (FAP), 68Ga-DOTA-NI-FAPI04 is a novel agent incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a FAP-targeting. In this study, we observed the diagnostic performance of 68Ga-DOTA-NI-FAPI04 PET/CT in patients with different types of cancer, and compared its imaging results with those of 68Ga-FAPI or 18F-FDG PET/CT."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nVarious solid tumors with available histopathological findings; Signed informed consent.\n\nExclusion Criteria:\n\npregnant or lactational women; who suffered from severe hepatic and renal insufficiency.'}, 'identificationModule': {'nctId': 'NCT06455761', 'briefTitle': '68Ga-DOTA-NI-FAPI04 PET/CT in Patients With Various Types of Cancer', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Fujian Medical University'}, 'officialTitle': '68Ga-DOTA-NI-FAPI04 PET/CT in Patients With Various Types of Cancer', 'orgStudyIdInfo': {'id': 'FirstAHFujian-68Ga-FAPI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '68Ga-DOTA-NI-FAPI04 PET/ CT', 'description': 'Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-DOTA-NI-FAPI04. Tracer doses of 68Ga-DOTA-NI-FAPI04 will be used to detect tumors by PET/CT.', 'interventionNames': ['Drug: 68Ga-DOTA-NI-FAPI04']}, {'type': 'EXPERIMENTAL', 'label': '68Ga-FAPI/18F-FDG PET/ CT', 'description': 'Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-FAPI or 3.7 MBq (0.1 mCi)/Kg 18FFDG. Tracer doses of 68Ga-FAPI/18F-FDG will be used to detect tumors by PET/CT.', 'interventionNames': ['Drug: 68Ga-FAPI/18F-FDG']}], 'interventions': [{'name': '68Ga-DOTA-NI-FAPI04', 'type': 'DRUG', 'description': 'Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-DOTA-NI-FAPI04. Tracer doses of 68Ga-DOTA-NI-FAPI04 will be used to detect tumors by PET/CT.', 'armGroupLabels': ['68Ga-DOTA-NI-FAPI04 PET/ CT']}, {'name': '68Ga-FAPI/18F-FDG', 'type': 'DRUG', 'description': 'Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-FAPI or 3.7 MBq (0.1 mCi)/Kg 18F-FDG. Tracer doses of 68Ga-FAPI/18F-FDG will be used to detect tumors by PET/CT.', 'armGroupLabels': ['68Ga-FAPI/18F-FDG PET/ CT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fuzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weibing Miao, MD', 'role': 'CONTACT', 'email': 'miaoweibing@126.com', 'phone': '+86-0591-87981618'}, {'name': 'Guochang Wang, MD', 'role': 'CONTACT', 'email': 'guochang1007@163.com', 'phone': '+86-0591-87981619'}], 'facility': 'The First Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'centralContacts': [{'name': 'Weibing Miao, MD', 'role': 'CONTACT', 'email': 'miaoweibing@126.com', 'phone': '+86-0591-87981618'}, {'name': 'Guochang Wang, MD', 'role': 'CONTACT', 'email': 'guochang1007@163.com', 'phone': '+86-0591-87981619'}], 'overallOfficials': [{'name': 'Weibing Weibing, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Fujian Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Fujian Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}