Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-05 @ 4:11 AM
Study NCT ID:
NCT05691894
Status:
UNKNOWN
Last Update Posted:
2023-01-20
First Post:
2023-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tracer Targeting FAP PET Imaging in Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000707753', 'term': '68Ga-FAPI'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-19', 'studyFirstSubmitDate': '2023-01-11', 'studyFirstSubmitQcDate': '2023-01-19', 'lastUpdatePostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of tissue distribution of 18F-FAPI', 'timeFrame': '1 day', 'description': 'Biodistribution of 18F-FAPI evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 18F-PET scans will be reported.'}, {'measure': 'Evaluation of tissue distribution of 68Ga-FAPI', 'timeFrame': '1 day', 'description': 'Biodistribution of 68Ga-FAPI evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 68Ga-PET scans will be reported.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'This is a single arm study to evaluate the safety and biodistribution of tracer targeting FAP PET Imaging in patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients voluntarily signed informed consent;\n2. Age 18-75, male or female;\n3. Patients diagnosed with cancer confirmed by histopathology or cytology;\n4. At least one measurable solid lesion has been examined according RECIST1.1 standard;\n5. ECOG score 0\\~2.\n\nExclusion Criteria:\n\n1. Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;\n2. Patients with systemic or locally severe infections, or other serious coexisting diseases;\n3. Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;\n4. Patients with autoimmune diseases, including rheumatoid arthritis;\n5. Inadequate control of arrhythmias, including atrial fibrillation;\n6. Uncontrolled hypertension;\n7. Patients with allergies or allergies to any component of the imaging agent or antibody;\n8. Patients who cannot undergo PET/CT imaging scan;\n9. Syphilis, HBV, HCV, or HIV positive subjects;\n10. Male and female subjects of reproductive age cannot take effective contraceptive measures;\n11. Pregnant or lactating women;\n12. Patients with a history of mental illness or related conditions;\n13. Other subjects considered unsuitable by researchers.'}, 'identificationModule': {'nctId': 'NCT05691894', 'briefTitle': 'Tracer Targeting FAP PET Imaging in Patients', 'organization': {'class': 'OTHER', 'fullName': 'Affiliated Hospital of Jiangnan University'}, 'officialTitle': 'Tracer Targeting FAP PET Imaging in Patients', 'orgStudyIdInfo': {'id': 'LS2020024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '18F-FAPI', 'interventionNames': ['Drug: 18F-FAPI']}, {'type': 'EXPERIMENTAL', 'label': '68Ga-FAPI', 'interventionNames': ['Drug: 68Ga-FAPI']}], 'interventions': [{'name': '18F-FAPI', 'type': 'DRUG', 'description': 'Patients will receive a tracer dose of 18F (8-10mCi) labelled FAPI', 'armGroupLabels': ['18F-FAPI']}, {'name': '68Ga-FAPI', 'type': 'DRUG', 'description': 'Patients will receive a tracer dose of 68Ga (2-5mCi) labelled FAPI', 'armGroupLabels': ['68Ga-FAPI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '214000', 'city': 'Wuxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chunjing Yu', 'role': 'CONTACT', 'email': 'ycj_wxd1978@163.com', 'phone': '15312238622'}], 'facility': 'Affiliated Hospital of Jiangnan University', 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}], 'centralContacts': [{'name': 'Chunjing Yu', 'role': 'CONTACT', 'email': 'ycj_wxd1978@163.com', 'phone': '15312238622'}], 'overallOfficials': [{'name': 'Chunjing Yu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated Hospital of Jiangnan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Affiliated Hospital of Jiangnan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Chunjing Yu', 'investigatorAffiliation': 'Affiliated Hospital of Jiangnan University'}}}}