Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-31 @ 4:48 PM
Study NCT ID:
NCT06945432
Status:
COMPLETED
Last Update Posted:
2025-04-25
First Post:
2025-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing 68Ga-CTR-FAPI and 18F-FDG PET/ CT in Cancer Detection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-18', 'studyFirstSubmitDate': '2025-04-18', 'studyFirstSubmitQcDate': '2025-04-18', 'lastUpdatePostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lesion uptake', 'timeFrame': '1 day', 'description': 'Standardized uptake value (SUV)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tumors', 'PET / CT', 'FDG PET/CT', 'FAPI']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the diagnostic efficacy of 68Ga-CTR-FAPI PET/CT and 18F-FDG PET/CT in various malignant tumors', 'detailedDescription': 'This study recruited malignant tumor patients diagnosed by histopathology and imaging at the Nuclear Medicine Department of Lanzhou University Second Hospital from July 2024 to March 2025. The enrolled patients underwent 68Ga-CTR-FAPI PET/CT and 18F-FDG PET/CT scans within one week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Malignant tumor patients diagnosed by histopathology and imaging', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n(a) Age ≥ 18 years old; (b) Suspected or newly diagnosed malignant tumors, evaluating the therapeutic effect of the tumor, or discovering recurrence/metastasis; (c) Obtain approval from oncologists and agree to undergo 18F-FDG and 68Ga-CTR-FAPI PET/CT scans within one week.\n\nExclusion Criteria:\n\n(a) Pregnancy or lactation period; (b) Claustrophobia. (c) Serious health problems: such as severe heart, liver and kidney dysfunction, diseases that affect the metabolism or clearance of imaging agents.'}, 'identificationModule': {'nctId': 'NCT06945432', 'briefTitle': 'Comparing 68Ga-CTR-FAPI and 18F-FDG PET/ CT in Cancer Detection', 'organization': {'class': 'OTHER', 'fullName': 'Lanzhou University Second Hospital'}, 'officialTitle': 'Comparing 68Ga-CTR-FAPI and 18F-FDG PET/ CT in Cancer Detection', 'orgStudyIdInfo': {'id': 'YZhang'}}, 'contactsLocationsModule': {'locations': [{'zip': '730030', 'city': 'Lanzhou', 'state': 'Gansu', 'country': 'China', 'facility': 'The Second Hospital of Lanzhou University', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lanzhou University Second Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Yuxi Zhang', 'investigatorAffiliation': 'Lanzhou University Second Hospital'}}}}