Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT05392205
Status:
COMPLETED
Last Update Posted:
2023-02-27
First Post:
2022-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comaprison of 68Ga-FAP-2286 and 18F-FDG PET/CT in Patients With Various Types of Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-24', 'studyFirstSubmitDate': '2022-05-22', 'studyFirstSubmitQcDate': '2022-05-22', 'lastUpdatePostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy', 'timeFrame': '90 days', 'description': 'The sensitivity, specificity, and accuracy of 18F-FDG and 68Ga-FAP-2286 PET/CT were calculated and compared to evaluate the diagnostic efficacy.'}], 'secondaryOutcomes': [{'measure': 'Standardized uptake value (SUV)', 'timeFrame': '30 days', 'description': 'Standardized uptake value (SUV) of 18F-FDG and 68Ga-FAP-2286 PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis.'}, {'measure': 'Number of lesions', 'timeFrame': '90 days', 'description': 'The numbers of positive primary and metastatic lesions of 18F-FDG and 68Ga-FAP-2286 PET/CT were recorded by visual interpretation.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tumor', 'Solid', 'Positron-Emission Tomography', 'diagnosis'], 'conditions': ['Tumor, Solid', 'Positron-Emission Tomography']}, 'descriptionModule': {'briefSummary': 'To evaluate the potential usefulness of 68Ga-FAP-2286 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer, and compared with 18F-FDG PET/CT.', 'detailedDescription': 'Subjects with various types of cancer underwent contemporaneous 68Ga-FAP-2286 and 18F-FDG PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of positive tumor lesions of 18F-FDG and 68Ga-FAP-2286 PET/CT were recorded by visual interpretation. The sensitivity, specificity, and accuracy of 68Ga-FAP-2286, 18F-FDG PET/CT were calculated and compared to evaluate the diagnostic accuracy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients (aged 18 years or order);\n* patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);\n* patients who had scheduled both 18F-FDG and 68Ga-FAP-2286 PET/CT scans;\n* patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.\n\nExclusion Criteria:\n\n* patients with non-malignant lesions;\n* patients with pregnancy;\n* the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent;'}, 'identificationModule': {'nctId': 'NCT05392205', 'briefTitle': 'Comaprison of 68Ga-FAP-2286 and 18F-FDG PET/CT in Patients With Various Types of Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Xiamen University'}, 'officialTitle': 'Evaluating the Potential Usefulness of 68Ga-FAP-2286 PET/CT in Patients With Various Types of Cancer and Compared With 18F-FDG PET/CT', 'orgStudyIdInfo': {'id': '2022KY013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '68Ga-FAP-2286', 'description': 'Each subject receives a single intravenous injection of 18F-FDG and 68Ga-FAP-2286, and undergo PET/CT imaging within the specified time.', 'interventionNames': ['Diagnostic Test: 18F-FDG']}], 'interventions': [{'name': '18F-FDG', 'type': 'DIAGNOSTIC_TEST', 'description': 'Each subject receives a single intravenous injection of 18F-FDG and 68Ga-FAP-2286, and undergo PET/CT imaging within the specified time. A part of participants will also undergo additional 68Ga-FAPI-46 PET/CT for comparison.', 'armGroupLabels': ['68Ga-FAP-2286']}]}, 'contactsLocationsModule': {'locations': [{'zip': '361000', 'city': 'Xiamen', 'state': 'Fujian', 'country': 'China', 'facility': 'The First affiliated hospital of xiamen university', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}], 'overallOfficials': [{'name': 'Long Sun, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Affiliated Hospital of Xiamen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Xiamen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}