Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT05003427
Status:
UNKNOWN
Last Update Posted:
2022-10-28
First Post:
2021-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
68Ga-FAPI-04 PET/CT for the Detection of Oral Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009062', 'term': 'Mouth Neoplasms'}], 'ancestors': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000707753', 'term': '68Ga-FAPI'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-26', 'studyFirstSubmitDate': '2021-08-06', 'studyFirstSubmitQcDate': '2021-08-06', 'lastUpdatePostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic performance1', 'timeFrame': '1 year', 'description': 'comparing the SUV and number of Oral cancer or metastasis detected by 68Ga-FAPI-04 and 18F-FDG PET/CT'}, {'measure': 'Diagnostic performance2', 'timeFrame': '1 year', 'description': 'comparing the SUV and number of Oral cancer or metastasis detected by 68Ga-FAPI-04 and 18F-FDG PET/CT'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PET/CT', 'FAPI'], 'conditions': ['Oral Carcinoma']}, 'descriptionModule': {'briefSummary': 'FAPI is a fibroblast activation protein inhibitor and 68Ga-FAPI-04 is a potential new imaging agent for imaging of carcinoma. 68Ga-FAPI-04 PET/CT is helpful to clarify the benign, malignant and invasive range of the oral carcinoma, locate and qualitatively diagnose the tumor, and make early diagnosis and restaging of recurrent tumor.', 'detailedDescription': 'Sometimes, the traditional 18F-FDG PET/CT diagnosis of head and neck tumors mistakenly diagnosed inflammatory lymph nodes as metastatic lymph nodes, resulting in false positive results. Fibroblast activation protein (FAP) is a serine peptidase on the surface of tumor associated fibroblasts. It plays an important role in promoting the growth, invasion, metastasis and immunosuppression of tumor cells. FAPI is a fibroblast activation protein inhibitor and 68Ga-FAPI-04 is a potential new imaging agent for imaging of carcinoma. 68Ga-FAPI-04 PET/CT is helpful to clarify the benign, malignant and invasive range of the oral carcinoma, locate and qualitatively diagnose the tumor, and make early diagnosis and restaging of recurrent tumor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients in suspicion of oral carcinoma,\n* 68Ga-FAPI-04 and 18F-FDG PET/CT within 2 week;\n* being able to provide basic information and sign the written informed consent form.\n\nExclusion Criteria:\n\n* claustrophobia,\n* pregnancy,\n* breastfeeding,\n* kidney or liver failure,\n* inability to fulfill the study.'}, 'identificationModule': {'nctId': 'NCT05003427', 'briefTitle': '68Ga-FAPI-04 PET/CT for the Detection of Oral Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': '68Ga-FAPI-04 PET/CT for the Detection of Oral Carcinoma', 'orgStudyIdInfo': {'id': 'PekingUMCH-OralFAP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '68Ga-FAPI-04 PET/CT', 'description': 'The patients were injected with 55.5-148 MBq (1.5-4mCi) of 68Ga-FAPI-04 in one dose intravenously and underwent SPECT/CT scan 30-90 min later.', 'interventionNames': ['Drug: 68Ga-FAPI-04']}], 'interventions': [{'name': '68Ga-FAPI-04', 'type': 'DRUG', 'description': '68Ga-FAPI-04 were injected into the patients before the PET/CT scans', 'armGroupLabels': ['68Ga-FAPI-04 PET/CT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Rongxi Wang', 'role': 'CONTACT', 'email': 'pumch_jacobwong@163.com', 'phone': '+8619800370331'}], 'facility': 'Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Rongxi Wang', 'role': 'CONTACT', 'email': 'pumch_jacobwong@163.com', 'phone': '+8619800370331'}, {'name': 'Zhaohui Zhu, MD', 'role': 'CONTACT', 'email': '13611093752@163.com', 'phone': '13611093752'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}