Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-01 @ 6:03 PM
Study NCT ID:
NCT06800768
Status:
RECRUITING
Last Update Posted:
2025-01-30
First Post:
2025-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Value of 68Ga-FAPI PET/CT in Detecting Recurrent and Metastatic Lesions in Patients with Thyroid Cancer After Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2030-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-24', 'studyFirstSubmitDate': '2025-01-24', 'studyFirstSubmitQcDate': '2025-01-24', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of recurrent or metastatic thyroid cancer', 'timeFrame': 'Within 1 week after enrollment', 'description': 'The value of 68Ga-FAPI PET/CT in detecting recurrent and metastatic lesions in patients with thyroid cancer after surgery'}], 'secondaryOutcomes': [{'measure': 'Standardized uptake value(SUV)', 'timeFrame': 'Within 1 week after enrollment', 'description': 'SUV of 68Ga-FAPI uptake on PET/CT images for tumor lesions'}, {'measure': 'Disease free survival', 'timeFrame': '3 years', 'description': 'Disease free survival'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thyroid Cancer', '68Ga-FAPI', 'PET/CT'], 'conditions': ['Thyroid Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the value of 68Ga-FAPI PET/CT in detecting recurrent and metastatic lesions in patients with thyroid cancer after surgery.', 'detailedDescription': 'The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo a 68Ga-FAPI PET/CT when recurrence or metastasis is suspected. The imaging response measurements will be compared with follow-up results or histopathological findings as the gold standard.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inpatients and outpatients at Ruijin Hospital who meet the inclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with thyroid cancer who have undergone surgery and are suspected of recurrence or metastasis during clinical evaluation.\n2. Signed and dated informed consent form.\n3. Commitment to comply with research procedures and co-operation in the implementation of the full research process.\n4. Aged 18-80 years old.\n\nExclusion Criteria:\n\n1. Patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.\n2. Intestinal perforation, complete intestinal obstruction.\n3. Pregnant women and women who may be pregnant, women who are breastfeeding.\n4. Non-compliant person.'}, 'identificationModule': {'nctId': 'NCT06800768', 'briefTitle': 'The Value of 68Ga-FAPI PET/CT in Detecting Recurrent and Metastatic Lesions in Patients with Thyroid Cancer After Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'The Value of 68Ga-FAPI PET/CT in Detecting Recurrent and Metastatic Lesions in Patients with Thyroid Cancer After Surgery', 'orgStudyIdInfo': {'id': 'RuijinH 2025-15'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with suspected recurrence or metastasis of thyroid cancer after surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200001', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qinyu Li', 'role': 'CONTACT', 'email': 'lqy10807@rjh.com.cn', 'phone': '15221971915'}], 'facility': 'Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jiajia Hu', 'role': 'CONTACT', 'email': 'jiajiahu@shsmu.edu.cn', 'phone': '13524945287'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy director', 'investigatorFullName': 'Hu Jiajia', 'investigatorAffiliation': 'Ruijin Hospital'}}}}