Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2026-01-03 @ 6:22 PM
Study NCT ID:
NCT06359795
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring the Value of 18F-AlF-FAPI PET/CT in Assessing the Activity of Thyroid Eye Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D049970', 'term': 'Graves Ophthalmopathy'}], 'ancestors': [{'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006111', 'term': 'Graves Disease'}, {'id': 'D005094', 'term': 'Exophthalmos'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006042', 'term': 'Goiter'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-07', 'studyFirstSubmitDate': '2024-04-07', 'studyFirstSubmitQcDate': '2024-04-07', 'lastUpdatePostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'The accuracy of 18F-AlF-FAPI PET/CT in assessing the activity of TED.'}], 'secondaryOutcomes': [{'measure': 'The value to predict therapy response', 'timeFrame': 'through study completion, an average of 12 months', 'description': 'The changes of SUV metrics on 18F-AlF-FAPI PET/CT to predict therapy response'}, {'measure': 'Diagnostic accuracy comparison', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'Comparing the diagnostic accuracy in assessing the activity of TED activity between 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT.'}, {'measure': 'FAPI expression and SUV metrics', 'timeFrame': 'through study completion, an average of 12 months', 'description': 'Correlation between SUV metrics on PET and FAPI expression in patients with surgery.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thyroid Eye Disease']}, 'descriptionModule': {'briefSummary': 'FAPI PET has been developed as a promising approach for the evaluation of fibroinflammatory, such as in inflammatory bowel disease. This prospective study aims to explore the value of 18F-AlF-FAPI PET/CT in assessing the activity of Thyroid Eye Disease (TED) and investigate whether FAPI PET/CT may be superior to 99mTc-DTPA SPECT/CT for the diagnosis, therapy response assessment, and follow-up of TED.', 'detailedDescription': 'Subjects with TED underwent 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT for activity assessment within a 10-day period. On 18F-AlF-FAPI PET/CT, uptake in the extraocular muscles was quantified using SUV metrics and target-to-background ratio. On 99mTc-DTPA SPECT/CT, uptake in the extraocular muscles was semi-quantified using the uptake ratio. Activity of TED was determined through comprehensive clinical data. The correlation between SUV metrics and activity status was calculated to explore the value of 18F-AlF-FAPI PET/CT in assessing TED activity. The diagnostic accuracy of 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT in assessing TED activity was compared. Additionally, the correlation of changes in SUV metrics and therapy response will be calculated to explore the value of 18F-AlF-FAPI PET/CT in therapy response assessment of TED.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. Patients diagnosed with TED;\n3. Complete understanding and voluntary participation in this study, with the signing of an informed consent form.\n\nExclusion Criteria:\n\n1. Severe liver or kidney dysfunction;\n2. Inability to maintain a supine position for 5 minutes to cooperate with the examination;\n3. Suffering from claustrophobia or other psychiatric disorders;\n4. Patients planning pregnancy or in the prenatal or lactation period;\n5. Other conditions deemed unsuitable for participation in the trial by the investigator.'}, 'identificationModule': {'nctId': 'NCT06359795', 'briefTitle': 'Exploring the Value of 18F-AlF-FAPI PET/CT in Assessing the Activity of Thyroid Eye Disease', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Exploring the Value of 18F-AlF-FAPI PET/CT in Assessing the Activity of Thyroid Eye Disease', 'orgStudyIdInfo': {'id': 'FAPI-TED'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental arm', 'description': 'Patients with TED will be recruited in the study.\n\nInterventions:\n\nDiagnostic Test: 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT.', 'interventionNames': ['Diagnostic Test: 18F-AlF-FAPI PET/CT, 99mTc-DTPA SPECT/CT']}], 'interventions': [{'name': '18F-AlF-FAPI PET/CT, 99mTc-DTPA SPECT/CT', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients underwent 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT scans within 10 days.', 'armGroupLabels': ['Experimental arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hui Li, Dr.', 'role': 'CONTACT', 'email': 'huilee1990@163.com', 'phone': '86-13121136769'}, {'name': 'Lingge Suo, Dr.', 'role': 'CONTACT', 'email': 'suolingge_1019@126.com', 'phone': '86-010-82264935'}, {'name': 'Hui Li, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dept. of Nuclear Medicine, Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Hui Li, Dr.', 'role': 'CONTACT', 'email': 'huilee1990@163.com', 'phone': '86-13121136769'}, {'name': 'Lingge Suo, Dr.', 'role': 'CONTACT', 'email': 'suolingge_1019@126.com', 'phone': '86-010-82264935'}], 'overallOfficials': [{'name': 'Hui Li, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}