Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2026-02-28 @ 12:03 AM
Study NCT ID:
NCT05036759
Status:
UNKNOWN
Last Update Posted:
2021-09-08
First Post:
2021-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
68Ga-FAPI PET/MR for Atherosclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular 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', 'interventionModelDescription': '68Ga-FAPI PET/MR'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2023-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-06', 'studyFirstSubmitDate': '2021-08-30', 'studyFirstSubmitQcDate': '2021-09-06', 'lastUpdatePostDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic performance', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Diagnostic performance of 68Ga-FAPI PET/MR for intracranial or carotid atherosclerosis'}], 'secondaryOutcomes': [{'measure': 'SUVmax', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'The difference of SUVmax between asymptomatic and symptomatic atherosclerotic patients'}, {'measure': 'FAPI expression', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'The correlation of SUVmax and pathological FAPI expression'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atherosclerosis', '68Ga-FAPI', 'PET/MR'], 'conditions': ['Atherosclerosis']}, 'descriptionModule': {'briefSummary': 'A thin-cap fibroatheroma with a large necrotic core and macrophage infiltration marks the vulnerable plaque. Fibroblast activating protein (FAP) is an active serine protease, which can degrade type I collagen, potentially thinning the fibrous cap. Thus we speculate that atherosclerotic plaque could be imaged with 68Ga-FAPI PET/MR.', 'detailedDescription': 'A thin-cap fibroatheroma with a large necrotic core and macrophage infiltration marks the vulnerable plaque. Fibroblast activating protein (FAP) is an active serine protease, which can degrade type I collagen, potentially thinning the fibrous cap. Previous ex vivo analysis of human aortic atheromata revealed that FAP was expressed in atherosclerotic plaques, and higher FAP expression was detected in thin fibrous caps than thick caps. Constitutive Fap deletion in atherosclerosis-prone mice models could reduce plaque formation and improve plaque stability with increased fibrous cap thickness. Thus we speculate that atherosclerotic plaque could be imaged with 68Ga-FAPI PET/MR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* intracranial or carotid atherosclerosis patients\n* signed informed consent\n\nExclusion Criteria:\n\n* pregnancy, breastfeeding\n* contradictions of MRI\n* unstable vital signs'}, 'identificationModule': {'nctId': 'NCT05036759', 'briefTitle': '68Ga-FAPI PET/MR for Atherosclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': '68Ga-FAPI PET/MR for Intracranial and Carotid Atherosclerosis', 'orgStudyIdInfo': {'id': 'PUMCH-FAPI-PET/MR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '68Ga-FAPI, PET/MR', 'description': 'inject 68Ga-FAPIļ¼and then perform PET/MR', 'interventionNames': ['Drug: 68Ga-FAPI']}], 'interventions': [{'name': '68Ga-FAPI', 'type': 'DRUG', 'otherNames': ['68Ga-fibroblast activating protein inhibitors'], 'description': 'intravenously injected with 68Ga-FAPI', 'armGroupLabels': ['68Ga-FAPI, PET/MR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100005', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Huo', 'role': 'CONTACT', 'email': 'huoli@pumch.cn', 'phone': '86-10-69155513'}, {'name': 'Qiao Yang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Meiqi Wu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Li Huo, M.D.', 'role': 'CONTACT', 'email': 'huoli@pumch.cn', 'phone': '86-10-69155537'}], 'overallOfficials': [{'name': 'Qiao Yang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}, {'name': 'Meiqi Wu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}