Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT04507932
Status:
UNKNOWN
Last Update Posted:
2021-01-26
First Post:
2020-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characterizing Inflammatory Bowel Disease With 68Ga-FAPI PET/CT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal 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': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-24', 'studyFirstSubmitDate': '2020-08-07', 'studyFirstSubmitQcDate': '2020-08-07', 'lastUpdatePostDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic value', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Sensitivity and Specificity of 68Ga-FAPI PET/CT for inflammatory bowel disease in comparison with 18F-FDG PET/CT'}], 'secondaryOutcomes': [{'measure': 'Metabolic parameters', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Total Lesion Glycolysis (TLG) of bowel lesions are measured on 68Ga-FAPI PET/CT.'}, {'measure': 'FAPI expression and SUV', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Correlation between FAPI expression and SUV in PET'}, {'measure': 'Disease burden assessement', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Correlation between Total Lesion Glycolysis (TLG) of bowel lesions assessed on 68Ga-FAPI PET/CT and clinical parameters for inflammatory bowel disease'}, {'measure': 'therapy response', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Decrease of Total Lesion Glycolysis (TLG) on 68Ga-FAPI PET/CT after therapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Disease']}, 'referencesModule': {'references': [{'pmid': '33247327', 'type': 'DERIVED', 'citation': "Luo Y, Pan Q, Xu H, Zhang R, Li J, Li F. Active uptake of 68Ga-FAPI in Crohn's disease but not in ulcerative colitis. Eur J Nucl Med Mol Imaging. 2021 May;48(5):1682-1683. doi: 10.1007/s00259-020-05129-7. Epub 2020 Nov 27. No abstract available."}]}, 'descriptionModule': {'briefSummary': '68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation,such as inflammatory bowel disease. And it might be more sensitive than FDG in detecting a certain type of inflammations according to our preliminary research. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment and follow-up of inflammatory bowel disease than 18F-FDG PET/CT.', 'detailedDescription': "Inflammatory bowel disease (IBD) is comprised of two major disorders: ulcerative colitis (UC) and Crohn's disease(CD).CD is an autoimmune condition resulting in chronic gut inflammation that can be complicated by intestinal fibrosis and stricture formation. Ulcerative colitis is characterized by recurring episodes of inflammation limited to the mucosal layer of the colon. It commonly involves the rectum and may extend in a proximal and continuous fashion to involve other parts of the colon. Studies identified FAP to be overexpressed in uninflamed strictures compared with nonstrictured colonic regions in biopsies taken from Crohn's disease patients. But preliminary studies showed FAP was not overexpressed in colonic biopsies taken from healthy individuals or individuals with ulcerative colitis.68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and inflammation. Recently we have published an article of the application of 68Ga-FAPI in IgG4-related disease which showed it was more sensitive than FDG in detecting a certain type of inflammations. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment and follow-up of IBD than 18F-FDG PET/CT."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* suspected or confirmed untreated inflammatory bowel disease patients;\n* 18F-FDG PET/CT within two weeks;\n* signed written consent.\n\nExclusion Criteria:\n\n* pregnancy;\n* breastfeeding;\n* known allergy against FAPI\n* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.'}, 'identificationModule': {'nctId': 'NCT04507932', 'briefTitle': 'Characterizing Inflammatory Bowel Disease With 68Ga-FAPI PET/CT', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Characterizing Inflammatory Bowel Disease With 68Ga-FAPI PET/CT', 'orgStudyIdInfo': {'id': 'PekingUMCHFAPIIBD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '68Ga-FAPI, PET/CT', 'description': 'Inject 68Ga-FAPI and then perform PET/CT scan.', 'interventionNames': ['Drug: 68Ga-FAPI']}], 'interventions': [{'name': '68Ga-FAPI', 'type': 'DRUG', 'otherNames': ['68Ga-fibroblast activating protein inhibitors'], 'description': 'Intravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-FAPI. Tracer doses of 68Ga-FAPI will be used to image lesions of inflammatory bowel disease by PET/CT.', 'armGroupLabels': ['68Ga-FAPI, PET/CT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yaping Luo, MD', 'role': 'CONTACT', 'email': 'luoyaping@live.com', 'phone': '86-10-69155513'}, {'name': 'Qingqing Pan, MD', 'role': 'CONTACT', 'email': 'pqqelvay@126.com', 'phone': '86-10-69155513'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yaping Luo, MD', 'role': 'CONTACT', 'email': 'luoyaping@live.com', 'phone': '86-10-69155513'}, {'name': 'Qingqing Pan, MD', 'role': 'CONTACT', 'email': 'pqqelvay@126.com', 'phone': '86-10-69155513'}], 'overallOfficials': [{'name': 'Yaping Luo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}