Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-27 @ 7:48 AM
Study NCT ID:
NCT06604260
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FAPi-PET Imaging of in Vivo Fibrosis in Inflammatory Bowel Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-17', 'studyFirstSubmitDate': '2024-09-17', 'studyFirstSubmitQcDate': '2024-09-17', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Correspondence 68Ga-FAPi bowel uptake conventional imaging modalities and cellular FAP', 'timeFrame': 'At baseline up to week 12 of study enrolment', 'description': 'To determine to what extent 68Ga-FAPi bowel uptake in IBD patients corresponds to conventional imaging modalities and FAP protein and transcriptome expression levels.'}], 'primaryOutcomes': [{'measure': "Detection of areas with increased 68Ga-FAPi uptake in Crohn's disease patients", 'timeFrame': 'At baseline up to week 12 of study enrolment', 'description': "Detection of areas with increased 68Ga-FAPi uptake (both visually as semi-quantitatively) in the terminal ileum and colon on baseline PET/CT of active Crohn's disease patients compared to bowel uptake reference values as derived in other Amsterdam UMC 68Ga-FAPi PET imaging studies in patients not suffering from IBD (when signed informed consent is available)."}, {'measure': 'Detection of areas with increased 68Ga-FAPi uptake in ulcerative colitis patients', 'timeFrame': 'At baseline up to week 12 of study enrolment', 'description': 'Detection of areas with increased 68Ga-FAPi uptake (both visually as semi-quantitatively) in the terminal ileum and colon on baseline PET/CT of ulcerative colitis patients compared to bowel uptake reference values as derived in other Amsterdam UMC 68Ga-FAPi PET imaging studies in patients not suffering from IBD (when signed informed consent is available).'}], 'secondaryOutcomes': [{'measure': 'Visual and semi-quantitative evaluation of the pharmacokinetics (PK) of 68Ga-FAPi', 'timeFrame': 'At baseline up to week 12 of study enrolment', 'description': "Visual and semi-quantitative evaluation of the pharmacokinetics (PK) of 68Ga-FAPi in patients with a) Crohn's disease and b) ulcerative colitis compared to bowel uptake reference values as derived in other Amsterdam UMC 68Ga-FAPi imaging studies in patients not suffering from IBD (when signed informed consent is available)."}, {'measure': 'Protocol optimisation', 'timeFrame': 'At baseline up to week 12 of study enrolment', 'description': "To define optimal (single and/or dual) time point(s) post injection for imaging FAP activity in Crohn's disease and ulcerative colitis."}, {'measure': 'Minimal tracer injection dose', 'timeFrame': 'At baseline up to week 12 of study enrolment', 'description': 'Determine the minimal tracer injection dose required to have comparable disease detection performance on PET as to the full tracer injection dose PET.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FAPI', 'fibroblast activation protein', 'FAP', 'FAPi-scan', '68Ga-FAPi PET-CT'], 'conditions': ['IBD (Inflammatory Bowel Disease)', 'Crohn Disease (CD)', 'Ulcerative Colitis (UC)']}, 'descriptionModule': {'briefSummary': 'Our main objective is to evaluate the feasibility of 68Ga-FAPi PET/CT in detecting intestinal fibrosis in patients with IBD. To this end, we will determine 68Ga-FAPi uptake in IBD in relation to cellular FAP expression in intestinal biopsies and resection specimens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nGroup 1\n\n\\- Adults ≥18 years with confirmed diagnosis of Crohn's disease\n\nAND one of the following:\n\n* Gastrointestinal complaints such as diarrhea, bloody and/ or lose stools and abdominal pain, or obstructive symptoms.\n* Increased CRP (\\>5 mg/L) and/or fecal calprotectin levels (\\>250 mg/kg)\n* Active disease confiremed by endoscopy ( endoscopic SES-CD score \\>3)\n* Active disease confirmed by IUS or MRI (bowel wall thickening, signs of active disease) Group 2\n* Adults ≥18 years with confirmed diagnosis of ulcerative colitis\n\nAND one of the following:\n\n* Active disease confirmed by endoscopy (endoscopic Mayo score ≥ 2) or\n* Active disease confirmed by intestinal ultrasound (BWT \\> 3 mm in atleast one bowel segment and atleast one other pathological IUS parameter)\n* Increased CRP (\\>5 mg/L) and/or fecal calprotectin levels (\\>250 mg/kg)\n\nExclusion Criteria:\n\n* Pregnancy\n* Unable to provide informed consent\n* IBD-related surgeries \\< 5 years in medical history\n* Colorectal carcinoma"}, 'identificationModule': {'nctId': 'NCT06604260', 'acronym': 'PIMAFI', 'briefTitle': 'FAPi-PET Imaging of in Vivo Fibrosis in Inflammatory Bowel Disease Patients', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'FAPi-PET Imaging of in Vivo Fibrosis in Inflammatory Bowel Disease Patients', 'orgStudyIdInfo': {'id': 'NL82160.029.22'}, 'secondaryIdInfos': [{'id': '2022-002751-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IBD patients', 'description': "Ulcerative colitis and Crohn's disease patients", 'interventionNames': ['Diagnostic Test: 68Ga-FAPi-46']}], 'interventions': [{'name': '68Ga-FAPi-46', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['FAPi-scan'], 'description': '68Ga FAPi PET-CT scan', 'armGroupLabels': ['IBD patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1081 BT', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Amsterdam UMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'Dalia A Lartey, MD', 'role': 'CONTACT', 'email': 'd.a.lartey@amsterdamumc.nl', 'phone': '+31205668160'}], 'overallOfficials': [{'name': 'Mark Lowenberg, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amsterdam UMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dalia Lartey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Drs', 'investigatorFullName': 'Dalia Lartey', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}