Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT06189820
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of the Fibroblast Activation Protein (FAP) as Biomarker of Fibrotic Lung Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2027-03-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-18', 'studyFirstSubmitDate': '2023-11-22', 'studyFirstSubmitQcDate': '2023-12-18', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FAPI uptake on PET/CT', 'timeFrame': 'From date of inclusion till date of the second FAPI PET/CT (after 3 months)', 'description': 'Decrease in lung FAPI uptake after the initiation of treatment, measured with the following PET parameters: SUVmax, SUVmean and Total lesion fapi uptake (TLA) in the lungs of the patients'}], 'secondaryOutcomes': [{'measure': 'Correlation between lung FAP expression and clinical evolution', 'timeFrame': 'From date of inclusion for a period of 2 years', 'description': 'Correlation between lung FAP expression (as assessed on blood/BAL or on FAPI PET/CT) and the clinical evolution based on the analysis of the slope of FVC decreased, absolute and relative changes in FVC at 12 months, time to progression/death or lung transplantation, time to first acute exacerbation'}, {'measure': 'Comparison of different FAPi tracers', 'timeFrame': 'From date of inclusion till the second FAPi PET/CT (maximum period of 4 weeks)', 'description': 'Comparison of PET parameters on 68Ga-FAPI and 18F-FAPI images (SUVmax, SUVmean) in lungs'}, {'measure': 'Comparison of different FAPi tracers', 'timeFrame': 'From date of inclusion till the second FAPi PET/CT (maximum period of 4 weeks)', 'description': 'Comparison of PET parameters of 68Ga-FAPI and 18F-FAPI images (SUVmax, SUVmean) in blood pool'}, {'measure': 'Correlation between lung FAPI uptake and corresponding FAP assessment in blood and BAL samples.', 'timeFrame': 'From date of inclusion till last BAL sample taken, up to a maximum period of 2 years follow-up', 'description': 'Correlation between lung FAPI uptake on the PET images (SUVmean, SUVmax, TLA) and corresponding quantitative FAP assessment in blood and BAL samples.'}, {'measure': 'Correlation between lung FAPI uptake and immunohistological evaluation of the FAP expression on lung samples (after lung transplantation, surgical lung biopsy or cryobiopsy)', 'timeFrame': 'From date of inclusion until surgery, for a maximum period of 2 years', 'description': 'Correlation between lung FAPI uptake on the PET images (SUVmean, SUVmax, TLA) and immunohistological evaluation of the FAP expression on lung samples (after lung transplantation, surgical lung biopsy or cryobiopsy)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary fibrosis', 'FAP'], 'conditions': ['Pulmonary Fibrosis', 'Lung Fibrosis', 'Idiopathic Pulmonary Fibrosis', 'FAP']}, 'descriptionModule': {'briefSummary': 'To evaluate the effect of an anti-fibrotic treatment initiation on the fibrotic activity as assessed by FAPI PET/CT.', 'detailedDescription': 'To evaluate the use of the fibroblast activation protein (FAP) as a biomarker of fibrotic lung disease (idiopathic pulmonary fibrosis (IPF) and non-IPF ILDs). The study will include both analysis of FAP expression in samples stored in the biobank of the department of Pneumology (BAL, blood, induced sputum and EBC) (cohort A) and lung FAPI uptake on PET/CT scans performed at the department of Nuclear Medicine:\n\n* before and after the initiation of an antifibrotic therapy (IPF or PPF) (cohort B)\n* before and after the initiation of corticosteroid therapy in case of an acute exacerbation of ILD (cohort C)\n* before and after the initiation of an immunosuppressive drug in the context of non-IPF pulmonary fibrosis (cohort D).\n* before lung transplantation, surgery or biopsy to correlate with FAP expression determined by immunohistochemical analysis (IHC) (cohort E).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults patients with a fibrotic lung disease (idiopathic pulmonary fibrosis (IPF) or non-IPF fibrotic ILD) as defined according to the 2022 ATS/ERS/JRS/ALAT Clinical Practice Guidelines\n\nExclusion Criteria:\n\n* Pregnant or nursing patients\n* Patients with another significant medical condition which, in the investigator's opinion, may interfere with the completion of the study.\n* Patients with an active lung neoplasm or any active neoplasm for blood samples"}, 'identificationModule': {'nctId': 'NCT06189820', 'acronym': 'FAPIPET', 'briefTitle': 'Role of the Fibroblast Activation Protein (FAP) as Biomarker of Fibrotic Lung Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Erasme University Hospital'}, 'officialTitle': 'Role of the Fibroblast Activation Protein (FAP) as Biomarker of Fibrotic Lung Diseases', 'orgStudyIdInfo': {'id': 'P2022/587'}}, 'armsInterventionsModule': {'interventions': [{'name': 'FAPI PET/CT', 'type': 'DIAGNOSTIC_TEST', 'description': 'In the department of Nuclear Medicine:\n\n* Installation in a relax chair after weight and height control\n* Placement of a venous line in the upper limb after which an infusion of 500ml of 0.9% NaCl is started.\n* Intravenous injection of 3 MBq/kg (max 300 MBq) of 18F- FAPI 74 or of 2 MBq/kg 68Ga-FAPI46'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Benjamin Bondue', 'role': 'CONTACT', 'email': 'benjamin.bondue@hubruxelles.be', 'phone': '+ 32 (2) 555 5758'}], 'facility': 'Medecine', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Benjamin Bondue', 'role': 'CONTACT', 'email': 'benjamin.bondue@hubruxelles.be', 'phone': '+ 32 (2) 555 5758'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasme University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}