Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT05365802
Status:
RECRUITING
Last Update Posted:
2025-07-03
First Post:
2022-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FAPI PET for Lung Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D054988', 'term': 'Idiopathic Interstitial Pneumonias'}, {'id': 'D000542', 'term': 'Alveolitis, Extrinsic Allergic'}, {'id': 'D017564', 'term': 'Radiation Pneumonitis'}, {'id': 'D011009', 'term': 'Pneumoconiosis'}, {'id': 'D011658', 'term': 'Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000706531', 'term': 'FAPI-46'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Group Assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2022-04-22', 'studyFirstSubmitQcDate': '2022-05-03', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To define and document the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) in patients with Interstitial Lung Disease', 'timeFrame': '60 minutes following injection', 'description': 'To quantify diseased tissue and normal background organs, 68Ga-FAPI-46 positron emission tomography (PET) tracer biodistribution will be assessed by semi-quantitative analysis (unit/metrics = standardized uptake values (SUV)).'}], 'secondaryOutcomes': [{'measure': '68Ga-FAPi-46 accumulation', 'timeFrame': 'Up to 2 years', 'description': 'To evaluate the degree of 68Ga-FAPi-46 accumulation observed by PET imaging as opposed to the amount of FAP expression in obtained lung tissue, when available. IHC will be scored with a semi-quantitative scoring system that accounts for staining intensity (0-2, where 0 is negative, 1 is weak, 2 is strong and eq. stands for equivocal). Correlations will be sought using least square regression analysis.'}, {'measure': '68Ga-FAPi-46 and disease progression', 'timeFrame': 'Up to 2 years', 'description': 'To evaluate whether the 68Ga-FAPi-46 biodistribution in the lungs can be associated with disease progression under ILD therapies.'}, {'measure': '68Ga-FAPi-46 biodistribution', 'timeFrame': 'Up to 2 years', 'description': 'To evaluate whether the 68Ga-FAPi-46 biodistribution in the lungs can be associated with HR CT quantitative parameters'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['interstitial lung disease', 'pulmonary fibrosis', '68Ga-FAPi-46'], 'conditions': ['Interstitial Lung Disease', 'Idiopathic Interstitial Pneumonias', 'Drug-Induced Pneumonitis', 'Hypersensitivity Pneumonitis', 'Radiation Pneumonitis', 'Pneumoconiosis', 'Pulmonary Fibrosis']}, 'descriptionModule': {'briefSummary': 'This is a prospective exploratory biodistribution study in patients with interstitial lung disease (ILD).\n\nThe purpose of this research study is to determine where and to which degree the FAPI tracer (68Ga-FAPI-46) accumulates in normal and fibrotic lung tissues of patients with interstitial lung disease.\n\nThe study will include patients with interstitial lung disease who have or will initiate a new ILD medication OR will undergo tissue biopsy or surgery of the lung.\n\nThe study will include 30 patients, the upper limit for PET imaging studies conducted under the Radioactive Drug Research Committee (RDRC) purview.\n\nParticipants will be injected with up to 7 mCi of 68-GaFAPi and will undergo one PET/CT scan and one High Resolution CT of the lungs.\n\nThe study is sponsored by Ahmanson Translational Theranostic Division at UCLA.', 'detailedDescription': 'ILD is a group of respiratory diseases that affect the interstitium of the lungs. A major problem is the highly variable course of fibrosing ILD: some patients remain stable without treatment, and others progress rapidly despite pharmacotherapy.\n\nNovel diagnostic approaches for risk stratification with more accurate prediction of the course of fibrosing ILD could potentially improve prognostication and ultimately lead to better survival in these patients.\n\nPersistent activation and local accumulation of myofibroblasts is a common feature of fibrotic diseases. FAP is a promising target for molecular imaging of fibroblast activation and detection of sites of active tissue remodeling.\n\nSmall molecule inhibitors of FAP have been labeled with positron-emitting isotopes for PET imaging. 68Ga-FAPi-46 can serve as diagnostic biomarker in ILD.\n\nIn this study, the investigators will evaluate the 68Ga-FAPi-46 biodistribution in patients with ILD and observe the correlation of FAP expression and FAPi radiopharmaceutical uptake.\n\nThe primary objective of this study is to evaluate the biodistribution of the new FAP-targeted PET tracer, 68Ga-FAPi- 46, in patients with ILD.\n\nOUTLINE:\n\n1. Participants with Interstitial Lung Disease will be asked to undergo a 68Ga-FAPi-46 PET/CT and one High Resolution CT of the lungs\n2. Patients will be followed until pathology is obtained during clinical care. (if undergoing surgery or biopsy)\n3. Biodistribution results will be assessed comparing pathological findings and PET/CT results'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Patients with ILD confirmed by CT at time of staging\n* Patients who have initiated or will initiate a new ILD medication with 3 months of enrollment OR Patients who are scheduled to undergo tissue biopsy or surgery of the lung\n* Patients are ≥ 18 years old at the time of the radiotracer administration\n* Patient can provide written informed consent\n\nExclusion criteria\n\n* Patient is pregnant or nursing\n* Patients with active infectious lung disease\n* Patients not expected to comply with the protocol requirements, not able to understand or follow trial procedures'}, 'identificationModule': {'nctId': 'NCT05365802', 'acronym': 'FAPI ILD', 'briefTitle': 'FAPI PET for Lung Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'PET Study of 68Ga-FAPi-46 in Patients With Interstitial Lung Disease: an Exploratory Biodistribution Study With Histopathology Validation.', 'orgStudyIdInfo': {'id': 'IRB21-000678'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '68Ga-FAPi-46', 'description': 'Patients receive 68Ga-FAPi-46 IV and undergo PET/CT scan over 20-50 minutes', 'interventionNames': ['Drug: 68Ga-FAPi-46', 'Procedure: Computed Tomography', 'Procedure: Positron Emission Tomography', 'Procedure: High Resolution Computed Tomography']}], 'interventions': [{'name': '68Ga-FAPi-46', 'type': 'DRUG', 'otherNames': ['Gallium-68-FAPi-46'], 'description': 'Radiopharmaceutical will be administered via IV', 'armGroupLabels': ['68Ga-FAPi-46']}, {'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['CT scan'], 'description': 'As part of PET/CT scan', 'armGroupLabels': ['68Ga-FAPi-46']}, {'name': 'Positron Emission Tomography', 'type': 'PROCEDURE', 'otherNames': ['PET scan'], 'description': 'As part of PET/CT scan', 'armGroupLabels': ['68Ga-FAPi-46']}, {'name': 'High Resolution Computed Tomography', 'type': 'PROCEDURE', 'description': 'Will be conducted immediately after FAPI PET/CT', 'armGroupLabels': ['68Ga-FAPi-46']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UCLA / Jonsson Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Stephanie Lira', 'role': 'CONTACT', 'email': 'StephanieLira@mednet.ucla.edu', 'phone': '3102067372'}, {'name': 'Contreras M Maria, BS', 'role': 'CONTACT', 'email': 'MMContreras@mednet.ucla.edu', 'phone': '3102067372'}], 'overallOfficials': [{'name': 'Jeremie Calais, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research Director, Ahmanson Translational Theranostics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Research Director, Ahmanson Translational Theranostics', 'investigatorFullName': 'Jeremie Calais', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}