protocolSection identificationModule nctId: NCT06265532, orgStudyIdInfo id: Pro00060157, secondaryIdInfos id: R33HL158540, type: NIH, link: https://reporter.nih.gov/quickSearch/R33HL158540, briefTitle: Collagen-targeted Positron Emission Tomography (PET) Imaging for Assessment of EGCG Effect, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Hal Chapman, class: OTHER, collaborators name: Cornell University, collaborators name: Massachusetts General Hospital, collaborators name: University of Michigan, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: The primary purpose of this substudy is to determine if collagen-targeted PET using the type 1 collagen-targeted PET probe, Gallium-68 (68Ga)-labeled collagen binding probe 8 (CBP8) can inform as to drug effect of EGCG and assist in dose selection., conditionsModule conditions: Idiopathic Pulmonary Fibrosis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: This is an optional substudy to the phase I study: "Dose ranging study of oral epigallocatechin-3-gallate (EGCG) given daily for 12 weeks to patients with Idiopathic Pulmonary Fibrosis (IPF) evaluating safety, PK interactions with standard of care drugs, and biomarkers of drug effect." Up to twenty-two participants participating in the aforementioned study will be enrolled into this sub-study. This substudy will be conducted at a select number of sites with capabilities for performing \[68Ga\]CBP8 PET., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: All participants will be on one of the standard of care drugs (nintedanib or pirfenidone) and blindly given EGCG or placebo., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: EGCG 300 mg, interventions name: Placebo for EGCG 300 mg, interventions name: EGCG 600 mg, interventions name: Placebo for EGCG 600 mg, outcomesModule primaryOutcomes measure: Change in collagen probe uptake over the entire lungs, otherOutcomes measure: Change in peak enhancement over the entire lungs, otherOutcomes measure: Change in the rate of contrast washin over the entire lungs, otherOutcomes measure: Change in the area under the curve at 60 seconds over the entire lungs, otherOutcomes measure: Change in the full width at half maximum over the entire lungs, otherOutcomes measure: Change in the rate of contrast washout over the entire lungs, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Massachusetts General Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: Sydney Montesi, MD, role: CONTACT, phone: 617-724-4030, email: SBMONTESI@PARTNERS.ORG, contacts name: Caroline Fromson, role: CONTACT, phone: 617-643-3260, email: CFROMSON@MGH.HARVARD.EDU, contacts name: Sydney Montesi, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False