CompletedPhase 1

Collagen-targeted Positron Emission Tomography (PET) Imaging for Assessment of EGCG Effect

United States12 participantsStarted 2024-02-07

Plain-language summary

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.

Who can participate

Age range40 Years – 85 Years

SexALL

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Inclusion criteria

✓. Enrolled in and eligible (based on screening procedures - Visit 1) for the main EGCG Phase 1 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
✓. Signed informed consent

Exclusion criteria

✕. Pregnant or breastfeeding (a negative quantitative serum human chorionic gonadotropin (hCG) pregnancy test is required for females having child-bearing potential before the participant can participate)\*
✕. Research-related radiation exposure exceeds 50 millisievert (mSv) in the prior 12 months
✕. Determined by the investigator to be clinically unsuitable for the study
✕. Electrical implants such as cardiac pacemaker, defibrillator, or perfusion pump
✕. Metallic or electric implants contraindicated for magnetic resonance-PET (MR-PET) scanning
✕. Claustrophobic reactions
✕. Estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73 m2 within the prior 30 days
✕. Known allergy to gadolinium

What they're measuring

Change in collagen probe uptake over the entire lungs

Timeframe: From baseline to 12 weeks

Trial details

NCT IDNCT06265532

SponsorHal Chapman

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-08

View on ClinicalTrials.gov More Idiopathic Pulmonary Fibrosis trials