Collagen-targeted Positron Emission Tomography (PET) Imaging for Assessment of EGCG Effect
Completed · Phase 1 · Has a placebo group
Conditions studied: Idiopathic Pulmonary Fibrosis
In brief
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.
Key facts
- Study ID
- NCT06265532
- Run by
- Hal Chapman
- People needed
- 12
- Starts
- 2024-02-07
- Expected to finish
- 2026-01-08
- Last updated by the study team
- 2026-04-14
Who can join
Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Additional exclusion criteria for participants undergoing PET-MRI:
- 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
- Women of childbearing potential (WCBP) are defined as a sexually mature woman not surgically sterilized or not post-menopausal for at least 24 consecutive months if < 55 years or 12 months if ≥ 55 years.
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
- University of Michigan — Ann Arbor, Michigan, United States
- University of Virginia — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.