NCT06265532CompletedPhase 1
Collagen-targeted Positron Emission Tomography (PET) Imaging for Assessment of EGCG Effect
Collagen-targeted PET Imaging for Assessment of EGCG Effect
Source: ClinicalTrials.gov · Last updated 14 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 9 Feb 2024
- Start date
- 7 Feb 2024
- Primary completion date
- 8 Jan 2026
- Lead sponsor
- Hal Chapman
- Diseases
- Idiopathic pulmonary fibrosis
- NCT number
- NCT06265532
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 12
- From 7 Feb 2024 to the primary completion date, 8 Jan 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Research-related radiation exposure exceeds 50 millisievert (mSv) in the prior 12 months
- Metallic or electric implants contraindicated for magnetic resonance-PET (MR-PET) scanning
Other illness
- Electrical implants such as cardiac pacemaker, defibrillator, or perfusion pump
Lab values
- 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)\*
- Estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73 m2 within the prior 30 days
Age
- 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.
Other
- Determined by the investigator to be clinically unsuitable for the study
- Additional exclusion criteria for participants undergoing PET-MRI:
- Claustrophobic reactions
Who the study is looking for
- 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
Age in the registry: 40 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.