Imaging collagen to assess the effects of EGCG in lung disease

Collagen-targeted PET Imaging for Assessment of EGCG Effect

This study is testing if a special imaging technique can help see how well the drug EGCG works in people with Idiopathic Pulmonary Fibrosis by looking at changes in collagen in their lungs.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Ages: 40 Years to 85 Years
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Drugs / interventions: radiation
• Locations: 3 sites (Boston, Massachusetts and 2 other locations)
• Trial ID: NCT06265532 on ClinicalTrials.gov

What this trial studies

This study investigates the use of collagen-targeted PET imaging to evaluate the effects of the drug epigallocatechin-3-gallate (EGCG) on patients with Idiopathic Pulmonary Fibrosis (IPF). Participants enrolled in a larger phase I study will undergo PET imaging at two time points to measure collagen deposition changes. The goal is to determine if the imaging can help in assessing the drug's effectiveness and assist in selecting appropriate doses. The study will involve up to twenty-two participants and will be conducted at select medical centers equipped for this type of imaging.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with Idiopathic Pulmonary Fibrosis who are eligible for the main EGCG phase I study.

Not a fit: Patients who are pregnant, breastfeeding, or have certain medical implants may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective treatment strategies for patients with Idiopathic Pulmonary Fibrosis.

How similar studies have performed: While the use of PET imaging in this context is innovative, similar studies have shown promise in assessing treatment effects in other conditions.

Eligibility criteria

Inclusion Criteria:

1. 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
2. Signed informed consent

Exclusion Criteria:

1. 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)\*
2. Research-related radiation exposure exceeds 50 millisievert (mSv) in the prior 12 months
3. Determined by the investigator to be clinically unsuitable for the study

Additional exclusion criteria for participants undergoing PET-MRI:

1. Electrical implants such as cardiac pacemaker, defibrillator, or perfusion pump
2. Metallic or electric implants contraindicated for magnetic resonance-PET (MR-PET) scanning
3. Claustrophobic reactions
4. Estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73 m2 within the prior 30 days
5. 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 this trial is running

Boston, Massachusetts and 2 other locations

• Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
• University of Michigan — Ann Arbor, Michigan, United States (Not_yet_recruiting)
• University of Virginia — Charlottesville, Virginia, United States (Not_yet_recruiting)

Study contacts

• Principal investigator: Fernando Martinez, MD — Weill Medical College of Cornell University
• Study coordinator: Sydney Montesi, MD

Conditions Idiopathic Pulmonary Fibrosis