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

Description

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.

Conditions

Idiopathic Pulmonary Fibrosis

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

Collagen-targeted PET Imaging for Assessment of EGCG Effect

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

Condition
Idiopathic Pulmonary Fibrosis
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Charlottesville

University of Virginia, Charlottesville, Virginia, United States, 22908

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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
  • 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.

Ages Eligible for Study

40 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hal Chapman,

Fernando Martinez, MD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

2026-03-25