ACTIVE_NOT_RECRUITING

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

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Conditions

Idiopathic Pulmonary Fibrosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Collagen-targeted PET Imaging for Assessment of EGCG Effect

Quick Facts

Study Start:2024-02-07
Study Completion:2026-03-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06265532

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.

Ages Eligible for Study:40 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Signed informed consent
  1. 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. 2. Research-related radiation exposure exceeds 50 millisievert (mSv) in the prior 12 months
  3. 3. Determined by the investigator to be clinically unsuitable for the study
  4. 1. Electrical implants such as cardiac pacemaker, defibrillator, or perfusion pump
  5. 2. Metallic or electric implants contraindicated for magnetic resonance-PET (MR-PET) scanning
  6. 3. Claustrophobic reactions
  7. 4. Estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73 m2 within the prior 30 days
  8. 5. Known allergy to gadolinium
  9. * 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.

Contacts and Locations

Principal Investigator

Fernando Martinez, MD
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
University of Virginia
Charlottesville, Virginia, 22908
United States

Collaborators and Investigators

Sponsor: Hal Chapman

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-07
Study Completion Date2026-03-25

Study Record Updates

Study Start Date2024-02-07
Study Completion Date2026-03-25

Terms related to this study

Additional Relevant MeSH Terms

  • Idiopathic Pulmonary Fibrosis