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

NCT06265532 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: Pro00060157R33HL158540
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Change in collagen probe uptake over the entire lungs

  Changes in lung collagen uptake will be measured using the PET probe \[68\]Ga-CBP8. Measurements will be made over the entire lungs using standardized uptake values.

  From baseline to 12 weeks

Other Outcomes (5)

• Change in peak enhancement over the entire lungs

  From baseline to 12 weeks

• Change in the rate of contrast washin over the entire lungs

  From baseline to 12 weeks

• Change in the area under the curve at 60 seconds over the entire lungs

  From baseline to 12 weeks

Study Arms (4)

EGCG 300 mg

ACTIVE COMPARATOR

Patients enrolled in this group will be given oral capsule EGCG 300 mg daily with doctor provided anti-fibrotic for 12 weeks.

Drug: EGCG 300 mg

Placebo for EGCG 300 mg

PLACEBO COMPARATOR

Patients enrolled in this group will be given oral capsule Placebo daily for 12 weeks with doctor provided anti-fibrotic. The number of placebo capsules will be equal to that of 300 mg EGCG.

Drug: Placebo for EGCG 300 mg

EGCG 600 mg

ACTIVE COMPARATOR

Patients enrolled in this group will be given oral capsule EGCG 600 mg daily with doctor provided anti-fibrotic for 12 weeks.

Drug: EGCG 600 mg

Placebo for EGCG 600 mg

PLACEBO COMPARATOR

Patients enrolled in this group will be given oral capsule Placebo daily for 12 weeks with doctor provided anti-fibrotic. The number of placebo capsules will be equal to that of 600 mg EGCG.

Drug: Placebo for EGCG 600 mg

Interventions

EGCG 300 mg DRUG

Participants will be administered EGCG as part of the phase I 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."

Also known as: Dietary Supplement: EGCG Capsules with EGCG (at least 94% purity). 300 mg EGCG (2 capsules) taken orally daily for 12 weeks.

EGCG 300 mg

EGCG 600 mg DRUG

Participants will be administered placebo for EGCG as part of the phase I 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."

Also known as: Dietary Supplement: EGCG Capsules with EGCG (at least 94% purity). 600 mg EGCG (4 capsules) taken orally daily for 12 weeks.

EGCG 600 mg

Placebo for EGCG 300 mg DRUG

Participants will be administered placebo for EGCG as part of the phase I 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."

Also known as: Dietary Supplement: Placebo Placebo (2 capsules) taken orally daily for 12 weeks.

Placebo for EGCG 300 mg

Placebo for EGCG 600 mg DRUG

Participants will be administered placebo for EGCG as part of the phase I 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."

Also known as: Dietary Supplement: Placebo Placebo (4 capsules) taken orally daily for 12 weeks.

Placebo for EGCG 600 mg

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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.

Sponsors & Collaborators

• Hal Chapman: lead
• Cornell University: collaborator
• Massachusetts General Hospital: collaborator
• University of Michigan: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (2)

• Montesi SB, Izquierdo-Garcia D, Desogere P, Abston E, Liang LL, Digumarthy S, Seethamraju R, Lanuti M, Caravan P, Catana C. Type I Collagen-targeted Positron Emission Tomography Imaging in Idiopathic Pulmonary Fibrosis: First-in-Human Studies. Am J Respir Crit Care Med. 2019 Jul 15;200(2):258-261. doi: 10.1164/rccm.201903-0503LE. No abstract available.

  PMID: 31161770 BACKGROUND

• Izquierdo-Garcia D, Desogere P, Fur ML, Shuvaev S, Zhou IY, Ramsay I, Lanuti M, Catalano OA, Catana C, Caravan P, Montesi SB. Biodistribution, Dosimetry, and Pharmacokinetics of 68Ga-CBP8: A Type I Collagen-Targeted PET Probe. J Nucl Med. 2023 May;64(5):775-781. doi: 10.2967/jnumed.122.264530. Epub 2022 Dec 8.

  PMID: 37116909 RESULT

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

epigallocatechin gallate

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Fernando Martinez, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participants will be on one of the standard of care drugs (nintedanib or pirfenidone) and blindly given EGCG or placebo.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Medicine

Model Details: This is an optional substudy to the phase I 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." Up to twenty-two participants participating in the aforementioned study will be enrolled into this sub-study. This substudy will be conducted at a select number of sites with capabilities for performing \[68Ga\]CBP8 PET.

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 20, 2024
• Study Start: February 7, 2024
• Primary Completion: January 8, 2026
• Study Completion: January 8, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)