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

Phase 1

Recruiting

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: EGCG 300 mg; Drug: Placebo for EGCG 300 mg; Drug: EGCG 600 mg; Drug: Placebo for EGCG 600 mg

• Registration Number: NCT06265532
• Lead Sponsor: Hal Chapman

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.

Detailed Description

This is an optional sub-study 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, pharmacokinetic (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.

Eligible participants who consent to the substudy will undergo \[68Ga\]CBP8 PET-CT or \[68Ga\]CBP8 PET-MRI at two time points. Participants will undergo 68Ga-CBP8 PET within 7 days prior to randomization and then again within 7 days prior to day 84 of the phase I study.

The hypothesis is that \[68Ga\]CBP8 PET will detect decreased collagen deposition in individuals treated with EGCG compared to placebo.

Study Timeline

• Study Start: 2024-02-07
• Study First Submitted: 2024-02-09
• Study First Submitted QC: 2024-02-09
• Study First Posted: 2024-02-20
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18
• Primary Completion: 2026-03-25
• Study Completion: 2026-03-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
EGCG 300 mg	EGCG 300 mg	Patients enrolled in this group will be given oral capsule EGCG 300 mg daily with doctor provided anti-fibrotic for 12 weeks.
Placebo for EGCG 300 mg	Placebo for EGCG 300 mg	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.
EGCG 600 mg	EGCG 600 mg	Patients enrolled in this group will be given oral capsule EGCG 600 mg daily with doctor provided anti-fibrotic for 12 weeks.
Placebo for EGCG 600 mg	Placebo for EGCG 600 mg	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.

Primary Outcome Measures

Name	Time	Method
Change in collagen probe uptake over the entire lungs	From baseline to 12 weeks	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.

Trial Locations

Locations (3)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States