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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06265532
Other study ID # Pro00060157
Secondary ID R33HL158540
Status Recruiting
Phase Phase 1
First received
Last updated
Start date February 7, 2024
Est. completion date May 31, 2025

Study information

Verified date February 2024
Source University of California, San Francisco
Contact Sydney Montesi, MD
Phone 617-724-4030
Email sbmontesi@mgb.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
EGCG 300 mg
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."
Placebo for EGCG 300 mg
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."
EGCG 600 mg
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."
Placebo for EGCG 600 mg
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."

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (5)

Lead Sponsor Collaborator
Hal Chapman Cornell University, Massachusetts General Hospital, National Heart, Lung, and Blood Institute (NHLBI), University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (2)

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):7 — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Change in peak enhancement over the entire lungs Changes in peak enhancement will be measured using dynamic-contrast enhanced MRI. This exploratory outcome is only relevant for participants that undergo PET/MRI. From baseline to 12 weeks
Other Change in the rate of contrast washin over the entire lungs Changes in rate of contrast washin will be measured using dynamic-contrast enhanced MRI. This exploratory outcome is only relevant for participants that undergo PET/MRI. From baseline to 12 weeks
Other Change in the area under the curve at 60 seconds over the entire lungs Changes in the area under the curve at 60 seconds will be measured using dynamic-contrast enhanced MRI. This exploratory outcome is only relevant for participants that undergo PET/MRI. From baseline to 12 weeks
Other Change in the full width at half maximum over the entire lungs Changes in the full width at half maximum will be measured using dynamic-contrast enhanced MRI. This exploratory outcome is only relevant for participants that undergo PET/MRI. From baseline to 12 weeks
Other Change in the rate of contrast washout over the entire lungs Changes in the rate of contrast washout will be measured using dynamic-contrast enhanced MRI. This exploratory outcome is only relevant for participants that undergo PET/MRI. From baseline to 12 weeks
Primary 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
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