Collagen-targeted Positron Emission Tomography (PET) Imaging for Assessment of EGCG Effect
NCT ID: NCT06265532
Last Updated: 2024-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
22 participants
INTERVENTIONAL
2024-02-07
2026-03-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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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.
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
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.
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
Patients enrolled in this group will be given oral capsule EGCG 600 mg daily with doctor provided anti-fibrotic for 12 weeks.
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
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.
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."
Interventions
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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."
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Signed informed consent
Exclusion Criteria
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.
40 Years
85 Years
ALL
No
Sponsors
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Cornell University
OTHER
Massachusetts General Hospital
OTHER
University of Michigan
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Hal Chapman
OTHER
Responsible Party
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Hal Chapman
Professor, Medicine
Principal Investigators
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Fernando Martinez, MD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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Pro00060157
Identifier Type: -
Identifier Source: org_study_id
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