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| ID | Type | Description | Link |
|---|---|---|---|
| R33HL158540 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Cornell University | OTHER |
| Massachusetts General Hospital | OTHER |
| University of Michigan | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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." |
| Measure | Description | Time Frame |
|---|---|---|
| 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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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in the rate of contrast washin over the entire lungs |
Inclusion Criteria:
Exclusion Criteria:
Additional exclusion criteria for participants undergoing PET-MRI:
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
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Martinez, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| University of Michigan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31161770 | Background | 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. | |
| 37116909 | Result | 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. |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C045651 | epigallocatechin gallate |
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| NIH |
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.
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All participants will be on one of the standard of care drugs (nintedanib or pirfenidone) and blindly given EGCG or placebo.
|
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| 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." |
|
|
| 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." |
|
|
| 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." |
|
|
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 |
| 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 |
| 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 |
| 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 |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |