Idiopathic Pulmonary Fibrosis Clinical Trial
Official title:
Collagen-targeted PET Imaging for Assessment of EGCG Effect
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.
Status | Recruiting |
Enrollment | 22 |
Est. completion date | May 31, 2025 |
Est. primary completion date | May 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 85 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Hal Chapman | Cornell University, Massachusetts General Hospital, National Heart, Lung, and Blood Institute (NHLBI), University of Michigan |
United States,
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
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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