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.
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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