Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT06265532
Status:
RECRUITING
Last Update Posted:
2024-11-18
First Post:
2024-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Collagen-targeted Positron Emission Tomography (PET) Imaging for Assessment of EGCG Effect
Sponsor:
Hal Chapman
Organization:
Study Overview
Official Title:
Collagen-targeted PET Imaging for Assessment of EGCG Effect
Status:
RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R33HL158540 | NIH | None | https://reporter.nih.gov/quic… | View |