Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06265532
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-02-09
Brief Title:
Collagen-targeted Positron Emission Tomography PET Imaging for Assessment of EGCG Effect
Sponsor:
Hal Chapman
Organization:
University of California San Francisco
Study Overview
Official Title:
Collagen-targeted PET Imaging for Assessment of EGCG Effect
Status:
RECRUITING
Status Verified Date:
2024-02
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 68GaCBP8 PET
Eligible participants who consent to the substudy will undergo 68GaCBP8 PET-CT or 68GaCBP8 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 68GaCBP8 PET will detect decreased collagen deposition in individuals treated with EGCG compared to placebo
Eligible participants who consent to the substudy will undergo 68GaCBP8 PET-CT or 68GaCBP8 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 68GaCBP8 PET will detect decreased collagen deposition in individuals treated with EGCG compared to placebo
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R33HL158540 | NIH | None | httpsreporternihgovquickSearchR33HL158540 |