Ignite Creation Date:
2024-05-06 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03492762
Status:
RECRUITING
Last Update Posted:
2022-10-05
First Post:
2018-03-26
Brief Title:
PET Imaging CCR2 in Lung Inflammation
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
PET Imaging CCR2 in Lung Inflammation
Status:
RECRUITING
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to assess the lung distribution of the Positron Emission Tomography PET imaging radiotracer Cu-DOTA-ECL1i which binds to the specific population inflammatory cells in patients with fibrotic lung diseases This objective includes sub-studies to assess radiotracer distribution in the lung the reproducibility of PET scans and the relationship of the scan to distribution of inflammatory cells in human lung tissue The overall goal is to assess the potential of the radiotracer to track inflammatory cells in lung diseases
Detailed Description:
This is a single site pilot Phase 01 clinical trial to establish the uptake of Cu-DOTA-ECL1i in additional patients with ILD fibrotic lung disease n60 Healthy volunteers without known pulmonary disease will be recruited as controls N5 All subjects will be recruited and undergo one dynamic PETCT scan to characterize the lung uptake of Cu-DOTA-ECL1i Among those with pulmonary fibrosis imaging an arterial catheter will be placed for blood draws in n10 subjects an additional sub group of subjects n10 will undergo a second PETCT within two months A third subgroup of subjects n10 who undergo lung transplant will have analysis of CCR2 cells in their explanted lungs
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 |
|---|---|---|---|
| R01HL151685-01A1 | NIH | None | httpsreporternihgovquickSearchR01HL151685-01A1 |