Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 12:34 AM
Study NCT ID:
NCT03482960
Status:
COMPLETED
Last Update Posted:
2021-01-25
First Post:
2018-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of 129Xe MRI With 19F MRI in CF Lung Disease
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
Comparison of 129Xe MRI With 19F MRI in CF Lung Disease
Status:
COMPLETED
Status Verified Date:
2020-09
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:
This study is designed to compare the capabilities of two novel imaging techniques: polarized perfluorinated gas mixed with oxygen, and hyperpolarized xenon mixed with N2 to detect changes in lung ventilation using MRI.
Detailed Description:
The goal of this study is to compare the capabilities of two novel imaging techniques: conventional 'thermally' polarized perfluorinated gases (perfluoropropane, or PFP) mixed with oxygen, and hyperpolarized xenon (129Xe) mixed with N2 to detect changes in lung ventilation using magnetic resonance imaging (MRI). Although considerable work has been done internationally with hyperpolarized xenon MRI, the low availability and high cost of this technique is limiting. Perfluorinated gas MRI is an alternative that may in fact be a suitable, simpler alternative. PFP is commercially availability in large quantities, which allows multiple breath studies and thus provides the ability to analyze gas wash-in and wash-out kinetics. These endpoints may improve the investigators ability to detect ventilation abnormalities beyond the traditional "ventilation defect percentage" parameter obtained with 129Xe MRI. The commercial availability of PFP and lack of need for onsite hyperpolarization may also facilitate the transfer of this technology to other centers for the conduct of multicenter studies. The investigators hypothesize that 19F MRI will not be inferior to hyperpolarized xenon MRI in detection of ventilation defect percentages (VDP).
Study Oversight
Has Oversight DMC:
False
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 |
|---|---|---|---|---|
| XePFP2017 | OTHER | University of North Carolina at Chapel Hill | View |