Ignite Creation Date:
2024-05-06 @ 3:24 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04624490
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2020-10-31
Brief Title:
Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease
Sponsor:
Mario Castro MD MPH
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease
Status:
RECRUITING
Status Verified Date:
2024-06
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 purpose of this study is to develop and evaluate the usefulness of hyperpolarized HP 129Xe gas MRI for regional assessment of pulmonary function
Detailed Description:
This is an unblinded open-label study with 160 subjects with diagnosed pulmonary disease and 100 healthy controls Subjects to be enrolled will include males and females 18-80 years old Evaluation will be on an outpatient basis Imaging will be done on a single day and will involve administration of up to four 1-liter doses of HP 129Xe plus one 129Xe calibration dose 300-400mL HP 129Xe In addition to 129Xe MRI a series of anatomical conventional 1H MR images will be collected including a localizer scan breath-hold spin echo image and breath-hold steady-state free precession image to highlight the vasculature All subjects will be evaluated at one center The University of Kansas Medical Center KS USA
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