Ignite Creation Date:
2024-05-06 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05339386
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2022-04-13
Brief Title:
Developing Hyperpolarized 129Xe MRI Biomarkers for Evaluation of Pulmonary Arterial Hypertension
Sponsor:
University of Kansas Medical Center
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
Developing Hyperpolarized 129Xe MRI Biomarkers for Evaluation of Pulmonary Arterial Hypertension
Status:
RECRUITING
Status Verified Date:
2024-05
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:
In this study hyperpolarized 129Xe MRI will be used to evaluate treatment efficacy in patients with pulmonary arterial hypertension PAH Participants will be imaged at 4 timepoints baseline 6 weeks post-therapy initiation 12 weeks and 18 weeks Images will be analyzed to develop new biomarkers and to understand treatment effects
Detailed Description:
1 Optimize Xe-MRI Oscillation Imaging for PAH Regional mapping of oscillations in the xenon RBC signal is a new technique that may provide new insights into microvascular function in PH Recent innovations in Xe-MRI have enabled improvements to this methodology but these have yet to be explored and optimized
2 Quantify the short- and long-term repeatability of Xe-MRI oscillation imaging in patients with PAH Hyperpolarized 129Xe oscillation imaging is a novel technique that may provide regional quantification of pulmonary microvascular function However the repeatability of this technique has not been measured which limits its use as an outcome measure
3 Determine the minimum time-point at which Xe-MRI shows a clinically meaningful change following treatment Current standards in the PAH community are to assess treatment efficacy in PAH patients at 3-6 months using 6MWTs REVEAL Lite scores echocardiograms and possibly RHCs However Xe-MRI may be more sensitive to functional improvements We hypothesize that Xe-MRI biomarkers will show a clinically meaningful change within 12 weeks of initiation of pulmonary vasodilators
2 Quantify the short- and long-term repeatability of Xe-MRI oscillation imaging in patients with PAH Hyperpolarized 129Xe oscillation imaging is a novel technique that may provide regional quantification of pulmonary microvascular function However the repeatability of this technique has not been measured which limits its use as an outcome measure
3 Determine the minimum time-point at which Xe-MRI shows a clinically meaningful change following treatment Current standards in the PAH community are to assess treatment efficacy in PAH patients at 3-6 months using 6MWTs REVEAL Lite scores echocardiograms and possibly RHCs However Xe-MRI may be more sensitive to functional improvements We hypothesize that Xe-MRI biomarkers will show a clinically meaningful change within 12 weeks of initiation of pulmonary vasodilators
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