Ignite Creation Date:
2024-05-06 @ 4:27 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04991454
Status:
RECRUITING
Last Update Posted:
2023-11-13
First Post:
2021-07-07
Brief Title:
Xenon MRI Pulm Hypertension
Sponsor:
Bastiaan Driehuys
Organization:
Duke University
Study Overview
Official Title:
Xenon MRI in Pulmonary Hypertension
Status:
RECRUITING
Status Verified Date:
2023-11
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:
Jupiter PH
Brief Summary:
The overall objective outlined in this study is to determine how pulmonary vascular remodeling in PAH at a cellular and pathological level is associated with changes in gas exchange physiology and hemodynamics monitored with 129Xe MRIMRS and how these signals change with disease progression or treatment
Detailed Description:
In aim 1 the study team will compare 129Xe MRI signatures to lung explant pathology cellular identity from single-cell RNA sequencing and cellular phenotypes in gas exchange defects to areas that are spared which the team will hypothesize are exposed to lower levels of hemodynamic shear stress This will be done by performing 129Xe MRI scans in fifteen subjects cohort 1 with PAH awaiting a lung transplant followed by a pathologic assessment with usual histopathology and single cell RNA sequencing of the subjects explanted lung after transplant The study team expect that areas of proliferation and fibrosis will correlate with 129Xe MRI gas exchange and spectroscopic defects
In aim 3 The study team will test whether directly monitoring lung pathology with 129Xe MRI will provide additional prognostic information to standard-of-care clinical monitoring in 45 subjects cohort 2 At 6-month follow-up appointments standard-of-care assessments including labs echocardiography and six-minute walk distance and 129Xe MRI will be collected The study team expect that In aim 1 the study team will compare 129Xe MRI signatures to lung explant pathology cellular identity from single-cell RNA sequencing and cellular phenotypes in gas exchange defects to areas that are spared which the study team hypothesizes are exposed to lower levels of hemodynamic shear stress This will be done by performing 129Xe MRI scans in fifteen subjects cohort 1 with PAH awaiting a lung transplant followed by a pathologic assessment with usual histopathology and single-cell RNA sequencing of the subjects explanted lung after transplant The study team expect that areas of proliferation and fibrosis will correlate with 129Xe MRI gas exchange and spectroscopic defects
In aim 3 The study team will test whether directly monitoring lung pathology with 129Xe MRI will provide additional prognostic information to standard-of-care clinical monitoring in 45 subjects cohort 2 At 6-month follow-up appointments standard-of-care assessments including labs echocardiography and six-minute walk distance and 129Xe MRI will be collected The study team expect that In aim 1 the study team will compare 129Xe MRI signatures to lung explant pathology cellular identity from single-cell RNA sequencing and cellular phenotypes in gas exchange defects to areas that are spared which the study team hypothesizes are exposed to lower levels of hemodynamic shear stress This will be done by performing 129Xe MRI scans in fifteen subjects cohort 1 with PAH awaiting a lung transplant followed by a pathologic assessment with usual histopathology and single-cell RNA sequencing of the subjects explanted lung after transplant The study team expect that areas of proliferation and fibrosis will correlate with 129Xe MRI gas exchange and spectroscopic defects
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