Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06406777
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-05-06
Brief Title:
Chronic Lung Allograft Dysfunction MRI Study
Sponsor:
Sean Fain
Organization:
University of Iowa
Study Overview
Official Title:
Validation of MRI CT and Pulmonary Function Tests for Early Detection of Chronic Lung Allograft Dysfunction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 studies purpose is to confirm the efficacy and efficiency of using OE-MRI and MRI with hyperpolarized gas techniques and Iodinated contrast CT scan this will enhance understanding of CLAD pathophysiology Moreover this project is foundational to performing additional studies to establish if novel MRI imaging can serve as an objective confirmatory diagnostic tool for CLAD in post-transplant patients
Detailed Description:
This studies purpose is to confirm the efficacy and efficiency of using OE-MRI and MRI with hyperpolarized gas techniques and Iodinated contrast CT scan this will enhance understanding of CLAD pathophysiology Moreover this project is foundational to performing additional studies to establish if novel MRI imaging can serve as an objective confirmatory diagnostic tool for CLAD in post-transplant patients
This observational imaging study will use 3T UTE MRI with varying oxygen levels room air vs 100 oxygen to evaluate lung ventilation using oxygen enhanced imaging in 50 healthy normal subjects age 18-80
Subjects will have vital signs taken complete questionnaires and have pulmonary function test spirometry done Iodinated contrast CT scan and standard of care CT scans in addition to one MRI session that will include 6 series of scans The MRI scans will be taken in supine position laying on back and include breathing room air and 100 oxygen OE-MRI will be done in addition to MRI scans with Xenon-129
This observational imaging study will use 3T UTE MRI with varying oxygen levels room air vs 100 oxygen to evaluate lung ventilation using oxygen enhanced imaging in 50 healthy normal subjects age 18-80
Subjects will have vital signs taken complete questionnaires and have pulmonary function test spirometry done Iodinated contrast CT scan and standard of care CT scans in addition to one MRI session that will include 6 series of scans The MRI scans will be taken in supine position laying on back and include breathing room air and 100 oxygen OE-MRI will be done in addition to MRI scans with Xenon-129
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None