University of Iowa
Iowa City, Iowa, 52242, United States
Location status: Recruiting
NCT Number: NCT06406777
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 1 / Phase 2
Iowa City, Iowa, 52242, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
All subjects-Inclusion Criteria:
Lung transplant patients-inclusion criteria:
CLAD-free patients-inclusion criteria:
Early CLAD patients-inclusion criteria:
Exclusion criteria
Spirometry measures lung function, specifically the amount and/or speed of air that can be inhaled and exhaled.
CT scan of the lungs using contrast
MRI will be taken while subject is lying on their back breathing 100% oxygen.
MRI will be taken while subject is lying on their back breathing room oxygen and taking a breath of 129Xe and holding it for a few seconds.
Time frame: Baseline and 3 months
Absolute decrease of FEV1 by 20%
Contact information is provided by the study sponsor or research team.
Sean Fain
Other
Validation of MRI, CT and Pulmonary Function Tests for Early Detection of Chronic Lung Allograft Dysfunction
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.