Chronic Lung Allograft Dysfunction Lung MRI (CLAD)
Conditions
Keywords
Lung Transplant
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.
Interventions
DIAGNOSTIC_TESTSpirometry
Spirometry measures lung function, specifically the amount and/or speed of air that can be inhaled and exhaled.
DIAGNOSTIC_TESTContrast Lung Computed Tomography (CT) Scan
CT scan of the lungs using contrast
DIAGNOSTIC_TESTOxygen enhanced magnetic resonance imaging (OE-MRI) Scan
MRI will be taken while subject is lying on their back breathing 100% oxygen.
DRUG129Xe MRI scans
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.
Sponsors
Sean Fain
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Three populations that will all have the same interventions.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
All subjects-Inclusion Criteria: * Ages 18-80 * English Speaking Subjects * Willingness and ability to provide informed consent * Non-smoker Lung transplant patients-inclusion criteria: * \>/= 6 months from lung transplant * History of bilateral lung transplant CLAD-free patients-inclusion criteria: * Stable spirometry with FEV1 \> 90% of baseline value (average of 2 best values) and forced mid-expiratory flow (FEF) (25-75) \> 75% of baseline * Total Lung Capacity (TLC) \> 90 % of baseline * Post-transplant chest radiograph without significant abnormality * No evidence of on-going lung infection or allograft rejection Early CLAD patients-inclusion criteria: * FEV1 \< 80% of baseline value (average of 2 best values) * Follow up 6-months or decline in lung function (20% decrease in FEV1 without evidence of infection or acute rejection)
Exclusion criteria
* SAO2 drops below 90% (in absence of mechanical failure) during normal tidal breathing * Unilateral diaphragm paralysis * Evidence of acute illness on day of study * Evidence of restrictive lung disease * Dependence on supplemental oxygen * History of cardiac disease * Pregnancy (self-declared) * Lactating women * Participants with metal objects in their body * Known contraindication to MRI examination * Systolic blood pressure reading of \< 100 mmHg or \> 200 mmHg * Diastolic blood pressure reading of \<60 mmHg or \> 100 mmHg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Forced expiratory volume in 1 second (FEV1) Decline | Baseline and 3 months | Absolute decrease of FEV1 by 20% |
Countries
United States
Contacts
CONTACTSean Fain, Ph.D.
PRINCIPAL_INVESTIGATORSean Fain, Ph.D
University of Iowa
Outcome results
None listed