Validation of MRI, CT and Pulmonary Function Tests for Early Detection of Chronic Lung Allograft Dysfunction
Overview
- Phase
- Phase 1
- Intervention
- Spirometry
- Conditions
- Chronic Lung Allograft Dysfunction Lung MRI (CLAD)
- Sponsor
- Sean Fain
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Forced expiratory volume in 1 second (FEV1) Decline
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Sean Fain
Professor
University of Iowa
Eligibility Criteria
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
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
Arms & Interventions
Healthy Normal Subjects
Healthy subjects, with no lung diagnosis, who are non-smokers.
Intervention: Spirometry
Healthy Normal Subjects
Healthy subjects, with no lung diagnosis, who are non-smokers.
Intervention: Contrast Lung Computed Tomography (CT) Scan
Healthy Normal Subjects
Healthy subjects, with no lung diagnosis, who are non-smokers.
Intervention: Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan
Healthy Normal Subjects
Healthy subjects, with no lung diagnosis, who are non-smokers.
Intervention: 129Xe MRI scans
Post Lung Transplant with normal functioning
Subjects who have had a lung transplant and now have normal lung function
Intervention: Spirometry
Post Lung Transplant with normal functioning
Subjects who have had a lung transplant and now have normal lung function
Intervention: Contrast Lung Computed Tomography (CT) Scan
Post Lung Transplant with normal functioning
Subjects who have had a lung transplant and now have normal lung function
Intervention: Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan
Post Lung Transplant with normal functioning
Subjects who have had a lung transplant and now have normal lung function
Intervention: 129Xe MRI scans
Post Lung Transplant with Chronic Lung Allograft Dysfunction (CLAD)
Subjects who have had a lung transplant that now have CLAD
Intervention: Spirometry
Post Lung Transplant with Chronic Lung Allograft Dysfunction (CLAD)
Subjects who have had a lung transplant that now have CLAD
Intervention: Contrast Lung Computed Tomography (CT) Scan
Post Lung Transplant with Chronic Lung Allograft Dysfunction (CLAD)
Subjects who have had a lung transplant that now have CLAD
Intervention: Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan
Post Lung Transplant with Chronic Lung Allograft Dysfunction (CLAD)
Subjects who have had a lung transplant that now have CLAD
Intervention: 129Xe MRI scans
Outcomes
Primary Outcomes
Forced expiratory volume in 1 second (FEV1) Decline
Time Frame: Baseline and 3 months
Absolute decrease of FEV1 by 20%