Chronic Lung Allograft Dysfunction MRI Study

This study is looking at new ways to understand Chronic Lung Allograft Dysfunction (CLAD), a lung problem that can happen after a lung transplant. Researchers want to see if special MRI scans, including Oxygen enhanced magnetic resonance imaging (OE-MRI) and 129Xe MRI scans, along with a Contrast Lung Computed Tomography (CT) Scan, can help diagnose CLAD. The main goal is to see if these imaging methods can show changes in your lung function, specifically your Forced expiratory volume in 1 second (FEV1), over three months. You might be able to join if you are 18-80 years old, speak English, are a non-smoker, and have had a bilateral lung transplant at least 6 months ago. The study is currently recruiting 100 participants.

Study design
This interventional study plans to enroll 100 participants to evaluate different imaging techniques.
What's involved
You will have vital signs taken, complete questionnaires, undergo spirometry (a breathing test), a Contrast Lung CT Scan, and one MRI session with six different scans, including OE-MRI and 129Xe MRI.
Compensation
Not stated in the trial record.
Follow-up
Your FEV1 will be measured at the beginning of the study and again after 3 months.

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NCT06406777

Chronic Lung Allograft Dysfunction MRI Study

Recruiting
PHASE1Ages 18–80InterventionalDiagnostic
Sean Fain
~100 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:SpirometryContrast Lung Computed Tomography (CT) ScanOxygen enhanced magnetic resonance imaging (OE-MRI) Scan129Xe MRI scans

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Forced expiratory volume in 1 second (FEV1) Decline
Measured over Baseline and 3 months
Chronic Lung Allograft Dysfunction Lung MRI (CLAD)
1 sites across 1 states
Iowa1
  • Sean Fain, Ph.D · PRINCIPAL_INVESTIGATOR · University of Iowa

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Eligibility criteria

Inclusion

Ages 18-80
English Speaking Subjects
Willingness and ability to provide informed consent
Non-smoker
\>/= 6 months from lung transplant
History of bilateral lung transplant
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
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

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
  • Forced expiratory volume in 1 second (FEV1) DeclineBaseline and 3 months

    Absolute decrease of FEV1 by 20%