MRI techniques for assessing lung transplant health
Official title: Validation of MRI, CT and Pulmonary Function Tests for Early Detection of Chronic Lung Allograft Dysfunction
Run by University of Iowa · NCT06406777 · Data updated 2026-11-12
This study is testing new MRI techniques to see if they can help doctors better understand lung health in people who have had a lung transplant.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of Iowa Academic / other |
| Locations | 1 site (Iowa City, Iowa) |
| Status | Recruiting |
| Started | March 20, 2025 |
| Main results expected | September 2028 |
| Study ends | September 2028 |
| Registry record updated | August 6, 2026 |
| Trial ID | NCT06406777 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include lung transplant patients who are at least six months post-transplant and have a history of bilateral lung transplant, as well as healthy individuals aged 18-80.
✕Probably not a fit
Patients who are current smokers or have significant lung infections or allograft rejection may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of oxygen-enhanced MRI (OE-MRI) and hyperpolarized gas MRI techniques, alongside iodinated contrast CT scans, to better understand chronic lung allograft dysfunction (CLAD) in lung transplant patients. It will involve healthy subjects and lung transplant recipients, assessing lung ventilation under different oxygen levels. The findings could pave the way for using novel MRI imaging as a diagnostic tool for CLAD, enhancing patient management post-transplant.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive diagnostic tool for early detection of chronic lung allograft dysfunction in lung transplant patients.
How similar studies have gone: While the use of advanced MRI techniques in lung imaging is promising, this specific approach to diagnosing CLAD is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University of Iowa
Iowa City, Iowa, United States Recruiting
Study contacts
- Principal investigator: Sean Fain, Ph.D — University of Iowa
- Study coordinator: Sean Fain, Ph.D.
- Email: sean-fain@uiowa.edu
- Phone: 319 356 4832
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.