Chronic Lung Allograft Dysfunction MRI Study
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
| Condition(s) | Chronic Lung Allograft Dysfunction Lung MRI (CLAD) |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 with |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Sean Fain |
| Locations | Iowa City, Iowa, United States |
| Start date | 2025-03-20 |
| NCT ID | NCT06406777 |
| Official listing | https://clinicaltrials.gov/study/NCT06406777 |