MRI techniques for assessing lung transplant health

Validation of MRI, CT and Pulmonary Function Tests for Early Detection of Chronic Lung Allograft Dysfunction

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
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University of Iowa (other)
• Locations: 1 site (Iowa City, Iowa)
• Trial ID: NCT06406777 on ClinicalTrials.gov

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.

Who should consider this trial

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.

Not a fit: Patients who are current smokers or have significant lung infections or allograft rejection may not benefit from this study.

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 performed: 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.

Eligibility 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 this trial is running

Iowa City, Iowa

• 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.

Conditions: Chronic Lung Allograft Dysfunction Lung MRI, Lung Transplant