RecruitingPhase 1Phase 2NCT06406777

Chronic Lung Allograft Dysfunction MRI Study

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

Sponsor

Sean Fain

Enrollment

100 participants

Start Date

Mar 20, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Lung Allograft Dysfunction Lung MRI (CLAD)

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria12

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 Criteria12

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

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Interventions

DIAGNOSTIC_TESTSpirometry

Spirometry measures lung function, specifically the amount and/or speed of air that can be inhaled and exhaled.

DIAGNOSTIC_TESTContrast Lung Computed Tomography (CT) Scan

CT scan of the lungs using contrast

DIAGNOSTIC_TESTOxygen enhanced magnetic resonance imaging (OE-MRI) Scan

MRI will be taken while subject is lying on their back breathing 100% oxygen.

DRUG129Xe MRI scans

MRI will be taken while subject is lying on their back breathing room oxygen and taking a breath of 129Xe and holding it for a few seconds.

Locations(1)

University of Iowa

Iowa City, Iowa, United States

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NCT06406777