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Chronic Lung Allograft Dysfunction MRI Study

RecruitingPhase 1/2Healthy volunteers welcome

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

Who can join

Ages 18 to 80 · All sexes · Healthy volunteers welcome

Full 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

About the 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 serve as an objective confirmatory diagnostic tool for CLAD in post-transplant patients.

What is being tested

Sponsor: Sean Fain · Participants: 100 · Started: Mar 20, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06406777

Locations in the U.S.

IowaUniversity of Iowa, Iowa City

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.