Chronic Lung Allograft Dysfunction MRI Study

ConditionChronic Lung Allograft Dysfunction Lung MRI (CLAD)

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18-80

SponsorSean Fain

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Ages 18-80

English Speaking Subjects

Willingness and ability to provide informed consent

Non-smoker

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

Spirometry
Diagnostic test
Spirometry measures lung function, specifically the amount and/or speed of air that can be inhaled and exhaled.
Contrast Lung Computed Tomography (CT) Scan
Diagnostic test
CT scan of the lungs using contrast
Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan
Diagnostic test
MRI will be taken while subject is lying on their back breathing 100% oxygen.
129Xe MRI scans
Drug
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.

Treatment groups

100 Participants

are divided into 3 treatment groups

Group A: Healthy Normal SubjectsActive comparator 4 interventions

Group B: Post Lung Transplant with normal functioningExperimental treatment 4 interventions

Group C: Post Lung Transplant with Chronic Lung Allograft Dysfunction (CLAD)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

Forced expiratory volume in 1 second (FEV1) Decline

Absolute decrease of FEV1 by 20%

Time frame

Baseline and 3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sean Fain

Lead sponsor

University of Iowa

Sponsor institution

Source ClinicalTrials.gov

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