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RecruitingNCT06406777Updated Aug 6, 2026

Chronic Lung Allograft Dysfunction MRI Study

A Phase 1/2 interventional study of Spirometry and Contrast Lung Computed Tomography (CT) Scan in Chronic Lung Allograft Dysfunction Lung MRI (CLAD), sponsored by Sean Fain. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-06.

Sponsored by Sean Fain · Phase 1/2, Interventional, and Diagnostic

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 6 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

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.

This observational imaging study will use 3T UTE MRI with varying oxygen levels (room air vs. 100% oxygen) to evaluate lung ventilation using oxygen enhanced imaging, in 50 healthy normal subjects (age 18-80).

Subjects will have vital signs taken, complete questionnaires and have pulmonary function test (spirometry) done, Iodinated contrast CT scan and standard of care CT scans, in addition to one MRI session that will include 6 series of scans. The MRI scans will be taken in supine position (laying on back) and include breathing room air and 100% oxygen. OE-MRI will be done in addition to MRI scans with Xenon-129.

02

Conditions studied

  • Chronic Lung Allograft Dysfunction Lung MRI (CLAD)

Keywords

  • Lung Transplant
03

In context

Lead sponsor

Sean Fain is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Healthy Normal Subjects

    Healthy subjects, with no lung diagnosis, who are non-smokers.

    Diagnostic Test: Spirometry · Diagnostic Test: Contrast Lung Computed Tomography (CT) Scan · Diagnostic Test: Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan · Drug: 129Xe MRI scans

  • Experimental
    Post Lung Transplant with normal functioning

    Subjects who have had a lung transplant and now have normal lung function

    Diagnostic Test: Spirometry · Diagnostic Test: Contrast Lung Computed Tomography (CT) Scan · Diagnostic Test: Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan · Drug: 129Xe MRI scans

  • Experimental
    Post Lung Transplant with Chronic Lung Allograft Dysfunction (CLAD)

    Subjects who have had a lung transplant that now have CLAD

    Diagnostic Test: Spirometry · Diagnostic Test: Contrast Lung Computed Tomography (CT) Scan · Diagnostic Test: Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan · Drug: 129Xe MRI scans

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.

06

What researchers measure

Primary outcomes

  1. Forced expiratory volume in 1 second (FEV1) Decline

    Absolute decrease of FEV1 by 20%

    Time frame: Baseline and 3 months

07

Study locations

1 of 1 sites recruiting
  • University of Iowa
    Iowa City, Iowa 52242, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06406777
Lead sponsor
Sean Fain
Responsible party
Sean Fain (Professor, University of Iowa) — Sponsor-investigator
First posted
May 9, 2024
Start date
Mar 20, 2025
Primary completion
Sep 2028 (estimated)
Completion
Sep 2028 (estimated)
Last update
Aug 6, 2026

Study contacts

Sean Fain, Ph.D.
Contact
sean-fain@uiowa.edu
319 356 4832
Sean Fain, Ph.D
principal investigator · University of Iowa

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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