Recruiting
Phase 1
Phase 2

OE-MRI, MRI & CT

Sponsor:

Sean Fain

Code:

NCT06406777

Conditions

Chronic Lung Allograft Dysfunction Lung MRI (CLAD)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Spirometry

Contrast Lung Computed Tomography (CT) Scan

Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan

129Xe MRI scans

Study Details

Brief 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.

Conditions

Chronic Lung Allograft Dysfunction Lung MRI (CLAD)

Study ID

NCT06406777

Start date

Mar 20, 2025

Status verified date

Apr, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Healthy Normal Subjects

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

experimental: Post Lung Transplant with normal functioning

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

experimental: Post Lung Transplant with Chronic Lung Allograft Dysfunction (CLAD)

Subjects who have had a lung transplant that now have CLAD

Interventions

Spirometry

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

Contrast Lung Computed Tomography (CT) Scan

CT scan of the lungs using contrast

Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan

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

129Xe 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.

Primary outcome measure

  • Forced expiratory volume in 1 second (FEV1) Decline [ Time Frame: Baseline and 3 months ]

Central Contacts and Locations

Central contacts

Sean Fain, Ph.D.

319 356 4832sean-fain@uiowa.edu

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Sean Fail, PhD

319-356-4832sean-fain@uiowa.edu

More Information

Sponsor

Sean Fain

Last update posted

Aug 6, 2026

Last verified

Apr, 2026

Keywords

  • Lung Transplant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sean Fain on 2026-08-06.