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RecruitingAccepts healthy volunteersPhase 1/Phase 2

Chronic Lung Allograft Dysfunction MRI Study

Sean Fain · NCT06406777

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–80 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1, Phase 2
Target enrollment
100
US sites recruiting
1
Study start
March 20, 2025
Record last updated
August 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Spirometry; Contrast Lung Computed Tomography (CT) Scan; Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan; 129Xe MRI scans

Conditions: Chronic Lung Allograft Dysfunction Lung MRI (CLAD)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • University of Iowa

    Iowa City, IA 52242

    Site contact: Sean Fail, PhD · 319-356-4832 · sean-fain@uiowa.edu

Study contacts (from the official record)

  • Sean Fain, Ph.D. · 319 356 4832 · sean-fain@uiowa.edu
All healthy volunteers studies in Iowa →
Chronic Lung Allograft Dysfunction MRI Study (NCT06406777) | Bored Studies