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NCT Number: NCT06406777

Chronic Lung Allograft Dysfunction MRI 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

Location status: Recruiting

Location contact

Sean Fail, PhD

CONTACT

[email protected]

319-356-4832

About this 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.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Baseline and 3 months

    Absolute decrease of FEV1 by 20%

Study contacts

Contact information is provided by the study sponsor or research team.

Sean Fain, Ph.D.

CONTACT

[email protected]

319 356 4832

Sponsors and collaborators

Lead sponsor

Sean Fain

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 9, 2024
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.