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Can new scans catch lung transplant failure before It's too late?

NCT ID NCT06406777

Diagnosis Sponsor: Sean Fain Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This study tests whether advanced imaging techniques, including oxygen-enhanced MRI and hyperpolarized xenon MRI, can detect chronic lung allograft dysfunction (CLAD) earlier than standard lung function tests. CLAD is a common complication after lung transplantation that can lead to organ failure. The study will compare these imaging methods with spirometry and CT scans in lung transplant recipients and healthy volunteers. The goal is to see if these scans can provide a more accurate and earlier diagnosis, which could help guide treatment and improve outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Diagnostic imaging tests: spirometry, contrast CT scan, oxygen-enhanced MRI, and hyperpolarized xenon (129Xe) MRI
What this could lead to
If successful, these imaging techniques could provide a more accurate and earlier diagnosis of chronic lung allograft dysfunction, potentially improving treatment timing and outcomes for lung transplant recipients.
What could go wrong
This is an early-stage study, and the imaging methods may not prove more effective than current standard tests. There are also risks associated with contrast agents and radiation exposure from CT scans.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

transplant-related bronchiolitis obliterans

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic lung allograft dysfunction lung mri (CLAD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

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