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New MRI method could spot lung damage without radiation

NCT ID NCT05204355

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether MRI can detect and monitor interstitial lung disease (lung scarring) in people with scleroderma. Twenty-five adults with scleroderma underwent both MRI and CT scans. A subset also breathed in a special xenon gas to see how well their lungs exchange oxygen. The goal was to see if MRI could replace CT scans, which use radiation.

What this could mean

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

Active substance
MRI and hyperpolarized xenon gas
What this could lead to
If successful, MRI could become a safer, radiation-free way to detect and track lung scarring in scleroderma patients.
What could go wrong
This is a small, completed study with only 25 participants. MRI may not be as accurate as CT scans, and results may not apply to all patients.

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.

Participants

25 people

The number who actually took part.

Started

May 2022

Finished

Oct 2025

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.

Who is studied

Patients to be enrolled will have Scleroderma. Patients will be enrolled in either or both of arms 1 and 2: Arm 1: Patients with scleroderma who undergo a clinical CT scan to screen for ILD. Arm 2: Patients with scleroderma ILD who are initiating treatment for the first time.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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.

Arm 1 (UTE MRI in patients with Scleroderma) Inclusion Criteria: * Age ≥ 18 years of age * Subject has clinical diagnosis of scleroderma. * Chest CT scan within 1 month prior to screening or Chest CT scan will be completed within 1 month post study enrollment. * Ability to adhere to the study visit schedule, adhere, and comply with all protocol requirements. * Ability to understand and provide written informed consent. Exclusion Criteria: * Subject unable to undergo MRI based on MRI safety screening * Pregnant or breastfeeding female subjects * Prisoners or incarcerated individuals * Any in-patient hospitalization (defined as greater than 23 hours) within 30 days of study enrollment * Any major surgical procedure within 90 days prior to study enrollment or planned surgical procedure during the study period. * Concomitant medical disorder, condition, or history, that in the opinion of the Investigator would impair the subject's ability to participate in or complete the requirements of the study * Other medical or psychiatric condition which, in the opinion of the Investigator, would place the subject at increased risk or would preclude obtaining voluntary consent or would confound the objectives of the study Arm 2 (Hyperpolarized 129Xe MRI in Patients with Scleroderma ILD) Inclusion Criteria: * Age ≥ 18 years of age * Subject clinically diagnosed with SSc-ILD. * Subject initiating background SSc-ILD therapy within ±30 days of visit 1. (i.e. patient cannot have begun therapy for SSc-ILD more than 30 days prior to visit 1, or must be clinically scheduled to initiate therapy within 30 days after visit 1). * FVC % Predicted ≥45% pre-bronchodilator within 30 days prior to screening or at baseline. * DLCO % Predicted ≥30% within 30 days prior to screening or at baseline. * Oxygen saturation \>87% on room air or with supplemental oxygen * Ability to adhere to the study visit schedule, adhere, and comply with all protocol requirements. * Ability to understand and provide written informed consent. Exclusion Criteria: * Subject unable to undergo MRI based on MRI safety screening * Diagnosis of IPF based on ATS/ERS/JRS/ALAT 2018 Guidelines * Significant Pulmonary Arterial Hypertension (PAH) defined by any of the following: 1. Previous clinical or echocardiographic evidence of significant right heart failure 2. History of right heart catheterization showing a cardiac index ≤ 2 l/min/m² 3. PAH requiring parenteral therapy with epoprostenol/treprostinil * Primary obstructive airway physiology (pre-bronchodilator FEV1/FVC \< 0.7 at Baseline). * Pregnant or breastfeeding female subjects * Prisoners or incarcerated individuals * Any in-patient hospitalization (defined as greater than 23 hours) within 30 days of study enrollment * Any major surgical procedure within 90 days prior to study enrollment or planned surgical procedure during the study period. * Concomitant medical disorder, condition, or history, that in the opinion of the Investigator would impair the subject's ability to participate in or complete the requirements of the study * Other medical or psychiatric condition which, in the opinion of the Investigator, would place the subject at increased risk or would preclude obtaining voluntary consent or would confound the objectives of the study * Subject has been on therapy for SSc-ILD for \>30 days prior to baseline MRI. * Pregnancy (Visit 1 or Visit 2) or intention to become pregnant (Visit 2 only)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.