New MRI method could spot lung damage without radiation
NCT ID NCT05204355
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
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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
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18 years and older
- Sex
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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 Hide 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
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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.
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