SclerodermaNCT05204355
MRI for Screening and Monitoring Scleroderma ILD
An observational study of Scleroderma, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to test MRI methods for evaluating patients with Scleroderma-associated interstitial lung disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma
- What is being tested?
- MRI, Hyperpolarized Xe129 and HRCT
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 31 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
- Age ≥ 18 years of age
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- 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.
Who cannot join
- 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
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- 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)
- 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:
- Previous clinical or echocardiographic evidence of significant right heart failure
- History of right heart catheterization showing a cardiac index ≤ 2 l/min/m²
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: MRI for Screening and Monitoring Systemic Sclerosis Interstitial Lung Disease
The purpose of this study is to test MRI methods for evaluating patients with Scleroderma-associated interstitial lung disease.
Read the detailed description
- Quantify the sensitivity and specificity of UTE MRI in screening for scleroderma-associated interstitial lung disease. ILD is relatively common in SSc, but current clinical standards require screening using HRCT. UTE MRI can provide images of pulmonary structure with contrast and resolution approaching that of CT. We hypothesize that UTE MRI will have high sensitivity and specificity (>80%) to the presence of ILD as determined by HRCT. Aim
- Quantify treatment response in patients with SSc-ILD using hyperpolarized 129Xe MRI. The optimal treatment for SSc-ILD is not known, and it is challenging to assess the efficacy of therapy. Hyperpolarized 129Xe MRI is highly sensitive to the pathophysiology associated with ILD, which suggests that it may be more sensitive to treatment response than conventional methods. We hypothesize that hyperpolarized 129Xe MRI biomarkers will be sensitive to lung function improvement or decline earlier than standard clinical measures (6MWD, FVC, DLCO, Dyspnea score).
- Conditions
- Scleroderma
- Being tested
- MRI, Hyperpolarized Xe129, HRCT
- Medical subject headings
- Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Patients will be imaged using MRI
Hyperpolarized Xe129Drug
Hyperpolarized Xe129 will be used to image the lungs of a subset of participants.
HRCTDiagnostic test
High Resolution Computer Tomography
| Study group | Role | What they receive |
|---|---|---|
| Scleroderma | Patients with Scleroderma will be imaged with UTE MRI to compare MRI with CT for identifying Interstitial Lung Disease Receives: Diagnostic Test: MRI; Diagnostic Test: HRCT | |
| Scleroderma ILD | Patients with Scleroderma ILD who are initiating treatment will be imaged using hyperpolarized 129Xe MRI to assess treatment efficacy. Receives: Diagnostic Test: MRI; Drug: Hyperpolarized Xe129 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of ILD on CT and MRI
An experienced radiologist will review MRI and CT images to assess whether ILD is present.
Measured: Baseline
Change in RBC/Barrier Ratio
The change in hyperpolarized 129Xe RBC/Barrier ratio from baseline to follow-up imaging
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start1 May 2022
- Primary completion31 Mar 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Scleroderma Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204355
- Sponsor's protocol ID
- STUDY00148159
- Status last verified
- Apr 2026
- First submitted
- 10 Jan 2022
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI for Screening and Monitoring Systemic Sclerosis Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT05204355
- Acronym / sponsor ID
- STUDY00148159
- Conditions
- Scleroderma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Scleroderma Foundation
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test MRI methods for evaluating patients with Scleroderma-associated interstitial lung disease.
Detailed description
- Quantify the sensitivity and specificity of UTE MRI in screening for scleroderma-associated interstitial lung disease. ILD is relatively common in SSc, but current clinical standards require screening using HRCT. UTE MRI can provide images of pulmonary structure with contrast and resolution approaching that of CT. We hypothesize that UTE MRI will have high sensitivity and specificity (>80%) to the presence of ILD as determined by HRCT. Aim
- Quantify treatment response in patients with SSc-ILD using hyperpolarized 129Xe MRI. The optimal treatment for SSc-ILD is not known, and it is challenging to assess the efficacy of therapy. Hyperpolarized 129Xe MRI is highly sensitive to the pathophysiology associated with ILD, which suggests that it may be more sensitive to treatment response than conventional methods. We hypothesize that hyperpolarized 129Xe MRI biomarkers will be sensitive to lung function improvement or decline earlier than standard clinical measures (6MWD, FVC, DLCO, Dyspnea score).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scleroderma | – | Diagnostic Test: MRI, Diagnostic Test: HRCTPatients with Scleroderma will be imaged with UTE MRI to compare MRI with CT for identifying Interstitial Lung Disease |
| Scleroderma ILD | – | Diagnostic Test: MRI, Drug: Hyperpolarized Xe129Patients with Scleroderma ILD who are initiating treatment will be imaged using hyperpolarized 129Xe MRI to assess treatment efficacy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIPatients will be imaged using MRI | Diagnostic test | Scleroderma, Scleroderma ILD |
| Hyperpolarized Xe129Hyperpolarized Xe129 will be used to image the lungs of a subset of participants. | Drug | Scleroderma ILD |
| HRCTHigh Resolution Computer Tomography | Diagnostic test | Scleroderma |
Primary outcome
Presence of ILD on CT and MRI
Time frame: Baseline
An experienced radiologist will review MRI and CT images to assess whether ILD is present.
Change in RBC/Barrier Ratio
Time frame: 6 months
The change in hyperpolarized 129Xe RBC/Barrier ratio from baseline to follow-up imaging
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scleroderma, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of ILD on CT and MRI (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.