Trials / Active Not Recruiting
Active Not RecruitingNCT05204355
MRI for Screening and Monitoring Scleroderma ILD
MRI for Screening and Monitoring Systemic Sclerosis Interstitial Lung Disease
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 25 (actual)
- Sponsor
- University of Kansas Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to test MRI methods for evaluating patients with Scleroderma-associated interstitial lung disease.
Detailed description
1. 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 2. 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
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | MRI | Patients will be imaged using MRI |
| DRUG | Hyperpolarized Xe129 | Hyperpolarized Xe129 will be used to image the lungs of a subset of participants. |
| DIAGNOSTIC_TEST | HRCT | High Resolution Computer Tomography |
Timeline
- Start date
- 2022-05-01
- Primary completion
- 2025-03-31
- Completion
- 2025-10-31
- First posted
- 2022-01-24
- Last updated
- 2025-04-02
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05204355. Inclusion in this directory is not an endorsement.