Status:
ACTIVE_NOT_RECRUITING
MRI for Screening and Monitoring Scleroderma ILD
Lead Sponsor:
University of Kansas Medical Center
Collaborating Sponsors:
Scleroderma Foundation
Conditions:
Scleroderma
Eligibility:
All Genders
18+ years
Brief 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 screen...
Eligibility Criteria
Inclusion
- Arm 1 (UTE MRI in patients with Scleroderma)
- 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
- 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.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05204355
Start Date
May 1 2022
End Date
October 31 2025
Last Update
April 2 2025
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160