MRI for Screening and Monitoring Scleroderma ILD

NCT05204355 | Completed FDA Drug

• 1 other identifier: STUDY00148159
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test MRI methods for evaluating patients with Scleroderma-associated interstitial lung disease.

Conditions

Scleroderma

Outcome Measures

Primary Outcomes (2)

• Presence of ILD on CT and MRI

  An experienced radiologist will review MRI and CT images to assess whether ILD is present.

  Baseline

• Change in RBC/Barrier Ratio

  The change in hyperpolarized 129Xe RBC/Barrier ratio from baseline to follow-up imaging

  6 months

Study Arms (2)

Scleroderma

Patients with Scleroderma will be imaged with UTE MRI to compare MRI with CT for identifying Interstitial Lung Disease

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.

Diagnostic Test: MRI; Drug: Hyperpolarized Xe129

Interventions

MRI DIAGNOSTIC_TEST

Patients will be imaged using MRI

Scleroderma; Scleroderma ILD

Hyperpolarized Xe129 DRUG

Hyperpolarized Xe129 will be used to image the lungs of a subset of participants.

Scleroderma ILD

HRCT DIAGNOSTIC_TEST

High Resolution Computer Tomography

Scleroderma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Scleroderma Foundation: collaborator
• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 24, 2022
• Study Start: May 1, 2022
• Primary Completion: March 31, 2025
• Study Completion: October 31, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)