MRI for Screening and Monitoring Scleroderma ILD

Launched by UNIVERSITY OF KANSAS MEDICAL CENTER · Jan 10, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the use of MRI (a type of imaging test) to help doctors better understand and monitor lung problems in patients with scleroderma, a condition that can affect the skin and internal organs. The goal is to see how effective different MRI methods are in evaluating lung disease associated with scleroderma, known as interstitial lung disease (ILD). The trial is currently looking for participants aged 18 and older who have been diagnosed with scleroderma and have had a recent chest CT scan.

To participate, individuals must be able to attend scheduled visits and provide informed consent. Participants will undergo MRI scans and may need to start a new treatment for their lung disease during the study. It’s important to note that certain individuals, such as those who are pregnant, have specific heart or lung conditions, or have recently had major surgery, may not be eligible. Overall, this study aims to find better ways to assess lung health in people with scleroderma, potentially leading to improved care and treatment options.

Gender

ALL

Eligibility criteria

• • 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)