MRI for Screening and Monitoring Systemic Sclerosis Interstitial Lung Disease
概览
- 阶段
- 不适用
- 干预措施
- HRCT
- 疾病 / 适应症
- Scleroderma
- 发起方
- University of Kansas Medical Center
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in RBC/Barrier Ratio
- 状态
- 已完成
- 最后更新
- 昨天
概览
简要总结
The purpose of this study is to test MRI methods for evaluating patients with Scleroderma-associated interstitial lung disease.
详细描述
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).
研究者
入排标准
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Scleroderma
Patients with Scleroderma will be imaged with UTE MRI to compare MRI with CT for identifying Interstitial Lung Disease
干预措施: HRCT
Scleroderma ILD
Patients with Scleroderma ILD who are initiating treatment will be imaged using hyperpolarized 129Xe MRI to assess treatment efficacy.
干预措施: MRI
Scleroderma ILD
Patients with Scleroderma ILD who are initiating treatment will be imaged using hyperpolarized 129Xe MRI to assess treatment efficacy.
干预措施: Hyperpolarized Xe129
Scleroderma
Patients with Scleroderma will be imaged with UTE MRI to compare MRI with CT for identifying Interstitial Lung Disease
干预措施: MRI
结局指标
主要结局
Change in RBC/Barrier Ratio
时间窗: 6 months
The change in hyperpolarized 129Xe RBC/Barrier ratio from baseline to follow-up imaging
Presence of ILD on CT and MRI
时间窗: Baseline
An experienced radiologist will review MRI and CT images to assess whether ILD is present.