Quantification of Calcinosis Cutis Disease Burden in Patients With Systemic Sclerosis Using Computed Tomography Images
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Modified Mawdsley Calcinosis Questionnaire (mMCQ)
研究概览
简要总结
The main purpose of this study is to develop sensitive radiographic measurement techniques that can be used as outcome measures along with patient-reported outcome instruments in clinical trials of calcinosis cutis treatments, and potentially be used to assess disease course and treatment response in clinical practice. The goal is to test the performance of the software.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scleroderma/systemic sclerosis patient with diagnosed calcinosis cutis who will be clinically treated with STS as they would in clinical SOC care
- •Must be ≥ 18 years old and meet the 2013 American College of Rheumatology criteria for the diagnosis of systemic sclerosis (diffuse or limited)
- •Receiving clinical care at Yale clinics
排除标准
- •Unable to provide informed consent
- •Currently pregnant or nursing
- •Patients with a calcinosis ROI >6cm
研究组 & 干预措施
Systemic sclerosis participants with calcinosis
SSc participants with calcinosis treated with sodium thiosulfate STS per SOC over 6 months.
干预措施: Sodium Thiosulfate (STS) (Drug)
Systemic sclerosis participants with calcinosis
SSc participants with calcinosis treated with sodium thiosulfate STS per SOC over 6 months.
干预措施: Sodium Thiosulfate Injection (Drug)
结局指标
主要结局
Modified Mawdsley Calcinosis Questionnaire (mMCQ)
时间窗: Baseline, 3 months and 6 months
An 18-question survey with an overall score of 0-10; each individual question ranges from 0-10, scores are totaled and averaged to and divided by 18 to create the overall score. Higher scores indicate higher disability from calcinosis.
CT imaging measure
时间窗: Baseline, 3 months and 6 months
BioImageSuite Web will be used to measure the CT scan volumes. The measurements are quantified using voxel annotation and built-in computation software. The volume of each scan will be recorded.
Calcinosis VAS
时间窗: Baseline, 3 months and 6 months
Used to measure the severity of calcinosis-related pain or symptoms. Scored 0-100 with higher scores indicating greater severity.
次要结局
- Correlation between the change in the mMCQ scores and the CT imaging measures(Baseline, 3 months and 6 months)