Acoustic Radiation Force Impulse/Shear Wave Velocity Imaging of the Skin in Scleroderma and Other Rheumatologic Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Mean Skin Stiffness
研究概览
简要总结
Scleroderma and other rheumatologic conditions can affect the skin. Scleroderma in particular involves skin thickening and hardening.
Currently, looking at the degree that the skin is affected by scleroderma is measured based on a combination of a physical exam and a skin biopsy.
The researchers propose to measure skin hardness using ultrasound imaging of elasticity. They will use a technique using acoustic radiation force impulse/shear wave velocity imaging , known as ARFI/SVI).
The investigators hypothesize that ARFI/SVI may be able to distinguish between normal skin and skin affected by scleroderma.. This tool may also help to quantify the amount of fibrosis in the skin.
This type of radiologic biomarker could be used to help confirm the diagnosis of scleroderma.
详细描述
Scleroderma as well as numerous other rheumatologic conditions can affect the skin. Scleroderma in particular causes skin thickening and hardening.
Currently, evaluation of degree to which skin is affected by scleroderma is measured by a combination of a physical exam and skin biopsy results.
The investigators propose to measure skin hardness using ultrasound elasticity imaging, in the form of acoustic radiation force impulse/shear wave velocity imaging (ARFI/SVI).
The investigators hypothesize that ARFI/SVI may be able to distinguish normal skin from skin affected by scleroderma (and other rheumatologic conditions). And, this ultrasound technique might measure the amount of fibrosis in the dermis (skin).
Such a radiologic biomarker could be used to help confirm the diagnosis of scleroderma. In addition, it may be usable for following patients over time and measuring their response to therapy and progression of disease.
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
- 是
入选标准
- •18 years of age or older
- •Rheumatologic disease of the skin including: Limited Scleroderma, Diffuse Scleroderma, or Eosinophilic Fascitis (Schulman's Syndrome)
排除标准
- 未提供
结局指标
主要结局
Mean Skin Stiffness
时间窗: Cross-sectional study, 1 visit, <1 hr
Skin stiffness was measured from the forearm and thigh of patients with scleroderma using ultrasound shear wave velocity imaging. Shear wave velocity is measured in meters per second (m/s).
次要结局
- Mean Skin Stiffness as Measured by Durometer Scoring(Cross-sectional study, 1 visit, <1 hr)
- Linear Relationship Between Ultrasound Skin Stiffness and MRSS(Cross-sectional study, 1 visit, <1 hr)
- Linear Relationship Between Ultrasound Skin Stiffness and Durometer(Cross-sectional study, 1 visit, <1 hr)
- Mean Landmark Scores(Cross-sectional study, 1 visit, <1 hr)
- Linear Relationship Between Ultrasound Skin Stiffness and Landmark(Cross-sectional study, 1 visit, <1 hr)
- MRSS Scores for Scleroderma Participants.(Cross-sectional study, 1 visit, <1 hr)
研究者
Dinesh Khanna, MD, MS
Principal Investigator
University of Michigan