Elastography Ultrasound in Localized Scleroderma (Morphea): a Prospective, Longitudinal, Multicentric Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Skin stiffness
研究概览
简要总结
Localized scleroderma (LS) is a skin disease that can cause complications such as disfigurement and limitation of mobility. Treatment for LS should be initiated early in the disease, as late-stage scleroderma does not respond well to treatment. Objective tools for diagnosis and follow-up of treatment for LS are not available clinically and are urgently needed. A new non-invasive ultrasound technique called "elastography" measures stiffness of tissues and holds potential for providing objective measures for follow-up of treatment of LS in children and adolescents. The team plans to conduct a multicenter study in North America to determine whether elastography ultrasound can show changes in skin stiffness for a period of 9 to 12 months after initiation of treatment for LS. This novel technology may add information to the existing imperfect clinical tools, thus improving the way therapy is offered to patients with LS.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Boys and girls 0-18 years of age at the time of disease onset with a new or existing diagnosis of localized scleroderma (LS) confirmed by a pediatric rheumatologist or dermatologist.
- •Presents with one active or inactive lesion, using the contralateral site for comparison at each visit, as long as the same lesion is evaluated at each time point. OR Presents with more than one lesion as far as both lesions are active or inactive.
- •Able to cooperate with clinical and US evaluation, and the parent or guardian is able to fill out interim patient history form.
排除标准
- •Patients with other co-morbidities (e.g. systemic sclerosis, juvenile idiopathic arthritis, other systemic diseases).
- •Patients who present with one active and one inactive lesion.
- •Patients with lesions located in the face or head.
结局指标
主要结局
Skin stiffness
时间窗: Baseline, 3-6m and 9-12m
Skin stiffness will be assessed using Elastography (SWE) Ultrasound, a sonographic technique that uses mechanical waves to assess tissue elasticity and display it in a quantitative manner. The stiffness of the tissue is directly proportional to its shear wave velocity. SWE will measure interval changes of skin stiffness during treatment at the target lesion and the unaffected contralateral site.
次要结局
- Lesion activity responsiveness(Baseline, 3-6m and 9-12m)
- Echogenicity scores for dermis and hypodermis(Baseline, 3-6m and 9-12m)
- Vascularity scores for dermis and hypodermis(Baseline, 3-6m and 9-12m)
- Quality of Life(Baseline, 3-6m and 9-12m)
研究者
Andrea Doria
Professor, Vice-Chair of Radiology (Clinical Practice Improvement), Department of Medical Imaging, University of Toronto Radiologist, Senior Scientist, Research Director, Department of Diagnostic Imaging
The Hospital for Sick Children