New Biomarkers in Facioscapulohumeral Muscular Dystrophy, Multispectral Optoacoustic Tomography.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Optoacoustic Absorption Spectrum (peaks at different wavelengths in arbitrary units) in FSHD muscles
研究概览
简要总结
Facioscapulohumeral Muscular Dystrophy (FSHD) is one of the most frequent muscular dystrophies in the adulthood. Multi-spectral optoacoustic tomography (MSOT) is an innovative imaging technique able to non-invasively characterize the molecular composition of the muscle tissue. With this pilot study we will explore the performance of MSOT imaging in FSHD patients and correlate the findings with clinical and MRI data, with the final aim to identify new disease biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •molecular diagnosis of FSHD
- •recent pelvic and lower-limb muscle MRI
排除标准
- •presence of conditions that can alter the signal of the muscles under investigation: eg. tattoos, scars or skin abrasions at the site of probe evaluation, recent trauma, decompensated diabetes, symptomatic radiculopathies, acute or chronic inflammatory diseases
- •current or presumed pregnancy
- •inability to give informed consent
结局指标
主要结局
Optoacoustic Absorption Spectrum (peaks at different wavelengths in arbitrary units) in FSHD muscles
时间窗: 6 months
Definition of the Optoacoustic Absorption Spectrum (glycogen, lipid, collagen, hemo/myoglobin peaks at different wavelengths in arbitrary units) of muscles of FSHD patients and evaluation of the differences compared to healthy volunteers.
次要结局
- Disease severity (Clinical Severity Scale CSS)(6 months)
- Phenotyping (FSHD Comprehensive Clinical Evaluation Form CCEF)(6 months)
- Medical Research Council (MRC) Muscle Strength Grades(6 months)
- Magnetic resonance imaging(6 months)
- Dynamometer test of muscle strength(6 months)
- Intraclass correlation coefficient(6 months)