Non-invasive Molecular Imaging to Determine Hemoglobin and Collagen Levels in Muscles Before and After Exercise, and Over Time
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Muscular collagen content
研究概览
简要总结
This study aims to determine hemoglobin and collagen levels in muscles before and after exercise, and over time, using Multispectral Optoacoustic Tomography (MSOT). During MSOT, a transducer is placed on the skin similar to a conventional sonography and instead of sound, energy is supplied to the tissue by means of light flashes. This leads to a constant change of minimal expansions and contractions (thermoelastic expansion) of individual tissue constituents or molecules. The resulting sound waves can then be detected by the same examination unit.
详细描述
Duchenne muscular dystrophy (DMD) is one of the most common progressive childhood muscle diseases with an incidence of 1 in 3500 male newborns and is associated primarily with decreased life expectancy. Pathogenetically, there is a deficiency of dystrophin, a structural protein of the sarcolemma, which is caused by mutations (usually deletions) of the dystrophin gene (Xp21.3-p21.2). The result of dystrophin deficiency is a necrosis of muscle cells that are replaced by connective tissue and adipose tissue. Clinical scores (6-minute walk test, 6MWT) and MRI studies to characterize the degenerative changes of skeletal muscle in the early stages are available for the quantitative assessment of the disease progression as well as therapy effects, the significance of which is controversially discussed. However, the highly sensitive assessment of gene therapy effects will become increasingly important in the future. Sensitive, non-invasive methods for the detection of early muscle degeneration and muscle function in the course are of great clinical and scientific importance.
MSOT has already been demonstrated to be a potential monitoring tool in different diseases. However, it has not yet been investigated to what extent 1) previous physical activity 2) different measuring ranges at the muscle, 3) longitudinal measurements and 4) intra- and interoperative variability influences the measured results. In particular, molecular changes immediately after the 6-MWT are relevant for studies in patients with DMD.
In this first pilot study, the investigators want to investigate in healthy adults, whether increased exercise changes the hemoglobin values, whether the collagen content remains constant and whether repeated measurements at different muscle positions by different investigators provide consistent results over time. This information is indispensable for future studies of children with muscular diseases in order to be able to make statements about disease progression or even therapy response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
排除标准
- •any reference to a myopathy
- •pregnancy
- •tattoo in the scanning region
结局指标
主要结局
Muscular collagen content
时间窗: one time point ( 2 measurements on day 1)
Quantitative collagen signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in muscles of healthy volunteers compared before and after 6-MWT.
Muscular myo-/hemoglobin content
时间窗: one time point ( 2 measurements on day 1)
Quantitative myo-/hemoglobin signal derived by transcutaneous Multispectral Optoacoustic Tomography (MSOT) in muscles of healthy volunteers compared before and after 6-MWT.
次要结局
- Muscular oxygenated and deoxygenated myo-/hemoglobin content(multiple time points ( 2 measurements on day 1 and 2 measurements on day 15))
- Intraindividual collagen content(multiple time points ( 2 measurements on day 1 and 2 measurements on day 15))
- Muscular collagen content in men and women(multiple time points ( 2 measurements on day 1 and 2 measurements on day 15))
- Muscular myo-/hemoglobin content in men and women(multiple time points ( 2 measurements on day 1 and 2 measurements on day 15))
- Muscular oxygenated and deoxygenated myo-/hemoglobin content in men and women(multiple time points ( 2 measurements on day 1 and 2 measurements on day 15))
- Correlation of collagen signal with the 6-MWT(multiple time points ( 2 measurements on day 1 and 2 measurements on day 15))
- Correlation of myo-/hemoglobin signal with the 6-MWT(multiple time points ( 2 measurements on day 1 and 2 measurements on day 15))
- Correlation of oxygenated and deoxygenated myo-/hemoglobin signal with the 6-MWT(multiple time points ( 2 measurements on day 1 and 2 measurements on day 15))
- Interrater reliability of collagen content(multiple time points ( 2 measurements on day 1 and 2 measurements on day 15))
- Interrater reliability of myo-/hemoglobin content(multiple time points ( 2 measurements on day 1 and 2 measurements on day 15))
- Intraindividual myo-/hemoglobin content(multiple time points ( 2 measurements on day 1 and 2 measurements on day 15))
- Intraindividual oxygenated and deoxygenated myo-/hemoglobin content(multiple time points ( 2 measurements on day 1 and 2 measurements on day 15))
- Interrater reliability of oxygenated and deoxygenated myo-/hemoglobin content(multiple time points ( 2 measurements on day 1 and 2 measurements on day 15))
- Interreader reliability of collagen content(multiple time points ( 2 measurements on day 1 and 2 measurements on day 15))
- Interreader reliability of myo-/hemoglobin content(multiple time points ( 2 measurements on day 1 and 2 measurements on day 15))
- Interreader reliability of oxygenated and deoxygenated myo-/hemoglobin content(multiple time points ( 2 measurements on day 1 and 2 measurements on day 15))
- Muscular collagen content over time period(multiple time points ( 2 measurements on day 1 and 2 measurements on day 15))
- Muscular myo-/hemoglobin content over time period(multiple time points ( 2 measurements on day 1 and 2 measurements on day 15))