Validierung Der Bestimmung Der Gewebedicke Mit Hilfe Von Licht im Infrarotbereich
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Average accuracy of tissue thickness measurement method [mm]
研究概览
简要总结
The study is intended to verify a newly developed method to measure the thickness of cranial soft tissue. In the study, a high-resolution MRI scan is used as ground truth for a laser scan of the forehead. The laser scan is acquired point by point with a prototype scanning unit developed at the University of Luebeck's Institute for Robotics.
The measured tissue thickness using the near-infrared scanning approach is validated against the ground truth obtained by the MRI scan. The average accuracy of the reconstruction method is then computed over all subjects from the individual study arms.
The required laser intensity and exposure time as well as the achieved measurement accuracy is evaluated with respect to the different skin types of the test subjects. Correlation between these features and the skin type according to the Fitzpatrick scale will be computed.
For 1/3 of the subjects, the laser and MRI scans are repeated after 2 and 8 weeks. The results of the scans are compared and time dependency is analysed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •male and female adults
- •variations in skin type (at least 10 subjects with skin types I & II, at least 2 subjects with skin type III, at least 3 subjects with skin type IV, at least 3 subjects with skin types V & VI)
- •optional: availability of high-resolution CT or CBCT (cone-beam CT) scan of the forehead
排除标准
- •allergies or intolerances against ABS (acrylonitrile butadiene styrene), PMMA (polymethyl methacrylate) or alginate
- •elevated light sensitivity of the skin
- •exclusion criteria for MRI (claustrophobia, motoric disorders, tattoos, body piercings, metallic implants in the skull, epilepsy, cardiac pacemakers)
结局指标
主要结局
Average accuracy of tissue thickness measurement method [mm]
时间窗: up to 6 months
次要结局
- Long-term stability of measured features - accuracy(up to 8 months)
- Long-term stability of measured features - required exposure time(up to 8 months)
- System dependency on skin color - exposure time(up to 6 months)
- Long-term stability of measured features - required intensity(up to 8 months)
- System dependency on skin color - accuracy(up to 6 months)
- System dependency on skin color - required intensity(up to 6 months)
研究者
Dr. Floris Ernst
Senior Research Associate
University of Luebeck