Validation of a Method to Measure Soft Tissue Thickness Using Near Infrared Laser Light
Validierung Der Bestimmung Der Gewebedicke Mit Hilfe Von Licht im Infrarotbereich
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.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Schleswig-Holstein
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Lübeck、Schleswig-Holstein、德国、23562
- 主动，不招人
- Clinic for Maxillofacial Surgery of the University Hospital Schleswig-Holstein
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Lübeck、Schleswig-Holstein、德国、23562
- 招聘中
- University of Luebeck, Institute for Robotics
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接触：
- Floris Ernst, PhD
- 电话号码：+494515005208
- 邮箱：ernst@rob.uni-luebeck.de
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首席研究员：
- Floris Ernst, PhD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Skin types I and II
Volunteers classified as skin types I and II according to the Fitzpatrick Scale Procedures: dental cast creation, MRI scan, laser scan |
Acquisition of a high-resolution MRI scan (0.15 x 0.15 x 1.0 mm³) aligned with the AC-PC (anterior commissure-posterior commissure) line
A near-infrared laser scan of the subject's forehead is acquired
A dental cast made of PMMA (polymethyl methacrylate) of the subject's maxilla is created
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实验性的：Skin type III
Volunteers classified as skin type III according to the Fitzpatrick Scale Procedures: dental cast creation, MRI scan, laser scan |
Acquisition of a high-resolution MRI scan (0.15 x 0.15 x 1.0 mm³) aligned with the AC-PC (anterior commissure-posterior commissure) line
A near-infrared laser scan of the subject's forehead is acquired
A dental cast made of PMMA (polymethyl methacrylate) of the subject's maxilla is created
|
|
实验性的：Skin type IV
Volunteers classified as skin type IV according to the Fitzpatrick Scale Procedures: dental cast creation, MRI scan, laser scan |
Acquisition of a high-resolution MRI scan (0.15 x 0.15 x 1.0 mm³) aligned with the AC-PC (anterior commissure-posterior commissure) line
A near-infrared laser scan of the subject's forehead is acquired
A dental cast made of PMMA (polymethyl methacrylate) of the subject's maxilla is created
|
|
实验性的：Skin types V and VI
Volunteers classified as skin types V and VI according to the Fitzpatrick Scale Procedures: dental cast creation, MRI scan, laser scan |
Acquisition of a high-resolution MRI scan (0.15 x 0.15 x 1.0 mm³) aligned with the AC-PC (anterior commissure-posterior commissure) line
A near-infrared laser scan of the subject's forehead is acquired
A dental cast made of PMMA (polymethyl methacrylate) of the subject's maxilla is created
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Average accuracy of tissue thickness measurement method [mm]
大体时间：up to 6 months
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up to 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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System dependency on skin color - required intensity
大体时间：up to 6 months
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Correlation between skin types (according to the Fitzpatrick scale) and the outcome (required laser intensity [mW])
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up to 6 months
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Long-term stability of measured features - accuracy
大体时间：up to 8 months
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Change in measurement accuracy [mm]
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up to 8 months
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Long-term stability of measured features - required intensity
大体时间：up to 8 months
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Change in required laser intensity [mW]
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up to 8 months
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Long-term stability of measured features - required exposure time
大体时间：up to 8 months
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Change in required exposure time [ms]
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up to 8 months
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System dependency on skin color - accuracy
大体时间：up to 6 months
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Correlation between skin types (according to the Fitzpatrick scale) and the outcome (accuracy of tissue thickness measurement [mm])
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up to 6 months
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System dependency on skin color - exposure time
大体时间：up to 6 months
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Correlation between skin types (according to the Fitzpatrick scale) and the outcome (required exposure time [ms])
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up to 6 months
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合作者和调查者
调查人员
- 首席研究员：Floris Ernst, PhD、University of Luebeck
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- ROB-NIRMR-001
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