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| Name | Class |
|---|---|
| Varian Medical Systems | INDUSTRY |
| University of Luebeck | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Skin types I and II | Experimental | Volunteers classified as skin types I and II according to the Fitzpatrick Scale Procedures: dental cast creation, MRI scan, laser scan |
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| Skin type III | Experimental | Volunteers classified as skin type III according to the Fitzpatrick Scale Procedures: dental cast creation, MRI scan, laser scan |
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| Skin type IV | Experimental | Volunteers classified as skin type IV according to the Fitzpatrick Scale Procedures: dental cast creation, MRI scan, laser scan |
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| Skin types V and VI | Experimental | Volunteers classified as skin types V and VI according to the Fitzpatrick Scale Procedures: dental cast creation, MRI scan, laser scan |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI scan | Device | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average accuracy of tissue thickness measurement method [mm] | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| System dependency on skin color - required intensity | Correlation between skin types (according to the Fitzpatrick scale) and the outcome (required laser intensity [mW]) | up to 6 months |
| Long-term stability of measured features - accuracy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Floris Ernst, PhD | Contact | +494515005208 | ernst@rob.uni-luebeck.de |
| Name | Affiliation | Role |
|---|---|---|
| Floris Ernst, PhD | University of Luebeck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic for Maxillofacial Surgery of the University Hospital Schleswig-Holstein | Active, not recruiting | Lübeck | Schleswig-Holstein | 23562 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23847741 | Background | Wissel T, Bruder R, Schweikard A, Ernst F. Estimating soft tissue thickness from light-tissue interactions--a simulation study. Biomed Opt Express. 2013 Jun 14;4(7):1176-87. doi: 10.1364/BOE.4.001176. Print 2013 Jul 1. |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Laser scan | Device | A near-infrared laser scan of the subject's forehead is acquired |
|
| Dental cast creation | Procedure | A dental cast made of PMMA (polymethyl methacrylate) of the subject's maxilla is created |
|
Change in measurement accuracy [mm]
| up to 8 months |
| Long-term stability of measured features - required intensity | Change in required laser intensity [mW] | up to 8 months |
| Long-term stability of measured features - required exposure time | Change in required exposure time [ms] | up to 8 months |
| System dependency on skin color - accuracy | Correlation between skin types (according to the Fitzpatrick scale) and the outcome (accuracy of tissue thickness measurement [mm]) | up to 6 months |
| System dependency on skin color - exposure time | Correlation between skin types (according to the Fitzpatrick scale) and the outcome (required exposure time [ms]) | up to 6 months |
| University of Luebeck, Institute for Robotics | Recruiting | Lübeck | Schleswig-Holstein | 23562 | Germany |
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