Cranial Soft Tissue
Conditions
Keywords
Patient, localisation, in cranial, radiation, therapy, thickness of
Brief summary
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.
Interventions
DEVICEMRI 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
DEVICELaser scan
A near-infrared laser scan of the subject's forehead is acquired
PROCEDUREDental cast creation
A dental cast made of PMMA (polymethyl methacrylate) of the subject's maxilla is created
Sponsors
Varian Medical Systems
University of Luebeck
Dr. Floris Ernst
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 *
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average accuracy of tissue thickness measurement method [mm] | up to 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long-term stability of measured features - accuracy | up to 8 months | Change in measurement accuracy \[mm\] |
| Long-term stability of measured features - required intensity | up to 8 months | Change in required laser intensity \[mW\] |
| System dependency on skin color - required intensity | up to 6 months | Correlation between skin types (according to the Fitzpatrick scale) and the outcome (required laser intensity \[mW\]) |
| System dependency on skin color - accuracy | up to 6 months | Correlation between skin types (according to the Fitzpatrick scale) and the outcome (accuracy of tissue thickness measurement \[mm\]) |
| System dependency on skin color - exposure time | up to 6 months | Correlation between skin types (according to the Fitzpatrick scale) and the outcome (required exposure time \[ms\]) |
| Long-term stability of measured features - required exposure time | up to 8 months | Change in required exposure time \[ms\] |
Countries
Germany
Contacts
Primary ContactFloris Ernst, PhD
Outcome results
None listed