Cranial Soft Tissue Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 25 |
| Est. completion date | February 2015 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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) |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Germany | Clinic for Maxillofacial Surgery of the University Hospital Schleswig-Holstein | Lübeck | Schleswig-Holstein |
| Germany | University of Luebeck, Institute for Robotics | Lübeck | Schleswig-Holstein |
| Lead Sponsor | Collaborator |
|---|---|
| Dr. Floris Ernst | University of Luebeck, Varian Medical Systems |
Germany,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Average accuracy of tissue thickness measurement method [mm] | up to 6 months | No | |
| Secondary | 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 | No |
| Secondary | Long-term stability of measured features - accuracy | Change in measurement accuracy [mm] | up to 8 months | No |
| Secondary | Long-term stability of measured features - required intensity | Change in required laser intensity [mW] | up to 8 months | No |
| Secondary | Long-term stability of measured features - required exposure time | Change in required exposure time [ms] | up to 8 months | No |
| Secondary | 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 | No |
| Secondary | 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 | No |