Clinical trial NCT01924338: Validation of a Method to Measure Soft Tissue Thickness Using Near Infrared Laser Light
Official title: Validierung Der Bestimmung Der Gewebedicke Mit Hilfe Von Licht im Infrarotbereich
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cranial Soft Tissue
Keywords: Patient
localisation
in cranial
radiation
therapy
thickness of
Lead sponsor: University of Luebeck
Sponsor class: OTHER
Collaborators: name: Varian Medical Systems
name: University of Luebeck
First posted: 2013-08-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Average accuracy of tissue thickness measurement method [mm]
timeFrame: up to 6 months
Secondary outcomes:
measure: System dependency on skin color - required intensity
timeFrame: up to 6 months
measure: Long-term stability of measured features - accuracy
timeFrame: up to 8 months
measure: Long-term stability of measured features - required intensity
timeFrame: up to 8 months
measure: Long-term stability of measured features - required exposure time
timeFrame: up to 8 months
measure: System dependency on skin color - accuracy
timeFrame: up to 6 months
measure: System dependency on skin color - exposure time
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: Clinic for Maxillofacial Surgery of the University Hospital Schleswig-Holstein
state: Schleswig-Holstein
city: Lübeck
country: Germany
facility: University of Luebeck, Institute for Robotics
state: Schleswig-Holstein
Study officials:
affiliation: University of Luebeck
name: Floris Ernst, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.