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Validation of a Method to Measure Soft Tissue Thickness Using Near Infrared Laser Light

NCT01924338 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2014-08-21

No results posted yet for this study

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.

Conditions

  • Cranial Soft Tissue

Interventions

DEVICE

MRI 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

DEVICE

Laser scan

A near-infrared laser scan of the subject's forehead is acquired

PROCEDURE

Dental cast creation

A dental cast made of PMMA (polymethyl methacrylate) of the subject's maxilla is created

Sponsors & Collaborators

  • Varian Medical Systems

    collaborator INDUSTRY

  • University of Luebeck

    collaborator OTHER

  • Dr. Floris Ernst

    lead OTHER

Principal Investigators

  • Floris Ernst, PhD · University of Luebeck

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-12-31
Completion
2015-02-28

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01924338 on ClinicalTrials.gov