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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Luebeck
Sponsor:
Collaborators:
Varian Medical Systems
Graduate School for Computing in Medicine and Life Sciences of the University of Lübeck
Information provided by (Responsible Party):
Dr. Floris Ernst, University of Luebeck
ClinicalTrials.gov Identifier:
NCT01924338
First received: August 12, 2013
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Cranial Soft Tissue
Device: MRI scan
Device: Laser scan
Procedure: Dental cast creation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Validierung Der Bestimmung Der Gewebedicke Mit Hilfe Von Licht im Infrarotbereich

Resource links provided by NLM:


Further study details as provided by University of Luebeck:

Primary Outcome Measures:
  • Average accuracy of tissue thickness measurement method [mm] [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • System dependency on skin color - required intensity [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    Correlation between skin types (according to the Fitzpatrick scale) and the outcome (required laser intensity [mW])

  • Long-term stability of measured features - accuracy [ Time Frame: up to 8 months ] [ Designated as safety issue: No ]
    Change in measurement accuracy [mm]

  • Long-term stability of measured features - required intensity [ Time Frame: up to 8 months ] [ Designated as safety issue: No ]
    Change in required laser intensity [mW]

  • Long-term stability of measured features - required exposure time [ Time Frame: up to 8 months ] [ Designated as safety issue: No ]
    Change in required exposure time [ms]

  • System dependency on skin color - accuracy [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    Correlation between skin types (according to the Fitzpatrick scale) and the outcome (required exposure time [ms])


Estimated Enrollment: 25
Study Start Date: September 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Skin types I and II

Volunteers classified as skin types I and II according to the Fitzpatrick Scale

Procedures: dental cast creation, MRI scan, laser scan

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
Experimental: Skin type III

Volunteers classified as skin type III according to the Fitzpatrick Scale

Procedures: dental cast creation, MRI scan, laser scan

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
Experimental: Skin type IV

Volunteers classified as skin type IV according to the Fitzpatrick Scale

Procedures: dental cast creation, MRI scan, laser scan

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
Experimental: Skin types V and VI

Volunteers classified as skin types V and VI according to the Fitzpatrick Scale

Procedures: dental cast creation, MRI scan, laser scan

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01924338

Contacts
Contact: Floris Ernst, PhD +494515005208 ernst@rob.uni-luebeck.de

Locations
Germany
University of Luebeck, Institute for Robotics Recruiting
Lübeck, Schleswig-Holstein, Germany, 23562
Contact: Floris Ernst, PhD    +494515005208    ernst@rob.uni-luebeck.de   
Principal Investigator: Floris Ernst, PhD         
Clinic for Maxillofacial Surgery of the University Hospital Schleswig-Holstein Active, not recruiting
Lübeck, Schleswig-Holstein, Germany, 23562
Sponsors and Collaborators
Dr. Floris Ernst
Varian Medical Systems
Graduate School for Computing in Medicine and Life Sciences of the University of Lübeck
Investigators
Principal Investigator: Floris Ernst, PhD University of Luebeck
  More Information

Additional Information:
Publications:
Responsible Party: Dr. Floris Ernst, Senior Research Associate, University of Luebeck
ClinicalTrials.gov Identifier: NCT01924338     History of Changes
Other Study ID Numbers: ROB-NIRMR-001
Study First Received: August 12, 2013
Last Updated: August 20, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by University of Luebeck:
Patient
localisation
in cranial
radiation
therapy
thickness of

ClinicalTrials.gov processed this record on August 20, 2014