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

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ClinicalTrials.gov Identifier: NCT01924338
Recruitment Status : Unknown
Verified August 2014 by Dr. Floris Ernst, University of Luebeck.
Recruitment status was:  Recruiting
First Posted : August 16, 2013
Last Update Posted : August 21, 2014
Sponsor:
Collaborators:
Varian Medical Systems
University of Luebeck
Information provided by (Responsible Party):
Dr. Floris Ernst, University of Luebeck

August 12, 2013
August 16, 2013
August 21, 2014
September 2013
December 2014   (Final data collection date for primary outcome measure)
Average accuracy of tissue thickness measurement method [mm] [ Time Frame: up to 6 months ]
Same as current
Complete list of historical versions of study NCT01924338 on ClinicalTrials.gov Archive Site
  • System dependency on skin color - required intensity [ Time Frame: up to 6 months ]
    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 ]
    Change in measurement accuracy [mm]
  • Long-term stability of measured features - required intensity [ Time Frame: up to 8 months ]
    Change in required laser intensity [mW]
  • Long-term stability of measured features - required exposure time [ Time Frame: up to 8 months ]
    Change in required exposure time [ms]
  • System dependency on skin color - accuracy [ Time Frame: 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 [ Time Frame: up to 6 months ]
    Correlation between skin types (according to the Fitzpatrick scale) and the outcome (required exposure time [ms])
  • System dependency on skin color [ Time Frame: up to 6 months ]
    Correlation between skin types (according to the Fitzpatrick scale) and the outcomes (tissue thickness [mm], laser intensity [mW], exposure time [ms])
  • Long-term stability of measured features [ Time Frame: up to 8 months ]
    Change in measurement accuracy [mm], required laser intensity [mW] and exposure time [ms]
Not Provided
Not Provided
 
Validation of a Method to Measure Soft Tissue Thickness Using Near Infrared Laser Light
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.

Not Provided
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Cranial Soft Tissue
  • 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 I and II

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

    Procedures: dental cast creation, MRI scan, laser scan

    Interventions:
    • Device: MRI scan
    • Device: Laser scan
    • Procedure: Dental cast creation
  • Experimental: Skin type III

    Volunteers classified as skin type III according to the Fitzpatrick Scale

    Procedures: dental cast creation, MRI scan, laser scan

    Interventions:
    • Device: MRI scan
    • Device: Laser scan
    • Procedure: Dental cast creation
  • Experimental: Skin type IV

    Volunteers classified as skin type IV according to the Fitzpatrick Scale

    Procedures: dental cast creation, MRI scan, laser scan

    Interventions:
    • Device: MRI scan
    • Device: Laser scan
    • Procedure: Dental cast creation
  • 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

    Interventions:
    • Device: MRI scan
    • Device: Laser scan
    • Procedure: Dental cast creation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
25
Same as current
February 2015
December 2014   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01924338
ROB-NIRMR-001
No
Not Provided
Not Provided
Dr. Floris Ernst, University of Luebeck
Dr. Floris Ernst
  • Varian Medical Systems
  • University of Luebeck
Principal Investigator: Floris Ernst, PhD University of Luebeck
University of Luebeck
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP