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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

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.


Condition or disease Intervention/treatment Phase
Cranial Soft Tissue Device: MRI scan Device: Laser scan Procedure: Dental cast creation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Validierung Der Bestimmung Der Gewebedicke Mit Hilfe Von Licht im Infrarotbereich
Study Start Date : September 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : February 2015

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Average accuracy of tissue thickness measurement method [mm] [ Time Frame: up to 6 months ]

Secondary Outcome Measures :
  1. 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])

  2. Long-term stability of measured features - accuracy [ Time Frame: up to 8 months ]
    Change in measurement accuracy [mm]

  3. Long-term stability of measured features - required intensity [ Time Frame: up to 8 months ]
    Change in required laser intensity [mW]

  4. Long-term stability of measured features - required exposure time [ Time Frame: up to 8 months ]
    Change in required exposure time [ms]

  5. 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])

  6. 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])



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01924338


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

Locations
Germany
Clinic for Maxillofacial Surgery of the University Hospital Schleswig-Holstein Active, not recruiting
Lübeck, Schleswig-Holstein, Germany, 23562
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         
Sponsors and Collaborators
Dr. Floris Ernst
Varian Medical Systems
University of Luebeck
Investigators
Principal Investigator: Floris Ernst, PhD University of Luebeck

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
First Posted: August 16, 2013    Key Record Dates
Last Update Posted: August 21, 2014
Last Verified: August 2014

Keywords provided by Dr. Floris Ernst, University of Luebeck:
Patient
localisation
in cranial
radiation
therapy
thickness of