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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Schleswig-Holstein
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Lübeck, Schleswig-Holstein, Duitsland, 23562
- Actief, niet wervend
- Clinic for Maxillofacial Surgery of the University Hospital Schleswig-Holstein
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Lübeck, Schleswig-Holstein, Duitsland, 23562
- Werving
- University of Luebeck, Institute for Robotics
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Contact:
- Floris Ernst, PhD
- Telefoonnummer: +494515005208
- E-mail: ernst@rob.uni-luebeck.de
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Hoofdonderzoeker:
- Floris Ernst, PhD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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 |
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
A near-infrared laser scan of the subject's forehead is acquired
A dental cast made of PMMA (polymethyl methacrylate) of the subject's maxilla is created
|
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Experimenteel: Skin type III
Volunteers classified as skin type III according to the Fitzpatrick Scale Procedures: dental cast creation, MRI scan, laser 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
A near-infrared laser scan of the subject's forehead is acquired
A dental cast made of PMMA (polymethyl methacrylate) of the subject's maxilla is created
|
|
Experimenteel: Skin type IV
Volunteers classified as skin type IV according to the Fitzpatrick Scale Procedures: dental cast creation, MRI scan, laser 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
A near-infrared laser scan of the subject's forehead is acquired
A dental cast made of PMMA (polymethyl methacrylate) of the subject's maxilla is created
|
|
Experimenteel: 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 |
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
A near-infrared laser scan of the subject's forehead is acquired
A dental cast made of PMMA (polymethyl methacrylate) of the subject's maxilla is created
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Average accuracy of tissue thickness measurement method [mm]
Tijdsspanne: up to 6 months
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up to 6 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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System dependency on skin color - required intensity
Tijdsspanne: up to 6 months
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Correlation between skin types (according to the Fitzpatrick scale) and the outcome (required laser intensity [mW])
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up to 6 months
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Long-term stability of measured features - accuracy
Tijdsspanne: up to 8 months
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Change in measurement accuracy [mm]
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up to 8 months
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Long-term stability of measured features - required intensity
Tijdsspanne: up to 8 months
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Change in required laser intensity [mW]
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up to 8 months
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Long-term stability of measured features - required exposure time
Tijdsspanne: up to 8 months
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Change in required exposure time [ms]
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up to 8 months
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System dependency on skin color - accuracy
Tijdsspanne: up to 6 months
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Correlation between skin types (according to the Fitzpatrick scale) and the outcome (accuracy of tissue thickness measurement [mm])
|
up to 6 months
|
|
System dependency on skin color - exposure time
Tijdsspanne: up to 6 months
|
Correlation between skin types (according to the Fitzpatrick scale) and the outcome (required exposure time [ms])
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up to 6 months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Floris Ernst, PhD, University of Luebeck
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- ROB-NIRMR-001
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