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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
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Schleswig-Holstein
-
Lübeck, Schleswig-Holstein, Tyskland, 23562
- Aktiv, inte rekryterande
- Clinic for Maxillofacial Surgery of the University Hospital Schleswig-Holstein
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Lübeck, Schleswig-Holstein, Tyskland, 23562
- Rekrytering
- University of Luebeck, Institute for Robotics
-
Kontakt:
- Floris Ernst, PhD
- Telefonnummer: +494515005208
- E-post: ernst@rob.uni-luebeck.de
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Huvudutredare:
- Floris Ernst, PhD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
|
Experimentell: 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
|
|
Experimentell: 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
|
|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Average accuracy of tissue thickness measurement method [mm]
Tidsram: up to 6 months
|
up to 6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
System dependency on skin color - required intensity
Tidsram: up to 6 months
|
Correlation between skin types (according to the Fitzpatrick scale) and the outcome (required laser intensity [mW])
|
up to 6 months
|
|
Long-term stability of measured features - accuracy
Tidsram: up to 8 months
|
Change in measurement accuracy [mm]
|
up to 8 months
|
|
Long-term stability of measured features - required intensity
Tidsram: up to 8 months
|
Change in required laser intensity [mW]
|
up to 8 months
|
|
Long-term stability of measured features - required exposure time
Tidsram: up to 8 months
|
Change in required exposure time [ms]
|
up to 8 months
|
|
System dependency on skin color - accuracy
Tidsram: up to 6 months
|
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
Tidsram: up to 6 months
|
Correlation between skin types (according to the Fitzpatrick scale) and the outcome (required exposure time [ms])
|
up to 6 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Floris Ernst, PhD, University of Luebeck
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- ROB-NIRMR-001
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