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

20. august 2014 opdateret af: Dr. Floris Ernst

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

25

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Tyskland, 23562
        • Aktiv, ikke rekrutterende
        • Clinic for Maxillofacial Surgery of the University Hospital Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Tyskland, 23562
        • Rekruttering
        • University of Luebeck, Institute for Robotics
        • Kontakt:
        • Ledende efterforsker:
          • Floris Ernst, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Enhed: 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
Enhed: 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
Eksperimentel: Skin type III

Volunteers classified as skin type III according to the Fitzpatrick Scale

Procedures: dental cast creation, MRI scan, laser scan
Enhed: 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
Enhed: 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
Eksperimentel: Skin type IV

Volunteers classified as skin type IV according to the Fitzpatrick Scale

Procedures: dental cast creation, MRI scan, laser scan
Enhed: 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
Enhed: 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
Eksperimentel: 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
Enhed: 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
Enhed: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Average accuracy of tissue thickness measurement method [mm]
Tidsramme: up to 6 months
up to 6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
System dependency on skin color - required intensity
Tidsramme: 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
Tidsramme: up to 8 months
Change in measurement accuracy [mm]
up to 8 months
Long-term stability of measured features - required intensity
Tidsramme: up to 8 months
Change in required laser intensity [mW]
up to 8 months
Long-term stability of measured features - required exposure time
Tidsramme: up to 8 months
Change in required exposure time [ms]
up to 8 months
System dependency on skin color - accuracy
Tidsramme: 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
Tidsramme: up to 6 months
Correlation between skin types (according to the Fitzpatrick scale) and the outcome (required exposure time [ms])
up to 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Dr. Floris Ernst

Samarbejdspartnere

University of Luebeck
Varian Medical Systems

Efterforskere

  • Ledende efterforsker: Floris Ernst, PhD, University of Luebeck

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2013

Primær færdiggørelse (Forventet)

1. december 2014

Studieafslutning (Forventet)

1. februar 2015

Datoer for studieregistrering

Først indsendt

12. august 2013

Først indsendt, der opfyldte QC-kriterier

15. august 2013

Først opslået (Skøn)

16. august 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. august 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. august 2014

Sidst verificeret

1. august 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • ROB-NIRMR-001

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Cranial Soft Tissue

Kliniske forsøg med MRI scan

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