<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01680562</url>
  </required_header>
  <id_info>
    <org_study_id>1126/2009</org_study_id>
    <secondary_id>201880</secondary_id>
    <nct_id>NCT01680562</nct_id>
  </id_info>
  <brief_title>In-vivo Optical Coherence Tomography Imaging in Dermatooncology</brief_title>
  <official_title>Improving Diagnosis of Skin Cancer Patients Via Optical Coherence Tomography and Teledermatology- A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In vivo differentiation of benign and malignant skin lesions is a fundamental issue in&#xD;
      clinical dermatology. Malignant skin diseases are known to be accompanied by structural&#xD;
      alterations. Conventional excisional biopsies and further histopathology are regarded as the&#xD;
      reference standard for investigating these pathologies. Biopsies are invasive procedures and&#xD;
      additionally may cause side effects. Therefore, research efforts are focused on the&#xD;
      development of diagnostic techniques capable of providing in vivo information on the skin's&#xD;
      structure. Optical coherence tomography (OCT) is a technical application, which allows the&#xD;
      identification of microscopic patterns indicative for benign and malignant skin lesions. OCT&#xD;
      is a promising noninvasive imaging technique for the micromorphology of the skin. So far,&#xD;
      it's clinical application, as an additional diagnostic tool for malignant skin lesions has&#xD;
      been studied in a limited extend. To evaluate the clinical usefulness of OCT, we conducted a&#xD;
      prospective pilot study at the Department of Dermatology, Medical University of Vienna. The&#xD;
      study is in cooperation with the Center of Biomedical Engineering and Physics at the Medical&#xD;
      University of Vienna.&#xD;
&#xD;
      A total of 70 malignant skin lesions was evaluated during this prospective pilot study.&#xD;
      Diagnoses based on OCT imaging as an additional diagnostic tool, were compared to those based&#xD;
      on the clinical standard pathway at the Department of Dermatology, Medical University of&#xD;
      Vienna. For the purpose of this study, the histopathological diagnosis was used as the&#xD;
      reference diagnostic standard.&#xD;
&#xD;
      The major aims of this study is the investigation of the ability of ultrahigh resolution OCT&#xD;
      to identify fine morphological characteristics associated with basal cell carcinoma, actinic&#xD;
      keratosis, superficial squamous cell carcinoma, seborrheic keratosis, melanocytic nevi and&#xD;
      melanoma.&#xD;
&#xD;
        -  To correlate the morphologic features identified with ultrahigh resolution OCT with&#xD;
           routine histopathology&#xD;
&#xD;
        -  To investigate the clinical feasibility of ultrahigh resolution and spectroscopic OCT&#xD;
           technology&#xD;
&#xD;
        -  To assess the effectiveness of ultrahigh resolution and spectroscopic OCT imaging to&#xD;
           diagnose various melanocytic and non-melanocytic skin tumors&#xD;
&#xD;
        -  To compare the diagnostic capabilities of ultrahigh resolution OCT with standard&#xD;
           non-invasive diagnostic procedures such as epiluminescence microscopy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Optical coherence tomography (OCT) is a technical application, which allows the&#xD;
      identification of microscopic patterns indicative for benign and malignant skin lesions. It&#xD;
      is a promising non-invasive imaging technique for the micromorphology of the skin. OCT&#xD;
      provides in vivo cross sectional tomographic images of tissue in situ and real-time with&#xD;
      micrometer resolution. It works analogously to ultrasound; the reflection of infrared light,&#xD;
      instead of acoustical waves, from the skin is measured and the signal strength is imaged as a&#xD;
      function of position. Depending on the scattering properties of tissue and some accepted loss&#xD;
      in resolution, a penetration depth of up to 2 mm can be achieved. The image data are&#xD;
      displayed by assigning color or gray scales to each reflection, according to the measured&#xD;
      signal strength. The OCT probe is applied directly after application of ultrasound gel to the&#xD;
      skin. Acquisition time for an OCT image is approximately 3 seconds.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2010</start_date>
  <completion_date type="Anticipated">December 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Optical coherence tomography (OCT) imaging quality of skin tumor formations versus corresponding histopathology.</measure>
    <time_frame>two years</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">37</enrollment>
  <condition>Non-melanocytic Skin Tumors</condition>
  <condition>Melanocytic Skin Tumors</condition>
  <arm_group>
    <arm_group_label>skin cancer</arm_group_label>
    <description>Skin cancer patients with scheduled tumor excision and subsequent histopathological analysis of the tumor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>in-vivo skin tumor imaging via optical coherence tomography</intervention_name>
    <description>optical coherence tomography imaging of skin lesion; digital dermoscopy imaging of skin lesion</description>
    <arm_group_label>skin cancer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Skin tumor patients with subsequent excision and histopathological analysis at the&#xD;
        department of dermatology, Medical University of Vienna&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  seborrhoeic warts&#xD;
&#xD;
          -  nevi&#xD;
&#xD;
          -  dermatofibroma&#xD;
&#xD;
          -  basal cell carcinoma&#xD;
&#xD;
          -  actinic keratosis&#xD;
&#xD;
          -  squamous cell carcinoma&#xD;
&#xD;
          -  Bowen's disease&#xD;
&#xD;
          -  Merkel cell carcinoma&#xD;
&#xD;
          -  malignant melanoma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  employers of the Medical University of Vienna&#xD;
&#xD;
          -  patients during compulsory military service&#xD;
&#xD;
          -  patients with an appointed guardian&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Binder, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Vienna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Dermatology, Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>September 4, 2012</last_update_submitted>
  <last_update_submitted_qc>September 4, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 7, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Jessika Weingast, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>in-vivo skin imaging</keyword>
  <keyword>non-invasive non-melanoma skin cancer diagnostics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Skin Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01680562
org study id: 1126/2009
secondary id: 201880
nct id: NCT01680562
lead sponsor: 
has dmc: No
In vivo differentiation of benign and malignant skin lesions is a fundamental issue in
      clinical dermatology. Malignant skin diseases are known to be accompanied by structural
      alterations. Conventional excisional biopsies and further histopathology are regarded as the
      reference standard for investigating these pathologies. Biopsies are invasive procedures and
      additionally may cause side effects. Therefore, research efforts are focused on the
      development of diagnostic techniques capable of providing in vivo information on the skin's
      structure. Optical coherence tomography (OCT) is a technical application, which allows the
      identification of microscopic patterns indicative for benign and malignant skin lesions. OCT
      is a promising noninvasive imaging technique for the micromorphology of the skin. So far,
      it's clinical application, as an additional diagnostic tool for malignant skin lesions has
      been studied in a limited extend. To evaluate the clinical usefulness of OCT, we conducted a
      prospective pilot study at the Department of Dermatology, Medical University of Vienna. The
      study is in cooperation with the Center of Biomedical Engineering and Physics at the Medical
      University of Vienna.

      A total of 70 malignant skin lesions was evaluated during this prospective pilot study.
      Diagnoses based on OCT imaging as an additional diagnostic tool, were compared to those based
      on the clinical standard pathway at the Department of Dermatology, Medical University of
      Vienna. For the purpose of this study, the histopathological diagnosis was used as the
      reference diagnostic standard.

      The major aims of this study is the investigation of the ability of ultrahigh resolution OCT
      to identify fine morphological characteristics associated with basal cell carcinoma, actinic
      keratosis, superficial squamous cell carcinoma, seborrheic keratosis, melanocytic nevi and
      melanoma.

        -  To correlate the morphologic features identified with ultrahigh resolution OCT with
           routine histopathology

        -  To investigate the clinical feasibility of ultrahigh resolution and spectroscopic OCT
           technology

        -  To assess the effectiveness of ultrahigh resolution and spectroscopic OCT imaging to
           diagnose various melanocytic and non-melanocytic skin tumors

        -  To compare the diagnostic capabilities of ultrahigh resolution OCT with standard
           non-invasive diagnostic procedures such as epiluminescence microscopy
Optical coherence tomography (OCT) is a technical application, which allows the
      identification of microscopic patterns indicative for benign and malignant skin lesions. It
      is a promising non-invasive imaging technique for the micromorphology of the skin. OCT
      provides in vivo cross sectional tomographic images of tissue in situ and real-time with
      micrometer resolution. It works analogously to ultrasound; the reflection of infrared light,
      instead of acoustical waves, from the skin is measured and the signal strength is imaged as a
      function of position. Depending on the scattering properties of tissue and some accepted loss
      in resolution, a penetration depth of up to 2 mm can be achieved. The image data are
      displayed by assigning color or gray scales to each reflection, according to the measured
      signal strength. The OCT probe is applied directly after application of ultrasound gel to the
      skin. Acquisition time for an OCT image is approximately 3 seconds.
observational model: Case-Only
time perspective: Prospective
measure: Optical coherence tomography (OCT) imaging quality of skin tumor formations versus corresponding histopathology.
time frame: two years
arm group label: skin cancer
description: Skin cancer patients with scheduled tumor excision and subsequent histopathological analysis of the tumor.
intervention type: Other
intervention name: in-vivo skin tumor imaging via optical coherence tomography
description: optical coherence tomography imaging of skin lesion; digital dermoscopy imaging of skin lesion
arm group label: skin cancer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Binder, MD
role: Principal Investigator
affiliation: Medical University of Vienna
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Jessika Weingast, MD
investigator title: Principal Investigator
mesh term: Skin Neoplasms