<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/NCT01662713</url>
  </required_header>
  <id_info>
    <org_study_id>2012P002430</org_study_id>
    <nct_id>NCT01662713</nct_id>
  </id_info>
  <brief_title>Optical Frequency Domain Imaging for Non-melanoma Skin Cancers</brief_title>
  <acronym>OFDI</acronym>
  <official_title>Optical Frequency Domain Imaging for Non-melanoma Skin Cancers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to find out if a non-invasive imaging device called&#xD;
      Optical Frequency Domain Imaging (OFDI) can help doctors to see the tissue and blood vessels&#xD;
      that are related to non-melanoma skin cancers. OFDI was designed to see microscopic details&#xD;
      of your skin without needing to use any invasive techniques such as surgery or biopsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Non-melanoma skin cancer (NMSC) is the most common cancer in the United States, with more&#xD;
      than 750,000 diagnosed patients treated every year. Its prevalence and incidence have&#xD;
      significantly increased over the past two decades and it has been estimated that 20% of all&#xD;
      Americans will develop this type of cancer during their lifetime (Neville et al., 2007).&#xD;
      Biopsy and surgical resection of NMSC can result in tissue mutilation and scaring. Therefore,&#xD;
      there is a need for new imaging technologies that can be used to non-invasively guide biopsy&#xD;
      and surgery.&#xD;
&#xD;
      Optical Frequency Domain Imaging (OFDI) is a second-generation imaging implementation of&#xD;
      optical coherence tomography (OCT) developed at the Wellman Center. OFDI provides&#xD;
      high-resolution three-dimensional imaging in tissue. It uses an interferometric&#xD;
      depth-sectioning technique and employs a near-infrared light source. Through analysis of&#xD;
      phase information in the recorded signal. OFDI can detect blood vessels within tissues and&#xD;
      tumors. Importantly, OFDI-based vascular imaging can be performed without the need for&#xD;
      exogenous contrast agents, making it relatively easy to deploy in clinical settings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Successful imaging of lesion</measure>
    <time_frame>After completion of imaging session</time_frame>
    <description>Images acquired of NMSC</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Non-Melanoma Skin Cancer (NMSC)</condition>
  <arm_group>
    <arm_group_label>NMSC Imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Optical Frequency Domain Imaging (OFDI) will be used to look at non melanoma skin cancer (NMSC) lesion(s).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OFDI</intervention_name>
    <description>Imaging of skin</description>
    <arm_group_label>NMSC Imaging</arm_group_label>
    <other_name>Optical Imaging</other_name>
    <other_name>Optical Coherence Tomography</other_name>
    <other_name>OCT</other_name>
    <other_name>Optical Frequency Domain Imaging</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female subjects with Fitzpatrick skin type I-VI&#xD;
&#xD;
          2. Subjects with ages between 18 and 80 years of age&#xD;
&#xD;
          3. Presence of at least one NMSC lesion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with active localized or systemic infections&#xD;
&#xD;
          2. Subjects participating in potentially confounding clinical studies of investigational&#xD;
             therapies, either drug or device.&#xD;
&#xD;
          3. Subjects taking any topical/systemic chemotherapy or immunosuppressants&#xD;
&#xD;
          4. Subjects who are pregnant and/or breastfeeding&#xD;
&#xD;
          5. Subjects with tape adhesive allergies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Benjamin Vakoc, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>March 13, 2023</last_update_submitted>
  <last_update_submitted_qc>March 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Benjamin Vakoc</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>skin cancer</keyword>
  <keyword>optical imaging</keyword>
  <keyword>optical coherence tomography</keyword>
  <keyword>optical frequency domain imaging</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/NCT01662713
org study id: 2012P002430
nct id: NCT01662713
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to find out if a non-invasive imaging device called
      Optical Frequency Domain Imaging (OFDI) can help doctors to see the tissue and blood vessels
      that are related to non-melanoma skin cancers. OFDI was designed to see microscopic details
      of your skin without needing to use any invasive techniques such as surgery or biopsy.
Non-melanoma skin cancer (NMSC) is the most common cancer in the United States, with more
      than 750,000 diagnosed patients treated every year. Its prevalence and incidence have
      significantly increased over the past two decades and it has been estimated that 20% of all
      Americans will develop this type of cancer during their lifetime (Neville et al., 2007).
      Biopsy and surgical resection of NMSC can result in tissue mutilation and scaring. Therefore,
      there is a need for new imaging technologies that can be used to non-invasively guide biopsy
      and surgery.

      Optical Frequency Domain Imaging (OFDI) is a second-generation imaging implementation of
      optical coherence tomography (OCT) developed at the Wellman Center. OFDI provides
      high-resolution three-dimensional imaging in tissue. It uses an interferometric
      depth-sectioning technique and employs a near-infrared light source. Through analysis of
      phase information in the recorded signal. OFDI can detect blood vessels within tissues and
      tumors. Importantly, OFDI-based vascular imaging can be performed without the need for
      exogenous contrast agents, making it relatively easy to deploy in clinical settings.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Successful imaging of lesion
time frame: After completion of imaging session
description: Images acquired of NMSC
arm group label: NMSC Imaging
arm group type: Experimental
description: Optical Frequency Domain Imaging (OFDI) will be used to look at non melanoma skin cancer (NMSC) lesion(s).
intervention type: Device
intervention name: OFDI
description: Imaging of skin
arm group label: NMSC Imaging
other name: Optical Imaging
other name: Optical Coherence Tomography
other name: OCT
other name: Optical Frequency Domain Imaging
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Benjamin Vakoc, PhD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Benjamin Vakoc
investigator title: Assistant Professor
mesh term: Skin Neoplasms