<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/NCT01673971</url>
  </required_header>
  <id_info>
    <org_study_id>AAAJ1201</org_study_id>
    <nct_id>NCT01673971</nct_id>
  </id_info>
  <brief_title>Optical Tomographic Imaging of Infantile Hemangiomas</brief_title>
  <official_title>Optical Tomographic Imaging of Infantile Hemangiomas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesize that there are differences between infantile hemangiomas (IH)&#xD;
      during the proliferating and involuting phases and in response to medical treatment that can&#xD;
      be detected by optical tomography of these hemangiomas.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Infantile hemangiomas (IH) are common vascular growths that frequently arise in infants. The&#xD;
      clinical presentation is variable, and some hemangiomas have the potential to cause&#xD;
      disfiguring and even lifethreatening complications. While there is no FDA approved treatment&#xD;
      for IH, certain medications have been shown to be effective in shrinking the growths.&#xD;
      Unfortunately, there is no objective tool to monitor IH or to guide treatment. Such a tool&#xD;
      would improve the management of these patients. A new handheld wireless device uses diffuse&#xD;
      optical imaging (DOI) technology to measure blood flow characteristics.&#xD;
&#xD;
      The device has been used in studies to assess patients with breast cancer. Optical tomography&#xD;
      has also been increasingly used to assess neurological function and pathology in newborn&#xD;
      infants.&#xD;
&#xD;
      The goal of the investigators' study is to assess the utility of DOI for characterizing and&#xD;
      monitoring IH. Fifteen IH will be assessed at three points in time as part of this study,&#xD;
      comprising two groups: 'Natural History' and 'Treatment'. DOI measurements will be correlated&#xD;
      with clinical findings and existing ultrasound measurements of the IH.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">January 1, 2018</completion_date>
  <primary_completion_date type="Actual">January 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in absolute total hemoglobin concentration ([THb]) of hemangioma and normal skin.</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Measurements of absolute total hemoglobin concentration ([THb]) of hemangioma and normal skin are obtained using a diffuse optical imaging device and are compared at different time points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in tissue oxygen saturation (StO2) of hemangioma and normal skin.</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Measurements of tissue oxygen saturation (StO2) of hemangioma and normal skin are obtained using a diffuse optical imaging device and are compared at different time points.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in absolute total hemoglobin concentration ([THb]) of hemangioma at different time points.</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Measurements of absolute total hemoglobin concentration ([THb]) of the hemangioma are obtained at different time points and compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in tissue oxygen saturation (StO2) of the hemangioma at different time points.</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Measurements of tissue oxygen saturation (StO2) of the hemangioma are obtained at different time points and compared.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">15</enrollment>
  <condition>Infantile Hemangioma</condition>
  <arm_group>
    <arm_group_label>Natural History</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All subjects will be recruited verbally from the pediatric dermatology faculty practices,&#xD;
        clinics and inpatient services at CUMC/NYP (MSCHONY). In accordance with CUMC policy,&#xD;
        researchers will not approach a patient for recruitment until that patient has been&#xD;
        informed of the study by their treating physician who has ascertained the patient's&#xD;
        willingness to discuss the study with the investigators.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        For the 'Natural History' Cohort, the following inclusion and exclusion criteria apply:&#xD;
&#xD;
        INCLUSION CRITERIA:&#xD;
&#xD;
          -  Infants with IH who present to our practices within the first 2 months of life.&#xD;
&#xD;
          -  IH of size &gt; 2 cm in diameter&#xD;
&#xD;
          -  IH located on area of skin that is accessible to contact by 4x2cm probe. Examples&#xD;
             include the lateral face, forehead, scalp, trunk and areas of the extremities not&#xD;
             overlying joints.&#xD;
&#xD;
        Infants with IH that do not necessitate either medical or surgical intervention at time of&#xD;
        presentation.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          -  IH of size &lt;2 cm in diameter&#xD;
&#xD;
          -  Complicated IH requiring medical or surgical intervention&#xD;
&#xD;
          -  IH located within 2 cm of the eye&#xD;
&#xD;
        For the 'Treatment' Cohort, the following inclusion and exclusion criteria apply:&#xD;
&#xD;
        INCLUSION CRITERIA:&#xD;
&#xD;
          -  Infants with IH who present to our practices within the first 2 months of life.&#xD;
&#xD;
          -  IH of size &gt;2 cm in diameter&#xD;
&#xD;
          -  IH located on area of skin that is accessible to contact by 4x2cm probe. Examples&#xD;
             include the lateral face, forehead,scalp, trunk and areas of the extremities not&#xD;
             overlying joints.&#xD;
&#xD;
          -  IH that necessitate medical intervention with either oral or topical betablockers.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          -  IH &lt;2 cm in size&#xD;
&#xD;
          -  Complicated IH requiring surgical intervention&#xD;
&#xD;
          -  IH located within 2 cm of the eye&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Garzon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University Medical Center / Department of Dermatology</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>August 3, 2018</last_update_submitted>
  <last_update_submitted_qc>August 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Maria Garzon</investigator_full_name>
    <investigator_title>Professor of Clinical Dermatology and Clinical Pediatrics</investigator_title>
  </responsible_party>
  <keyword>hemangioma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemangioma</mesh_term>
    <mesh_term>Hemangioma, Capillary</mesh_term>
    <mesh_term>Port-Wine Stain</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/NCT01673971
org study id: AAAJ1201
nct id: NCT01673971
lead sponsor: 
has dmc: Yes
The investigators hypothesize that there are differences between infantile hemangiomas (IH)
      during the proliferating and involuting phases and in response to medical treatment that can
      be detected by optical tomography of these hemangiomas.
Infantile hemangiomas (IH) are common vascular growths that frequently arise in infants. The
      clinical presentation is variable, and some hemangiomas have the potential to cause
      disfiguring and even lifethreatening complications. While there is no FDA approved treatment
      for IH, certain medications have been shown to be effective in shrinking the growths.
      Unfortunately, there is no objective tool to monitor IH or to guide treatment. Such a tool
      would improve the management of these patients. A new handheld wireless device uses diffuse
      optical imaging (DOI) technology to measure blood flow characteristics.

      The device has been used in studies to assess patients with breast cancer. Optical tomography
      has also been increasingly used to assess neurological function and pathology in newborn
      infants.

      The goal of the investigators' study is to assess the utility of DOI for characterizing and
      monitoring IH. Fifteen IH will be assessed at three points in time as part of this study,
      comprising two groups: 'Natural History' and 'Treatment'. DOI measurements will be correlated
      with clinical findings and existing ultrasound measurements of the IH.
observational model: Cohort
time perspective: Other
measure: Difference in absolute total hemoglobin concentration ([THb]) of hemangioma and normal skin.
time frame: Up to 2 years
description: Measurements of absolute total hemoglobin concentration ([THb]) of hemangioma and normal skin are obtained using a diffuse optical imaging device and are compared at different time points.
measure: Difference in tissue oxygen saturation (StO2) of hemangioma and normal skin.
time frame: Up to 2 years
description: Measurements of tissue oxygen saturation (StO2) of hemangioma and normal skin are obtained using a diffuse optical imaging device and are compared at different time points.
measure: Difference in absolute total hemoglobin concentration ([THb]) of hemangioma at different time points.
time frame: Up to 2 years
description: Measurements of absolute total hemoglobin concentration ([THb]) of the hemangioma are obtained at different time points and compared.
measure: Difference in tissue oxygen saturation (StO2) of the hemangioma at different time points.
time frame: Up to 2 years
description: Measurements of tissue oxygen saturation (StO2) of the hemangioma are obtained at different time points and compared.
arm group label: Natural History
arm group label: Treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 7 Years
healthy volunteers: No
last name: Maria Garzon, MD
role: Principal Investigator
affiliation: Columbia University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Maria Garzon
investigator title: Professor of Clinical Dermatology and Clinical Pediatrics
mesh term: Hemangioma
mesh term: Hemangioma, Capillary
mesh term: Port-Wine Stain