<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/NCT03262818</url>
  </required_header>
  <id_info>
    <org_study_id>201608016</org_study_id>
    <secondary_id>5R01CA151570-02</secondary_id>
    <nct_id>NCT03262818</nct_id>
  </id_info>
  <brief_title>Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary</brief_title>
  <official_title>Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators have developed co-registered photoacoustic and ultrasound (US) imaging&#xD;
      technique that allows the investigators to visualize tumor structure and functional changes&#xD;
      simultaneously, which may potentially reveal early tumor angiogenesis development that is not&#xD;
      available by US alone. The ability to detect early angiogenesis changes, as well as tumor&#xD;
      morphology changes in the ovary, using a non-invasive imaging modality will greatly enhance&#xD;
      the care for women.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">November 20, 2018</completion_date>
  <primary_completion_date type="Actual">November 19, 2018</primary_completion_date>
  <phase>Phase 1</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measure PAI/ultrasound signatures from ovaries prior to surgery</measure>
    <time_frame>Prior to surgery (no more than 30 days prior to surgery)</time_frame>
    <description>-The transvaginal US will be performed by US technologists or radiologists at the Radiology Department and images will be read by one of the study radiologists either Dr. Cary Siegel or Dr. Kathryn Robinson of the Radiology Department. The reading will be categorized as normal, suspicious or highly suspicious. The scores will serve as a baseline comparison of US/PAI technique with the current clinical practice using US. Immediately after the transvaginal US, US/PAI imaging will be performed with the assistance of the US technologist or radiologist.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Characterize the tissue images with pathologic diagnosis</measure>
    <time_frame>At the time of surgery (no more than 30 days after PAI/US)</time_frame>
    <description>-The in vivo and ex vivo PAI/US images with be compared with final pathologic diagnosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Refine the system and imaging algorithms based on the characteristic features of in vivo imaging</measure>
    <time_frame>At the time of surgery (no more than 30 days after PAI/US)</time_frame>
    <description>-Will be used to distinguish between benign and malignant ovarian tissues. Student t-test will be used for statistical significant test of each feature obtained from malignant and benign ovaries. Those features with p value less than 0.05 will be used as a predictor.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Oophorectomy</condition>
  <arm_group>
    <arm_group_label>Transvaginal Ultrasound + Ultrasound/Photoacoustic imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transvaginal ultrasound (US) prior to surgery&#xD;
Immediately after the transvaginal US, US/PAI imaging will be performed&#xD;
Once the surgeon has removed the ovary(ies) they will be imaged ex vivo. The in vivo and ex vivo US/PAI images will be compared with the final pathologic diagnosis</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transvaginal ultrasound</intervention_name>
    <description>-Will be performed by US technologists at Washington University School of Medicine and read by Dr. Cary Siegel or Dr. Kathryn Robinson</description>
    <arm_group_label>Transvaginal Ultrasound + Ultrasound/Photoacoustic imaging</arm_group_label>
    <other_name>Transvaginal US</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound/Photoacoustic imaging</intervention_name>
    <description>-The light illumination for the photoacoustic imaging system is provided by a wavelength-tunable Ti:Sapphire laser (LOTIS TII), optically pumped by an Nd:YAG laser (LOTIS TII) at 532 nm wavelength.</description>
    <arm_group_label>Transvaginal Ultrasound + Ultrasound/Photoacoustic imaging</arm_group_label>
    <other_name>US/PAI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Referred to Washington University School of Medicine for conditions necessitating&#xD;
             surgery to include at least a unilateral oophorectomy&#xD;
&#xD;
          -  Willingness to participate in the study&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Younger than 18 years of age&#xD;
&#xD;
          -  Not able to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cary L Siegel, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.siteman.wustl.edu</url>
    <description>Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine</description>
  </link>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>November 20, 2018</last_update_submitted>
  <last_update_submitted_qc>November 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03262818
org study id: 201608016
secondary id: 5R01CA151570-02
nct id: NCT03262818
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The investigators have developed co-registered photoacoustic and ultrasound (US) imaging
      technique that allows the investigators to visualize tumor structure and functional changes
      simultaneously, which may potentially reveal early tumor angiogenesis development that is not
      available by US alone. The ability to detect early angiogenesis changes, as well as tumor
      morphology changes in the ovary, using a non-invasive imaging modality will greatly enhance
      the care for women.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Measure PAI/ultrasound signatures from ovaries prior to surgery
time frame: Prior to surgery (no more than 30 days prior to surgery)
description: -The transvaginal US will be performed by US technologists or radiologists at the Radiology Department and images will be read by one of the study radiologists either Dr. Cary Siegel or Dr. Kathryn Robinson of the Radiology Department. The reading will be categorized as normal, suspicious or highly suspicious. The scores will serve as a baseline comparison of US/PAI technique with the current clinical practice using US. Immediately after the transvaginal US, US/PAI imaging will be performed with the assistance of the US technologist or radiologist.
measure: Characterize the tissue images with pathologic diagnosis
time frame: At the time of surgery (no more than 30 days after PAI/US)
description: -The in vivo and ex vivo PAI/US images with be compared with final pathologic diagnosis.
measure: Refine the system and imaging algorithms based on the characteristic features of in vivo imaging
time frame: At the time of surgery (no more than 30 days after PAI/US)
description: -Will be used to distinguish between benign and malignant ovarian tissues. Student t-test will be used for statistical significant test of each feature obtained from malignant and benign ovaries. Those features with p value less than 0.05 will be used as a predictor.
arm group label: Transvaginal Ultrasound + Ultrasound/Photoacoustic imaging
arm group type: Experimental
description: Transvaginal ultrasound (US) prior to surgery
Immediately after the transvaginal US, US/PAI imaging will be performed
Once the surgeon has removed the ovary(ies) they will be imaged ex vivo. The in vivo and ex vivo US/PAI images will be compared with the final pathologic diagnosis
intervention type: Device
intervention name: Transvaginal ultrasound
description: -Will be performed by US technologists at Washington University School of Medicine and read by Dr. Cary Siegel or Dr. Kathryn Robinson
arm group label: Transvaginal Ultrasound + Ultrasound/Photoacoustic imaging
other name: Transvaginal US
intervention type: Device
intervention name: Ultrasound/Photoacoustic imaging
description: -The light illumination for the photoacoustic imaging system is provided by a wavelength-tunable Ti:Sapphire laser (LOTIS TII), optically pumped by an Nd:YAG laser (LOTIS TII) at 532 nm wavelength.
arm group label: Transvaginal Ultrasound + Ultrasound/Photoacoustic imaging
other name: US/PAI
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cary L Siegel, M.D.
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
country: United States
url: http://www.siteman.wustl.edu
description: Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
responsible party type: Sponsor
sharing ipd: No