<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/NCT03297957</url>
  </required_header>
  <id_info>
    <org_study_id>201708068</org_study_id>
    <nct_id>NCT03297957</nct_id>
  </id_info>
  <brief_title>Fluorescence Imaging in Head and Neck Cancer</brief_title>
  <official_title>Evaluation of Fluorescence Imaging in Head and Neck Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fluorescent technology continues to advance in the detection of sentinel lymph nodes (SLNs).&#xD;
      Currently, this requires switching from near-infrared light to white light to be able to&#xD;
      identify the fluorescent tissue contrasting with normal surrounding tissue. Currently, no&#xD;
      system has been studied specifically for head and neck sentinel lymph node biopsies using a&#xD;
      hands free goggle system that can visualize white light (normal surgical visualization) and&#xD;
      nearinfrared light (ICG fluorescence) simultaneously. This technology may have implications&#xD;
      on the safety and accuracy of sentinel lymph node biopsy for head and neck mucosal and&#xD;
      cutaneous tumors. Secondarily, this may reduce operative costs by decreasing the amount of&#xD;
      time required to perform the SLNB procedure.&#xD;
&#xD;
      Regarding parathyroid identification, this technology has the potential to identify these&#xD;
      very small glands during procedures they are at risk. These glands are not only at risk of&#xD;
      inadvertent removal if not adequately identified, but may also be at risk if devascularized&#xD;
      by manipulation during the surgical procedure. Therefore, early and accurate identification&#xD;
      may decrease the rate of temporary and permanent hypoparathyroidism and hypocalcemia. This is&#xD;
      not only an issue during thyroid and parathyroid surgery, but during laryngectomy surgery&#xD;
      where the anatomic region these glands are located are often resected to remove at risk lymph&#xD;
      nodes from cancer spread. Therefore, identifying these glands may help preserve parathyroid&#xD;
      function in this patient population as well.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low accrual&#xD;
  </why_stopped>
  <start_date type="Actual">September 14, 2017</start_date>
  <completion_date type="Actual">April 15, 2019</completion_date>
  <primary_completion_date type="Actual">April 15, 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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure</measure>
    <time_frame>Up to 1 week after surgery</time_frame>
    <description>-Feasibility will be assessed in terms of percentage of patients enrolled for whom peri-tumoral injection with ICG is performed successfully</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure</measure>
    <time_frame>Up to 1 week after surgery</time_frame>
    <description>-Feasibility will be assessed in terms of percentage patients whom the sentinel and superficial lymph nodes will be detected from the hands free goggle device</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure</measure>
    <time_frame>Up to 1 week after surgery</time_frame>
    <description>-Feasibility will be assessed in terms of percentage of total lesions identified from the new technique are truly positive as confirmed by biopsy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure</measure>
    <time_frame>Up to 1 week after surgery</time_frame>
    <description>-Feasibility will be assessed in terms of the the percentage of total positive SNLs being missed from the new device</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ability of the hands-free goggle system to identify parathryoid glands during central neck surgeries</measure>
    <time_frame>Up to 1 week after surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determine if there is contrast between SLN and surrounding tissues using the novel fluorescence imaging device</measure>
    <time_frame>Up to 1 week after surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Head and Neck Cancer</condition>
  <condition>Cancer of the Head and Neck</condition>
  <arm_group>
    <arm_group_label>Arm 1: Goggle Imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>-Patient will then be taken to the operating room for this surgical procedure. Prior to starting the operation, the patient will undergo injection of ICG around the tumor per standard techniques while in the operating room. Those undergoing intraoperative visualization of parathyroid glands will not have any administration of ICG as these glands autofluoresce. Patients will then undergo the standard SLN biopsy procedure (those undergoing parathyroid visualization will not undergo this). The surgeon will put on the goggle system to attempt to identify the SLN using fluorescence guidance or parathryroid visualization. After this is performed, the goggle system will be removed and the procedure will be completed per normal.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hands-free goggle system</intervention_name>
    <description>-Manufactured at Washington University</description>
    <arm_group_label>Arm 1: Goggle Imaging</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 18 years or older will be considered eligible.&#xD;
&#xD;
          -  Patients with head and neck malignancies, such as melanoma, non-melanoma cutaneous&#xD;
             malignancies, or oral cavity squamous cell carcinoma. Patients with central neck&#xD;
             pathology including thyroid neoplasms, parathyroid neoplasms, and laryngeal neoplasms&#xD;
             undergoing surgical resection.&#xD;
&#xD;
               -  Candidates for sentinel lymph node biopsy or central neck surgery&#xD;
&#xD;
               -  Newly diagnosed with clinically node negative head and neck cancer being staged&#xD;
                  with sentinel lymph node biopsy.&#xD;
&#xD;
          -  Not pregnant or breast feeding.&#xD;
&#xD;
          -  Able to understand and willing to sign an IRB-approved written informed consent&#xD;
             document.&#xD;
&#xD;
          -  Able to understand written or spoken English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of allergy to iodide drugs or shellfish (iodine allergy)&#xD;
&#xD;
          -  Pregnant or breast feeding&#xD;
&#xD;
          -  Do not fit age criteria&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Unable to provide written consent&#xD;
&#xD;
          -  Contraindications for surgery&#xD;
&#xD;
             *Presence of uncontrolled intercurrent illness including, but not limited to, ongoing&#xD;
             or active infection of the head and neck, symptomatic congestive heart failure,&#xD;
             unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations&#xD;
             that would limit compliance with study requirements&#xD;
&#xD;
          -  Receiving any other investigational agents&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ryan S Jackson, 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>January 2020</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>January 15, 2020</last_update_submitted>
  <last_update_submitted_qc>January 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
  </condition_browse>
  <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/NCT03297957
org study id: 201708068
nct id: NCT03297957
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Fluorescent technology continues to advance in the detection of sentinel lymph nodes (SLNs).
      Currently, this requires switching from near-infrared light to white light to be able to
      identify the fluorescent tissue contrasting with normal surrounding tissue. Currently, no
      system has been studied specifically for head and neck sentinel lymph node biopsies using a
      hands free goggle system that can visualize white light (normal surgical visualization) and
      nearinfrared light (ICG fluorescence) simultaneously. This technology may have implications
      on the safety and accuracy of sentinel lymph node biopsy for head and neck mucosal and
      cutaneous tumors. Secondarily, this may reduce operative costs by decreasing the amount of
      time required to perform the SLNB procedure.

      Regarding parathyroid identification, this technology has the potential to identify these
      very small glands during procedures they are at risk. These glands are not only at risk of
      inadvertent removal if not adequately identified, but may also be at risk if devascularized
      by manipulation during the surgical procedure. Therefore, early and accurate identification
      may decrease the rate of temporary and permanent hypoparathyroidism and hypocalcemia. This is
      not only an issue during thyroid and parathyroid surgery, but during laryngectomy surgery
      where the anatomic region these glands are located are often resected to remove at risk lymph
      nodes from cancer spread. Therefore, identifying these glands may help preserve parathyroid
      function in this patient population as well.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure
time frame: Up to 1 week after surgery
description: -Feasibility will be assessed in terms of percentage of patients enrolled for whom peri-tumoral injection with ICG is performed successfully
measure: Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure
time frame: Up to 1 week after surgery
description: -Feasibility will be assessed in terms of percentage patients whom the sentinel and superficial lymph nodes will be detected from the hands free goggle device
measure: Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure
time frame: Up to 1 week after surgery
description: -Feasibility will be assessed in terms of percentage of total lesions identified from the new technique are truly positive as confirmed by biopsy
measure: Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure
time frame: Up to 1 week after surgery
description: -Feasibility will be assessed in terms of the the percentage of total positive SNLs being missed from the new device
measure: Ability of the hands-free goggle system to identify parathryoid glands during central neck surgeries
time frame: Up to 1 week after surgery
measure: Determine if there is contrast between SLN and surrounding tissues using the novel fluorescence imaging device
time frame: Up to 1 week after surgery
arm group label: Arm 1: Goggle Imaging
arm group type: Experimental
description: -Patient will then be taken to the operating room for this surgical procedure. Prior to starting the operation, the patient will undergo injection of ICG around the tumor per standard techniques while in the operating room. Those undergoing intraoperative visualization of parathyroid glands will not have any administration of ICG as these glands autofluoresce. Patients will then undergo the standard SLN biopsy procedure (those undergoing parathyroid visualization will not undergo this). The surgeon will put on the goggle system to attempt to identify the SLN using fluorescence guidance or parathryroid visualization. After this is performed, the goggle system will be removed and the procedure will be completed per normal.
intervention type: Device
intervention name: Hands-free goggle system
description: -Manufactured at Washington University
arm group label: Arm 1: Goggle Imaging
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ryan S Jackson, 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
mesh term: Head and Neck Neoplasms
sharing ipd: No