<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/NCT03752203</url>
  </required_header>
  <id_info>
    <org_study_id>18-0242.cc</org_study_id>
    <nct_id>NCT03752203</nct_id>
  </id_info>
  <brief_title>Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors</brief_title>
  <official_title>Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sodium fluorescein, which has been shown to be useful for intraoperative guidance regarding&#xD;
      the resection of adult neurosurgical tumors, can aid the resection of pediatric neurosurgical&#xD;
      tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a prospective non-randomized cohort study with patients presenting to&#xD;
      Children's Hospital Colorado for resection of a central nervous system tumor. This study will&#xD;
      employ the use of sodium fluorescein and an FDA approved operative microscope equipped with&#xD;
      excitation and barrier filters for monitoring with sufficient fluorescent enhancement and&#xD;
      contrast. Fluorescein sodium is a small organic salt that accumulates in areas of diminished&#xD;
      blood-brain barrier integrity and allows for determination of the margins between tumor and&#xD;
      normal brain function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 11, 2021</start_date>
  <completion_date type="Actual">August 8, 2023</completion_date>
  <primary_completion_date type="Actual">June 29, 2023</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>
    <intervention_model_description>The primary neurosurgeons who will perform the resections will be investigators on the study and will identify eligible patients from the established practice. At the time surgical intervention is recommended, the doctors will inform patients and parents/guardians of the existence of the study. Only those subjects with a clinical relationship to the study investigators will be recruited.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Since patients are being recruited from the investigators' practices, and there is only one form of treatment, masking will not be utilized.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percent of Tumor Resected: Intracranial Lesions</measure>
    <time_frame>Pre-op assessment to outpatient follow up, up to 6 weeks</time_frame>
    <description>For all patients, pre-operative imaging and post-operative imaging will be used to analyze the extent of resection of the tumors. In intracranial lesions, the use of volumetric imaging tools will be used to calculate the extent of tumor resection.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of Tumor Resected: Spinal Lesions</measure>
    <time_frame>Pre-op assessment to outpatient follow up, up to 6 weeks</time_frame>
    <description>For all patients, pre-operative imaging and post-operative imaging will be used to analyze the extent of resection of the tumors. In spinal lesions, manual measurement will be used to determine the extent of resection.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective Utility</measure>
    <time_frame>Pre-op assessment to outpatient follow up, up to 6 weeks</time_frame>
    <description>The doctor's satisfaction with the resection of the tumor(s) will be based upon pre and post imaging, as well as his or her personal experience.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive Predictive Value</measure>
    <time_frame>Pre-op assessment to outpatient follow up, up to 6 weeks</time_frame>
    <description>PPV will be calculated using contingency tables and the data from the tumor extraction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of Tumor Resection</measure>
    <time_frame>Pre-op assessment to outpatient follow up, up to 6 weeks</time_frame>
    <description>Tissue obtained during the time of surgery will be used to correlate fluorescein staining to histopathological diagnosis to determine sensitivity of fluorescein staining for tumors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of Tumor Resection</measure>
    <time_frame>Pre-op assessment to outpatient follow up, up to 6 weeks</time_frame>
    <description>Tissue obtained during the time of surgery will be used to correlate fluorescein staining to histopathological diagnosis to determine specificity of fluorescein staining for tumors.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Pediatric Neurosurgical Tumors</condition>
  <arm_group>
    <arm_group_label>Sodium-Fluorescein Resection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This study will employ the use of sodium fluorescein and an FDA approved operative microscope equipped with excitation and barrier filters for monitoring with sufficient fluorescent enhancement and contrast.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium Fluorescein</intervention_name>
    <description>Patients enrolled in this study will receive 3 mg/kg sodium fluorescein following induction of anesthesia by administration into a peripheral venous line over 10 seconds</description>
    <arm_group_label>Sodium-Fluorescein Resection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Microscopic Resection</intervention_name>
    <description>Resection will proceed with the use of a surgical microscope equipped with excitation and barrier filters for monitoring with sufficient fluorescent enhancement and contrast.</description>
    <arm_group_label>Sodium-Fluorescein Resection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 31 days through 21 years on date of surgery&#xD;
&#xD;
          -  Undergoing resection of a central nervous system tumor at Children's Hospital Colorado&#xD;
&#xD;
          -  Parent/legal guardian (or adult subject) willing and able to complete the informed&#xD;
             consent process&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Tumor in functionally eloquent cortex that precludes maximal surgical resection&#xD;
&#xD;
          -  Severe renal dysfunction&#xD;
&#xD;
          -  Preoperative serum creatinine level &gt; than normal range and GFR &lt; 30.&#xD;
&#xD;
          -  Severe liver dysfunction&#xD;
&#xD;
          -  History of asthma or pulmonary spasm&#xD;
&#xD;
          -  Known allergy to sodium fluorescein or any other contrast dye&#xD;
&#xD;
          -  Previous administration of sodium fluorescein within the last 72 hours&#xD;
&#xD;
          -  Pregnant or nursing mother&#xD;
&#xD;
          -  Other unspecified reasons that, in the opinion of the investigator, make the subject&#xD;
             unsuitable for enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>31 Days</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Todd Hankinson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Colorado</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>August 11, 2023</last_update_submitted>
  <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sodium Fluorescein</keyword>
  <keyword>Surgical Microscope</keyword>
  <keyword>Central Nervous System</keyword>
  <keyword>Tumors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT03752203
org study id: 18-0242.cc
nct id: NCT03752203
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
Sodium fluorescein, which has been shown to be useful for intraoperative guidance regarding
      the resection of adult neurosurgical tumors, can aid the resection of pediatric neurosurgical
      tumors.
This study will be a prospective non-randomized cohort study with patients presenting to
      Children's Hospital Colorado for resection of a central nervous system tumor. This study will
      employ the use of sodium fluorescein and an FDA approved operative microscope equipped with
      excitation and barrier filters for monitoring with sufficient fluorescent enhancement and
      contrast. Fluorescein sodium is a small organic salt that accumulates in areas of diminished
      blood-brain barrier integrity and allows for determination of the margins between tumor and
      normal brain function.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The primary neurosurgeons who will perform the resections will be investigators on the study and will identify eligible patients from the established practice. At the time surgical intervention is recommended, the doctors will inform patients and parents/guardians of the existence of the study. Only those subjects with a clinical relationship to the study investigators will be recruited.
primary purpose: Basic Science
masking: None (Open Label)
masking description: Since patients are being recruited from the investigators' practices, and there is only one form of treatment, masking will not be utilized.
measure: Percent of Tumor Resected: Intracranial Lesions
time frame: Pre-op assessment to outpatient follow up, up to 6 weeks
description: For all patients, pre-operative imaging and post-operative imaging will be used to analyze the extent of resection of the tumors. In intracranial lesions, the use of volumetric imaging tools will be used to calculate the extent of tumor resection.
measure: Percent of Tumor Resected: Spinal Lesions
time frame: Pre-op assessment to outpatient follow up, up to 6 weeks
description: For all patients, pre-operative imaging and post-operative imaging will be used to analyze the extent of resection of the tumors. In spinal lesions, manual measurement will be used to determine the extent of resection.
measure: Subjective Utility
time frame: Pre-op assessment to outpatient follow up, up to 6 weeks
description: The doctor's satisfaction with the resection of the tumor(s) will be based upon pre and post imaging, as well as his or her personal experience.
measure: Positive Predictive Value
time frame: Pre-op assessment to outpatient follow up, up to 6 weeks
description: PPV will be calculated using contingency tables and the data from the tumor extraction.
measure: Sensitivity of Tumor Resection
time frame: Pre-op assessment to outpatient follow up, up to 6 weeks
description: Tissue obtained during the time of surgery will be used to correlate fluorescein staining to histopathological diagnosis to determine sensitivity of fluorescein staining for tumors.
measure: Specificity of Tumor Resection
time frame: Pre-op assessment to outpatient follow up, up to 6 weeks
description: Tissue obtained during the time of surgery will be used to correlate fluorescein staining to histopathological diagnosis to determine specificity of fluorescein staining for tumors.
arm group label: Sodium-Fluorescein Resection
arm group type: Experimental
description: This study will employ the use of sodium fluorescein and an FDA approved operative microscope equipped with excitation and barrier filters for monitoring with sufficient fluorescent enhancement and contrast.
intervention type: Drug
intervention name: Sodium Fluorescein
description: Patients enrolled in this study will receive 3 mg/kg sodium fluorescein following induction of anesthesia by administration into a peripheral venous line over 10 seconds
arm group label: Sodium-Fluorescein Resection
intervention type: Device
intervention name: Microscopic Resection
description: Resection will proceed with the use of a surgical microscope equipped with excitation and barrier filters for monitoring with sufficient fluorescent enhancement and contrast.
arm group label: Sodium-Fluorescein Resection
criteria: 
gender: All
minimum age: 31 Days
maximum age: 21 Years
healthy volunteers: No
last name: Todd Hankinson, MD
role: Principal Investigator
affiliation: Children's Hospital Colorado
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: No