<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/NCT02191488</url>
  </required_header>
  <id_info>
    <org_study_id>DMS 13066</org_study_id>
    <secondary_id>R01NS052274-01A2</secondary_id>
    <nct_id>NCT02191488</nct_id>
  </id_info>
  <brief_title>ALA-induced PpIX Fluorescence During Brain Tumor Resection</brief_title>
  <official_title>Quantification of ALA-induced PpIX Fluorescence During Brain Tumor Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>David W. Roberts</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Dartmouth-Hitchcock Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Removing a tumor from a patients brain is hard to do because, very often, brain tumors do not&#xD;
      have boundaries that are easy for the patients surgeon to find. In many cases, the surgeon&#xD;
      can't tell exactly where the tumor begins or ends. The surgeon usually can remove most of the&#xD;
      patient's tumor by looking at the MRI images that were taken of the patient's brain before&#xD;
      surgery. However, the surgeon does not have any good way to tell if the entire tumor has been&#xD;
      removed or not. Removing the entire tumor is very important because leaving tumor behind may&#xD;
      allow it to grow back which could decrease the chances of survival.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Anticipated">July 2026</completion_date>
  <primary_completion_date type="Anticipated">July 2025</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>Comparison of intraoperative measurements of PpIX concentration to coregistered histopathology</measure>
    <time_frame>Up to five years from the first surgery date</time_frame>
    <description>To estimate the probability of tumor distribution for a given PpIX concentration by comparing intraoperative measurements with coregistered histopathology obtained from biopsy sampling during the procedure</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">540</enrollment>
  <condition>Brain Tumors</condition>
  <arm_group>
    <arm_group_label>Experimental: 5-aminolevulinic acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20mg/kg 3 hours prior to surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5-aminolevulinic acid</intervention_name>
    <arm_group_label>Experimental: 5-aminolevulinic acid</arm_group_label>
    <other_name>5-ALA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Preoperative diagnosis of either presumed first-time low or high grade glioma, or&#xD;
             recurrent glioma, or metastasis, or meningioma&#xD;
&#xD;
          -  Tumor judged to be suitable for open cranial resection based on preoperative imaging&#xD;
             studies.&#xD;
&#xD;
          -  Patient or LAR able to provide written informed consent.&#xD;
&#xD;
          -  No serious associated psychiatric illnesses.&#xD;
&#xD;
          -  Age &gt; 21 years old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women or women who are breast feeding&#xD;
&#xD;
          -  History of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins,&#xD;
             photodermatosis, exfoliative dermatitis.&#xD;
&#xD;
          -  History of liver disease within the last 12 months.&#xD;
&#xD;
          -  Elevated liver function levels greater than 2.5 times the normal limit from laboratory&#xD;
             tests conducted within 30 days prior to surgery.&#xD;
&#xD;
          -  Inability to comply with the photosensitivity precautions associated with the study.&#xD;
&#xD;
          -  Plasma creatinine in excess of 180umol/L within 30 days prior to surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David W. Roberts, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dartmouth-Hitchcock Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>May 16, 2023</last_update_submitted>
  <last_update_submitted_qc>May 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Dartmouth-Hitchcock Medical Center</investigator_affiliation>
    <investigator_full_name>David W. Roberts</investigator_full_name>
    <investigator_title>Professor of Surgery (Neurosurgery)</investigator_title>
  </responsible_party>
  <keyword>Fluorescence</keyword>
  <keyword>Brain Tumors</keyword>
  <keyword>Brain Metastases</keyword>
  <keyword>Malignant Glioma</keyword>
  <keyword>Brain Lesions</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aminolevulinic Acid</mesh_term>
  </intervention_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/NCT02191488
org study id: DMS 13066
secondary id: R01NS052274-01A2
nct id: NCT02191488
lead sponsor: 
collaborator: 
has dmc: Yes
Removing a tumor from a patients brain is hard to do because, very often, brain tumors do not
      have boundaries that are easy for the patients surgeon to find. In many cases, the surgeon
      can't tell exactly where the tumor begins or ends. The surgeon usually can remove most of the
      patient's tumor by looking at the MRI images that were taken of the patient's brain before
      surgery. However, the surgeon does not have any good way to tell if the entire tumor has been
      removed or not. Removing the entire tumor is very important because leaving tumor behind may
      allow it to grow back which could decrease the chances of survival.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Comparison of intraoperative measurements of PpIX concentration to coregistered histopathology
time frame: Up to five years from the first surgery date
description: To estimate the probability of tumor distribution for a given PpIX concentration by comparing intraoperative measurements with coregistered histopathology obtained from biopsy sampling during the procedure
arm group label: Experimental: 5-aminolevulinic acid
arm group type: Experimental
description: 20mg/kg 3 hours prior to surgery
intervention type: Drug
intervention name: 5-aminolevulinic acid
arm group label: Experimental: 5-aminolevulinic acid
other name: 5-ALA
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: David W. Roberts, MD
role: Principal Investigator
affiliation: Dartmouth-Hitchcock Medical Center
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Dartmouth-Hitchcock Medical Center
investigator full name: David W. Roberts
investigator title: Professor of Surgery (Neurosurgery)
mesh term: Brain Neoplasms
mesh term: Aminolevulinic Acid