<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/NCT02975219</url>
  </required_header>
  <id_info>
    <org_study_id>2016/304</org_study_id>
    <nct_id>NCT02975219</nct_id>
  </id_info>
  <brief_title>Feasibility Study of Using Molecular Fluorescence Guided Surgery in Endometriosis</brief_title>
  <acronym>Endo-light</acronym>
  <official_title>Determine the Feasibility of Detecting Endometriosis During Surgery Using a Molecular Targeted Fluorescent Imaging Tracer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Center Groningen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medical Center Groningen</source>
  <oversight_info>
    <has_dmc>No</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>
      Incomplete resection of endometriosis lesions often results in recurrence of symptoms and the&#xD;
      need for repeated surgery, with considerable associated morbidity. The aim of this pilot&#xD;
      project is to determine the feasibility of fluorescence imaging to improve the treatment of&#xD;
      endometriosis in the future.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Anticipated">January 2019</completion_date>
  <primary_completion_date type="Anticipated">January 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tracer accumulation of bevacizumab-800cw in endometriosis lesions assessed by ex vivo measurement of the mean fluorescent intensity correlated to histopathology</measure>
    <time_frame>within 6 months after surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related adverse events</measure>
    <time_frame>within two weeks after tracer injection</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Endometriosis</condition>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4.5mg Bevacizumab-800CW intravenously</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bevacizumab-800CW</intervention_name>
    <description>4.5mg Bevacizumab-800CW will be administered intravenously three days prior to surgery</description>
    <arm_group_label>Treatment group</arm_group_label>
    <other_name>Bevacizumab-IRDye800CW</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Females aged ≥ 18 years&#xD;
&#xD;
          2. Scheduled for surgery for the treatment of endometriosis&#xD;
&#xD;
          3. WHO performance score of 0-2&#xD;
&#xD;
          4. Written informed consent&#xD;
&#xD;
             For female subjects who are of childbearing potential, are premenopausal with intact&#xD;
             reproductive organs or are less than 2 years post-menopausal:&#xD;
&#xD;
          5. A negative serum pregnancy test prior to receiving the tracer&#xD;
&#xD;
          6. Willing to ensure that she or her partner uses effective contraception during the&#xD;
             trial and for 6 months thereafter.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Medical or psychiatric conditions that compromise the patient's ability to give&#xD;
             informed consent&#xD;
&#xD;
          2. Pregnancy&#xD;
&#xD;
          3. History of infusion reactions to Bevacizumab or other monoclonal antibody therapies&#xD;
&#xD;
          4. Significant renal, cardiac, or pulmonary disease (ASA III-IV)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gooitzen van Dam, prof dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>UMCG</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gooitzen van Dam, prof dr</last_name>
    <phone>0503610183</phone>
    <email>g.m.van.dam@umcg.nl</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Medical Center Groningen</name>
      <address>
        <city>Groningen</city>
        <zip>9713 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Go M. van Dam, MD, PhD</last_name>
      <phone>+31 50 361 0183</phone>
      <email>g.m.van.dam@umcg.nl</email>
    </contact>
    <investigator>
      <last_name>Go M. van Dam, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>June 26, 2017</last_update_submitted>
  <last_update_submitted_qc>June 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Center Groningen</investigator_affiliation>
    <investigator_full_name>G.M. van Dam</investigator_full_name>
    <investigator_title>prof. dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bevacizumab</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/NCT02975219
org study id: 2016/304
nct id: NCT02975219
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Incomplete resection of endometriosis lesions often results in recurrence of symptoms and the
      need for repeated surgery, with considerable associated morbidity. The aim of this pilot
      project is to determine the feasibility of fluorescence imaging to improve the treatment of
      endometriosis in the future.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tracer accumulation of bevacizumab-800cw in endometriosis lesions assessed by ex vivo measurement of the mean fluorescent intensity correlated to histopathology
time frame: within 6 months after surgery
measure: Number of participants with treatment-related adverse events
time frame: within two weeks after tracer injection
arm group label: Treatment group
arm group type: Experimental
description: 4.5mg Bevacizumab-800CW intravenously
intervention type: Drug
intervention name: Bevacizumab-800CW
description: 4.5mg Bevacizumab-800CW will be administered intravenously three days prior to surgery
arm group label: Treatment group
other name: Bevacizumab-IRDye800CW
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Gooitzen van Dam, prof dr
role: Principal Investigator
affiliation: UMCG
last name: Gooitzen van Dam, prof dr
phone: 0503610183
email: g.m.van.dam@umcg.nl
facility: 
status: Recruiting
contact: 
investigator: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: University Medical Center Groningen
investigator full name: G.M. van Dam
investigator title: prof. dr.
mesh term: Endometriosis
mesh term: Bevacizumab