<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/NCT03017989</url>
  </required_header>
  <id_info>
    <org_study_id>NL54458.068.15</org_study_id>
    <nct_id>NCT03017989</nct_id>
  </id_info>
  <brief_title>ICG-Based Fluorescence Imaging for Intra-operative Detection of Endometriosis</brief_title>
  <official_title>The Use of Indocyanine Green-Based Fluorescence Imaging for Intraoperative Detection of Peritoneal Endometriosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maastricht University Medical Center</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>
      Endometriosis is a common disease for which the current gold standard for diagnosis is a&#xD;
      diagnostic laparoscopy with histologic confirmation. However, during the diagnostic&#xD;
      laparoscopy endometriotic lesions are hard to identify due to the many appearances of&#xD;
      endometriosis. Our hypothesis is that the use of intra-operative near infrared fluorescence&#xD;
      imaging will provide real time image enhancement for the detection of endometriotic lesions&#xD;
      by using the different vasculature in the endometriotic lesions. This hypothesis will be&#xD;
      tested in a prospective study with 15 patients scheduled for an elective diagnostic&#xD;
      laparoscopy for suspected endometriosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Actual">January 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>Number of detected endometriotic lesions with Near Infrared Light versus with white light</measure>
    <time_frame>during surgery</time_frame>
    <description>The number of lesions detected in near-infrared light will be compared to the number of endometriotic lesions seen in white light. Hereby, we aim to investigate whether all lesions seen in white light are also seen in NIRF light and whether NIRF light shows endometriotic lesions that were not visible in white light.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Histological assessment of taken biopsies: assessment of localization of ICG uptake</measure>
    <time_frame>biopsies taken during surgery, which are assessed during the 1th week after surgery</time_frame>
    <description>Hereby, we aim to investigate whether the different histological subtypes of endometriosis light up differently in NIRF light. We interested in whether there is another localisation of ICG uptake at cellular level in the different histological subtypes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time measurement</measure>
    <time_frame>during the laparoscopic procedure</time_frame>
    <description>measuring the total operating time, and the extra time needed for fluorescence imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of the procedure: assessment of complications during the procedure attributable to the technique or dye</measure>
    <time_frame>during surgery</time_frame>
    <description>Complications during the diagnostic laparoscopy attributable to the imaging technique or dye are described here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction of the surgeon with the technique</measure>
    <time_frame>immediately after surgery</time_frame>
    <description>Immediately the surgeon will be asked whether he/she considered the use of NIRF imaging an useful additive to the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Histological assessment of taken biopsies: assessment Target to background ratio</measure>
    <time_frame>biopsies taken during surgery, which are assessed during the 1th week after surgery</time_frame>
    <description>The biopsies taken during surgery will be analysed together with the video recordings. Hereby, we aim to investigate whether the different histological subtypes of endometriosis light up differently in NIRF light. We interested in whether there is another target to background rato in the different histological subtypes.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Endometriosis</condition>
  <arm_group>
    <arm_group_label>NIRF imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After the white light (WL) imaging, NIRF imaging will be performed. 2.5 mg of ICG will be administered i.v. up to 5 times if needed. The lesions identified in WL, are inspected in NIRF mode. The surgeon indicated whether the lesions are more easily identified in WL or the NIRF mode and scores the visibility on a 1-10 scale. Next, inspection will take place for lesions that are seen in NIRF mode but not in WL. Biopsies will be taken from the lesions and from normal tissue for reference and sent for histology. Evaluation will take place whether the lesions differ in histological characteristics</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NIRF imaging</intervention_name>
    <description>By using a fluorescence imaging device (with an adapted light source and camera), a fluorescent dye can be made visible. By injecting the fluorescent dye intravenously, the vascularization will be visible. Thereby, structures with altered vascularization are expected to 'light up' differently than the surrounding.</description>
    <arm_group_label>NIRF imaging</arm_group_label>
    <other_name>Near infrared fluorescence imaging</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for elective laparoscopic surgery in which endometriosis is&#xD;
             suspected&#xD;
&#xD;
          -  Able to understand the nature of the study and what will be required of them&#xD;
&#xD;
          -  Females&#xD;
&#xD;
          -  Age &gt;18years&#xD;
&#xD;
          -  Premenopausal&#xD;
&#xD;
          -  No history of impaired liver and renal function&#xD;
&#xD;
          -  No history of hypersensitivity or allergy to indocyanine green or iodide&#xD;
&#xD;
          -  No hyper-thyroidism or autonomic thyroid adenomas&#xD;
&#xD;
          -  Willing to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not able to give written informed consent&#xD;
&#xD;
          -  Males&#xD;
&#xD;
          -  Aged &lt; 18 years&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Known hypersensitivity or allergy to indocyanine green or iodide&#xD;
&#xD;
          -  Known hyper-thyroidism or autonomic thyroid adenomas&#xD;
&#xD;
          -  Not willing to participate&#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>Laurents Stassen, M.D, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maastricht University Medical Center</name>
      <address>
        <city>Maastricht</city>
        <state>Limburg</state>
        <zip>6202</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>March 6, 2019</last_update_submitted>
  <last_update_submitted_qc>March 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Near Infrared Fluorescence Imaging</keyword>
  <keyword>Indocyanine green (ICG)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03017989
org study id: NL54458.068.15
nct id: NCT03017989
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Endometriosis is a common disease for which the current gold standard for diagnosis is a
      diagnostic laparoscopy with histologic confirmation. However, during the diagnostic
      laparoscopy endometriotic lesions are hard to identify due to the many appearances of
      endometriosis. Our hypothesis is that the use of intra-operative near infrared fluorescence
      imaging will provide real time image enhancement for the detection of endometriotic lesions
      by using the different vasculature in the endometriotic lesions. This hypothesis will be
      tested in a prospective study with 15 patients scheduled for an elective diagnostic
      laparoscopy for suspected endometriosis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of detected endometriotic lesions with Near Infrared Light versus with white light
time frame: during surgery
description: The number of lesions detected in near-infrared light will be compared to the number of endometriotic lesions seen in white light. Hereby, we aim to investigate whether all lesions seen in white light are also seen in NIRF light and whether NIRF light shows endometriotic lesions that were not visible in white light.
measure: Histological assessment of taken biopsies: assessment of localization of ICG uptake
time frame: biopsies taken during surgery, which are assessed during the 1th week after surgery
description: Hereby, we aim to investigate whether the different histological subtypes of endometriosis light up differently in NIRF light. We interested in whether there is another localisation of ICG uptake at cellular level in the different histological subtypes.
measure: Time measurement
time frame: during the laparoscopic procedure
description: measuring the total operating time, and the extra time needed for fluorescence imaging
measure: Safety of the procedure: assessment of complications during the procedure attributable to the technique or dye
time frame: during surgery
description: Complications during the diagnostic laparoscopy attributable to the imaging technique or dye are described here.
measure: Satisfaction of the surgeon with the technique
time frame: immediately after surgery
description: Immediately the surgeon will be asked whether he/she considered the use of NIRF imaging an useful additive to the procedure.
measure: Histological assessment of taken biopsies: assessment Target to background ratio
time frame: biopsies taken during surgery, which are assessed during the 1th week after surgery
description: The biopsies taken during surgery will be analysed together with the video recordings. Hereby, we aim to investigate whether the different histological subtypes of endometriosis light up differently in NIRF light. We interested in whether there is another target to background rato in the different histological subtypes.
arm group label: NIRF imaging
arm group type: Experimental
description: After the white light (WL) imaging, NIRF imaging will be performed. 2.5 mg of ICG will be administered i.v. up to 5 times if needed. The lesions identified in WL, are inspected in NIRF mode. The surgeon indicated whether the lesions are more easily identified in WL or the NIRF mode and scores the visibility on a 1-10 scale. Next, inspection will take place for lesions that are seen in NIRF mode but not in WL. Biopsies will be taken from the lesions and from normal tissue for reference and sent for histology. Evaluation will take place whether the lesions differ in histological characteristics
intervention type: Device
intervention name: NIRF imaging
description: By using a fluorescence imaging device (with an adapted light source and camera), a fluorescent dye can be made visible. By injecting the fluorescent dye intravenously, the vascularization will be visible. Thereby, structures with altered vascularization are expected to 'light up' differently than the surrounding.
arm group label: NIRF imaging
other name: Near infrared fluorescence imaging
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Laurents Stassen, M.D, Ph.D
role: Principal Investigator
affiliation: Maastricht University Medical Center
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Endometriosis
sharing ipd: Undecided