<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/NCT02221076</url>
  </required_header>
  <id_info>
    <org_study_id>GYN_MKT_2014</org_study_id>
    <secondary_id>2014-A00312-45</secondary_id>
    <nct_id>NCT02221076</nct_id>
  </id_info>
  <brief_title>Probe-based and Needle-based Confocal Laser Endomicroscopy During Gynaecological Procedures.</brief_title>
  <official_title>Probe-based and Needle-based Confocal Laser Endomicroscopy During Gynaecological Examinations or Surgical Procedures for Gynecological Cancers : a Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mauna Kea Technologies</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mauna Kea Technologies</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The protocol aims at demonstrating the technical feasibility and safety of doing&#xD;
      endomicroscopic imaging (both probe-based confocal laser endomicroscopy (pCLE) and&#xD;
      needle-based confocal laser endomicroscopy, nCLE) during colposcopy, hysteroscopy, and&#xD;
      surgical procedures (open surgery and laparoscopic robot assisted or not) to examine all&#xD;
      pelvic tissues including cervix, uterus, adnexia, peritoneum, normal and pathologic aspect.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective study: about 75 patients (25 for each pathology) scheduled for a&#xD;
      colposcopy or hysteroscopy examination or for a surgical treatment of the&#xD;
      cervix/endocervix/endometrium/ovarian or tubal cancer will be enrolled. They will undergo the&#xD;
      diagnostic consultation or surgical procedure, as per standard of care, plus an additional&#xD;
      pCLE/nCLE procedure with the prototype probes, which will add between 5 and 10 minutes&#xD;
      maximum to the examination.&#xD;
&#xD;
      The confocal miniprobe will be positioned against the surface of these organs or inside these&#xD;
      same organs if the tumor is intratissular through a needle, and sequences will be acquired.&#xD;
      Final diagnosis will be obtained for the patient, either through the result of the biopsies&#xD;
      or through surgical pathology if the patient's lesion is surgically resected. Then imaging&#xD;
      will be performed as well ex vivo on the resected specimens to provide additional stable&#xD;
      imaging, and compare image quality to in vivo imaging.&#xD;
&#xD;
      The clinical endpoints of the study are:&#xD;
&#xD;
        -  One or several Confocal Miniprobe designs optimized for use during colposcopy and&#xD;
           hysteroscopy&#xD;
&#xD;
        -  An optimized protocol of operations when using the designed Confocal Miniprobes during&#xD;
           colposcopy and hysteroscopy as well as in the surgical setting, robotized or not&#xD;
           (staining, use of accessories to hold the probes, etc...)&#xD;
&#xD;
        -  A first atlas of endomicroscopic images obtained in the cervix, endocervix and&#xD;
           endometrium&#xD;
&#xD;
        -  The number, type and severity of recorded adverse events (to evaluate the safety).&#xD;
&#xD;
      Final objectives of CLE in gynecology:&#xD;
&#xD;
        -  During colposcopic examination of the exocervix and conization, CLE is intended to be&#xD;
           used to target biopsy and guide resection.&#xD;
&#xD;
        -  During hysteroscopic examination of the endocervix, CLE is intended to be used to target&#xD;
           biopsy and guide resection. Its ability to diagnose endocervical cancer will be&#xD;
           evaluated.&#xD;
&#xD;
        -  For endometrium cancer, CLE is to be used to target biopsy during hysteroscopy&#xD;
           procedures and to evaluate cancer extension by examining lymphe node invasion during&#xD;
           surgical procedures.&#xD;
&#xD;
        -  During adjuvant surgery, the cervix is to be imaged by CLE to describe area altered by&#xD;
           radio-chemotherapy.&#xD;
&#xD;
        -  Ovaries and tubes are to be imaged by CLE before chemotherapy to diagnose cancer and&#xD;
           after chemotherapy to detect residual tumor or fibrosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">April 18, 2016</completion_date>
  <primary_completion_date type="Actual">April 18, 2016</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>The number of participants with adverse events, their type and severity.</measure>
    <time_frame>8 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of interpretable images per organ and per pathology</measure>
    <time_frame>8 months</time_frame>
    <description>Each sequence acquired during the cases will be annotated as to which organ it is, and the final diagnosis of the specimen (healthy, cancerous, inflammation, etc...). Thanks to this, a more complete atlas of images obtained gynaecological organs and conditions will be developed. This atlas will be used to describe image interpretation criteria for endomicroscopic images of various organs and conditions. This work will be done in conjunction by the investigators the histopathologist, and an Mauna Kea Technologies representative familiar with image interpretation in current endomicroscopy indications.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Cervix Cancer</condition>
  <condition>Endometrium Cancer</condition>
  <condition>Ovarian Cancer</condition>
  <condition>Carcinoma in Situ of Fallopian Tube</condition>
  <arm_group>
    <arm_group_label>Confocal Laser Endomicroscopy (CLE)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patient will undergo a 10 minutes endomicroscopy procedure to obtain real time microscopical images of healthy and malignant tissue of the targeted organs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Confocal Laser Endomicroscopy (CLE)</intervention_name>
    <description>Real-time microscopic imaging of living tissue during the standard procedure</description>
    <arm_group_label>Confocal Laser Endomicroscopy (CLE)</arm_group_label>
    <other_name>Optical biopsy</other_name>
    <other_name>Cellvizio</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for a colposcopy&#xD;
&#xD;
          -  Patients scheduled for a hysteroscopy&#xD;
&#xD;
          -  Patients scheduled for a surgical treatment for a suspected cervix/ endocervix/&#xD;
             endometrium lesion&#xD;
&#xD;
          -  18 years or older.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to fluorescein&#xD;
&#xD;
          -  Previous life-threatening allergic reactions and known hypersensitivity&#xD;
&#xD;
          -  Pregnancy or breast-feeding&#xD;
&#xD;
          -  History of cardio-pulmonary disease (including bronchial asthma)&#xD;
&#xD;
          -  Restricted renal function&#xD;
&#xD;
          -  Patients under a beta-blockers treatment&#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>ERIC LAMBAUDIE</last_name>
    <role>Principal Investigator</role>
    <affiliation>IPC, Marseille, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut Paoli Calmettes</name>
      <address>
        <city>Marseille</city>
        <zip>13273</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>August 28, 2017</last_update_submitted>
  <last_update_submitted_qc>August 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cellvizio</keyword>
  <keyword>Endomicroscopy</keyword>
  <keyword>Robot-assisted procedure</keyword>
  <keyword>Cervix cancer</keyword>
  <keyword>Endocervix cancer</keyword>
  <keyword>Endometrium cancer</keyword>
  <keyword>Ovarian cancer</keyword>
  <keyword>Tubal cancer</keyword>
  <keyword>Colposcopy</keyword>
  <keyword>Hysteroscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma in Situ</mesh_term>
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
    <mesh_term>Endometrial 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/NCT02221076
org study id: GYN_MKT_2014
secondary id: 2014-A00312-45
nct id: NCT02221076
lead sponsor: 
has dmc: No
The protocol aims at demonstrating the technical feasibility and safety of doing
      endomicroscopic imaging (both probe-based confocal laser endomicroscopy (pCLE) and
      needle-based confocal laser endomicroscopy, nCLE) during colposcopy, hysteroscopy, and
      surgical procedures (open surgery and laparoscopic robot assisted or not) to examine all
      pelvic tissues including cervix, uterus, adnexia, peritoneum, normal and pathologic aspect.
This is a prospective study: about 75 patients (25 for each pathology) scheduled for a
      colposcopy or hysteroscopy examination or for a surgical treatment of the
      cervix/endocervix/endometrium/ovarian or tubal cancer will be enrolled. They will undergo the
      diagnostic consultation or surgical procedure, as per standard of care, plus an additional
      pCLE/nCLE procedure with the prototype probes, which will add between 5 and 10 minutes
      maximum to the examination.

      The confocal miniprobe will be positioned against the surface of these organs or inside these
      same organs if the tumor is intratissular through a needle, and sequences will be acquired.
      Final diagnosis will be obtained for the patient, either through the result of the biopsies
      or through surgical pathology if the patient's lesion is surgically resected. Then imaging
      will be performed as well ex vivo on the resected specimens to provide additional stable
      imaging, and compare image quality to in vivo imaging.

      The clinical endpoints of the study are:

        -  One or several Confocal Miniprobe designs optimized for use during colposcopy and
           hysteroscopy

        -  An optimized protocol of operations when using the designed Confocal Miniprobes during
           colposcopy and hysteroscopy as well as in the surgical setting, robotized or not
           (staining, use of accessories to hold the probes, etc...)

        -  A first atlas of endomicroscopic images obtained in the cervix, endocervix and
           endometrium

        -  The number, type and severity of recorded adverse events (to evaluate the safety).

      Final objectives of CLE in gynecology:

        -  During colposcopic examination of the exocervix and conization, CLE is intended to be
           used to target biopsy and guide resection.

        -  During hysteroscopic examination of the endocervix, CLE is intended to be used to target
           biopsy and guide resection. Its ability to diagnose endocervical cancer will be
           evaluated.

        -  For endometrium cancer, CLE is to be used to target biopsy during hysteroscopy
           procedures and to evaluate cancer extension by examining lymphe node invasion during
           surgical procedures.

        -  During adjuvant surgery, the cervix is to be imaged by CLE to describe area altered by
           radio-chemotherapy.

        -  Ovaries and tubes are to be imaged by CLE before chemotherapy to diagnose cancer and
           after chemotherapy to detect residual tumor or fibrosis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The number of participants with adverse events, their type and severity.
time frame: 8 months
measure: Number of interpretable images per organ and per pathology
time frame: 8 months
description: Each sequence acquired during the cases will be annotated as to which organ it is, and the final diagnosis of the specimen (healthy, cancerous, inflammation, etc...). Thanks to this, a more complete atlas of images obtained gynaecological organs and conditions will be developed. This atlas will be used to describe image interpretation criteria for endomicroscopic images of various organs and conditions. This work will be done in conjunction by the investigators the histopathologist, and an Mauna Kea Technologies representative familiar with image interpretation in current endomicroscopy indications.
arm group label: Confocal Laser Endomicroscopy (CLE)
arm group type: Experimental
description: The patient will undergo a 10 minutes endomicroscopy procedure to obtain real time microscopical images of healthy and malignant tissue of the targeted organs.
intervention type: Device
intervention name: Confocal Laser Endomicroscopy (CLE)
description: Real-time microscopic imaging of living tissue during the standard procedure
arm group label: Confocal Laser Endomicroscopy (CLE)
other name: Optical biopsy
other name: Cellvizio
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: ERIC LAMBAUDIE
role: Principal Investigator
affiliation: IPC, Marseille, France
facility: 
country: France
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma in Situ
mesh term: Uterine Cervical Neoplasms
mesh term: Endometrial Neoplasms
sharing ipd: No