<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/NCT01734746</url>
  </required_header>
  <id_info>
    <org_study_id>NL40323.068.12</org_study_id>
    <nct_id>NCT01734746</nct_id>
  </id_info>
  <brief_title>Sentinel Node Detection in Clinical Early Stage Ovarian Cancer</brief_title>
  <acronym>SONAR</acronym>
  <official_title>Sentinel Node Detection in Clinical Early Stage Ovarian Cancer</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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      As most cancers, ovarian cancer also spreads to regional lymph nodes. The concept of sentinel&#xD;
      lymph node surgery is to see whether the cancer has spread to the very first lymph node or&#xD;
      sentinel node (SN). If the sentinel node does not contain cancer, there is a high likelihood&#xD;
      that the cancer has not spread to other lymph nodes. This means that, at least theoretically,&#xD;
      a radical lymphadenectomy could be omitted and thus the associated morbidity. The sentinel&#xD;
      node technique has been proven to be effective in different cancers such as breast cancer and&#xD;
      malignant melanoma. In gynaecological tumors it has been shown to be effective in vulvar&#xD;
      cancer. Currently sentinel node studies are done for cervix and uterine cancer.&#xD;
&#xD;
      The present study determines whether or not a sentinel node procedure in patients with&#xD;
      ovarian cancer is feasible when the tracers are injected in the ovarian ligaments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to the International Federation of Gynecology and Obstetrics (FIGO), Epithelial&#xD;
      Ovarian Cancer (EOC) with lymph node metastases is classified as FIGO stage IIIC disease,&#xD;
      even in the absence of peritoneal metastases. In contrast to patients with FIGO stage I&#xD;
      ovarian cancer after a comprehensive staging procedure, patients with a FIGO stage III&#xD;
      ovarian cancer obtain adjuvant chemotherapy. Therefore, the recognition of lymph node&#xD;
      metastases is of utmost importance. In general, the incidence of lymph node metastases in&#xD;
      clinical early stage EOC is approximately 14%, and depends on subtype histology (i.e. serous&#xD;
      23%, mucinous 3%) and differentiation grade (4% and 20% in grade 1 and 3 tumors&#xD;
      respectively).&#xD;
&#xD;
      Surgical staging of EOC and the extent of lymph node dissection differs greatly from centre&#xD;
      to centre. In case of a clinical early stage ovarian cancer, the Dutch guideline recommends a&#xD;
      staging laparotomy with adequate lymph node sampling, with an absolute minimum of ten lymph&#xD;
      nodes removed. In the same guideline, a footnote is made stating that a larger number of&#xD;
      removed lymph nodes will increase the chance of finding metastases. These lymph nodes also&#xD;
      need to be sampled from different anatomical regions, of which the most important are the&#xD;
      para-aortic and paracaval region between the renal vein and inferior mesenteric artery, the&#xD;
      common, internal and external iliac vessels and the obturator fossa.&#xD;
&#xD;
      A systematic lymphadenectomy can be seen as the golden standard. However, such a radical&#xD;
      procedure gives more late morbidity than lymph node sampling. These include the formation of&#xD;
      lymphocyst (up to 13.5%), nerve and vessel injury (up to 4%), and increased blood loss and&#xD;
      operating time [26, 27]. Studies done for sentinel node in ovarian cancer are very limited&#xD;
      and performed in women with uterine cancer by injecting the tracers in the ovary. In case of&#xD;
      ovarian cancer such a procedure gives a possible risk of tumour dissemination. In this&#xD;
      feasibility study the tracers are injected in the ligaments of the ovary, not in the cortex&#xD;
      itself.&#xD;
&#xD;
      Patients with (suspicion of) ovarian cancer as well as patients with a high-grade uterine&#xD;
      carcinoma will be included. The latter group of patients can also be included because these&#xD;
      patients undergo the same surgical procedure; Total Abdominal Hysterectomy (TAH) with&#xD;
      Bilateral Salpingo-Oophorectomy (BSO) and a pelvic and para-aortic lymphadenectomy or lymph&#xD;
      node sampling.&#xD;
&#xD;
      Both blue dye and the radioactive isotope will be injected in the ligamentum ovarii proprium&#xD;
      (median side) and the ligamentum infundibulo-pelvicum (lateral side), close to the ovary and&#xD;
      just below the peritoneum.&#xD;
&#xD;
      In case of an ovarian tumor: after 15 minutes time-interval the ovarian mass will be removed&#xD;
      and presented to the pathologist for a frozen section. If the result is benign, no further&#xD;
      actions will be performed in these patients. If the result is malignant, the sentinel node(s)&#xD;
      will be identified either by the radioactive tracer and / or visually (blue dye) after&#xD;
      opening the retroperitoneal space. After removal of the sentinel node(s) a complete standard&#xD;
      staging procedure will be performed including a comprehensive sampling of other lymph nodes&#xD;
      at the different locations.&#xD;
&#xD;
      In case of endometrial cancer: after 15 minutes time-interval the surgical staging procedure&#xD;
      starts with a TAH and BSO. After approximately 45 minutes the sentinel node(s) will be&#xD;
      identified either by the radioactive tracer and / or visually (blue dye) after opening the&#xD;
      retroperitoneal space. This 45 minutes time-interval is chosen to mimic the time interval&#xD;
      when a frozen section is performed in case of an ovarian tumor. After removal of the sentinel&#xD;
      node(s) a complete standard staging procedure will be performed including a comprehensive at&#xD;
      random sampling of other lymph nodes at the different locations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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 Patients (%) in Which Sentinel Node(s) Are Detected After Injection of Blue Dye and Tracer in the Ovarian Ligaments.</measure>
    <time_frame>During surgery.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anatomical Location(s) of the Sentinel Nodes.</measure>
    <time_frame>During surgery.</time_frame>
    <description>The number of patients with only paraaortic/paracaval, only pelvic, and both paraaortic/paracaval and pelvic sentinel node locations.patients.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Patients With False Negative Sentinel Nodes.</measure>
    <time_frame>During surgery.</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Ovarian Cancer</condition>
  <condition>Sentinel Node</condition>
  <arm_group>
    <arm_group_label>Tracerinjection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention concerns tracerinjection (both blue dye and the radioactive isotope beingtechnetium-99-m-labeled albumin nanocolloid) in the ligamentum ovarii proprium (median side) and the ligamentum infundibulo-pelvicum (lateral side), close to the ovary and just below the peritoneum.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Tracerinjection</intervention_name>
    <description>The intervention concerns the tracerinjection for detection of the sentinel node.</description>
    <arm_group_label>Tracerinjection</arm_group_label>
    <other_name>99mTc-nanocolloid or Nanocoll</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a high suspicion of a malignant ovarian tumour planned for exploratory&#xD;
             laparotomy.&#xD;
&#xD;
          -  Patients with high-risk endometrial cancer in whom a staging laparotomy is planned.&#xD;
&#xD;
          -  Age between 18 and 85 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous surgery of both ovaries.&#xD;
&#xD;
          -  Previous vascular surgery of the aorta, caval vein, and/or iliac vessels.&#xD;
&#xD;
          -  Previous lymphadenectomy of lymph node sampling in the iliac or para-aortal region.&#xD;
&#xD;
          -  History of a malignant lymphoma.&#xD;
&#xD;
          -  History of a malignant tumour in the abdominal cavity.&#xD;
&#xD;
          -  Previous allergic reaction to blue dye.&#xD;
&#xD;
          -  Pregnant or lactating patients.&#xD;
&#xD;
          -  An allergy for human albumin.&#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>Roy Kruitwagen, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Maastricht UMC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MaastrichtUMC</name>
      <address>
        <city>Maastricht</city>
        <state>Limburg</state>
        <zip>6202 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <results_first_submitted>July 29, 2015</results_first_submitted>
  <results_first_submitted_qc>April 4, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">November 5, 2018</results_first_posted>
  <last_update_submitted>April 4, 2018</last_update_submitted>
  <last_update_submitted_qc>April 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ovarian cancer</keyword>
  <keyword>sentinel node</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 28, 2013</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/46/NCT01734746/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Sentinel Node Procedure</title>
          <description>Injection of both blue dye and the radioactive isotope (technetium-99-m-labeled albumin nanocolloid) in the ligamentum ovarii proprium (median side) and the ligamentum infundibulo-pelvicum (lateral side), close to the ovary and just below the peritoneum.&#xD;
blue dye and radioactive tracer</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Sentinel Node Procedure</title>
          <description>Injection of both blue dye and the radioactive isotope (technetium-99-m-labeled albumin nanocolloid) in the ligamentum ovarii proprium (median side) and the ligamentum infundibulo-pelvicum (lateral side), close to the ovary and just below the peritoneum.&#xD;
blue dye and radioactive tracer</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="22"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Age (categorical) of participants at the time of surgery.;</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <description>Ages (continuous) of participants at the time of surgery.</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.6" lower_limit="22" upper_limit="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Netherlands</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients (%) in Which Sentinel Node(s) Are Detected After Injection of Blue Dye and Tracer in the Ovarian Ligaments.</title>
        <time_frame>During surgery.</time_frame>
        <population>see Kleppe et al., J Nucl Med 2014; 55:1799-1804</population>
        <group_list>
          <group group_id="O1">
            <title>Sentinel Node Procedure</title>
            <description>Injection of both blue dye and the radioactive isotope (technetium-99-m-labeled albumin nanocolloid) in the ligamentum ovarii proprium (median side) and the ligamentum infundibulo-pelvicum (lateral side), close to the ovary and just below the peritoneum.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients (%) in Which Sentinel Node(s) Are Detected After Injection of Blue Dye and Tracer in the Ovarian Ligaments.</title>
          <population>see Kleppe et al., J Nucl Med 2014; 55:1799-1804</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anatomical Location(s) of the Sentinel Nodes.</title>
        <description>The number of patients with only paraaortic/paracaval, only pelvic, and both paraaortic/paracaval and pelvic sentinel node locations.patients.</description>
        <time_frame>During surgery.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sentinel Node Procedure</title>
            <description>Injection of both blue dye and the radioactive isotope (technetium-99-m-labeled albumin nanocolloid) in the ligamentum ovarii proprium (median side) and the ligamentum infundibulo-pelvicum (lateral side), close to the ovary and just below the peritoneum.</description>
          </group>
        </group_list>
        <measure>
          <title>Anatomical Location(s) of the Sentinel Nodes.</title>
          <description>The number of patients with only paraaortic/paracaval, only pelvic, and both paraaortic/paracaval and pelvic sentinel node locations.patients.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SN only paraaortic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SN only pelvic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SN both paraortic and pelvic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Patients With False Negative Sentinel Nodes.</title>
        <time_frame>During surgery.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sentinel Node Procedure</title>
            <description>Injection of both blue dye and the radioactive isotope (technetium-99-m-labeled albumin nanocolloid) in the ligamentum ovarii proprium (median side) and the ligamentum infundibulo-pelvicum (lateral side), close to the ovary and just below the peritoneum.&#xD;
blue dye and radioactive tracer</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With False Negative Sentinel Nodes.</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Sentinel Node Procedure</title>
          <description>Injection of both blue dye and the radioactive isotope (technetium-99-m-labeled albumin nanocolloid) in the ligamentum ovarii proprium (median side) and the ligamentum infundibulo-pelvicum (lateral side), close to the ovary and just below the peritoneum.&#xD;
blue dye and radioactive tracer</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>R.F.P.M. Kruitwagen</name_or_title>
      <organization>MaastrichtUMC</organization>
      <phone>+31433874767</phone>
      <email>r.kruitwagen@mumc.nl</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01734746
org study id: NL40323.068.12
nct id: NCT01734746
lead sponsor: 
has dmc: No
As most cancers, ovarian cancer also spreads to regional lymph nodes. The concept of sentinel
      lymph node surgery is to see whether the cancer has spread to the very first lymph node or
      sentinel node (SN). If the sentinel node does not contain cancer, there is a high likelihood
      that the cancer has not spread to other lymph nodes. This means that, at least theoretically,
      a radical lymphadenectomy could be omitted and thus the associated morbidity. The sentinel
      node technique has been proven to be effective in different cancers such as breast cancer and
      malignant melanoma. In gynaecological tumors it has been shown to be effective in vulvar
      cancer. Currently sentinel node studies are done for cervix and uterine cancer.

      The present study determines whether or not a sentinel node procedure in patients with
      ovarian cancer is feasible when the tracers are injected in the ovarian ligaments.
According to the International Federation of Gynecology and Obstetrics (FIGO), Epithelial
      Ovarian Cancer (EOC) with lymph node metastases is classified as FIGO stage IIIC disease,
      even in the absence of peritoneal metastases. In contrast to patients with FIGO stage I
      ovarian cancer after a comprehensive staging procedure, patients with a FIGO stage III
      ovarian cancer obtain adjuvant chemotherapy. Therefore, the recognition of lymph node
      metastases is of utmost importance. In general, the incidence of lymph node metastases in
      clinical early stage EOC is approximately 14%, and depends on subtype histology (i.e. serous
      23%, mucinous 3%) and differentiation grade (4% and 20% in grade 1 and 3 tumors
      respectively).

      Surgical staging of EOC and the extent of lymph node dissection differs greatly from centre
      to centre. In case of a clinical early stage ovarian cancer, the Dutch guideline recommends a
      staging laparotomy with adequate lymph node sampling, with an absolute minimum of ten lymph
      nodes removed. In the same guideline, a footnote is made stating that a larger number of
      removed lymph nodes will increase the chance of finding metastases. These lymph nodes also
      need to be sampled from different anatomical regions, of which the most important are the
      para-aortic and paracaval region between the renal vein and inferior mesenteric artery, the
      common, internal and external iliac vessels and the obturator fossa.

      A systematic lymphadenectomy can be seen as the golden standard. However, such a radical
      procedure gives more late morbidity than lymph node sampling. These include the formation of
      lymphocyst (up to 13.5%), nerve and vessel injury (up to 4%), and increased blood loss and
      operating time [26, 27]. Studies done for sentinel node in ovarian cancer are very limited
      and performed in women with uterine cancer by injecting the tracers in the ovary. In case of
      ovarian cancer such a procedure gives a possible risk of tumour dissemination. In this
      feasibility study the tracers are injected in the ligaments of the ovary, not in the cortex
      itself.

      Patients with (suspicion of) ovarian cancer as well as patients with a high-grade uterine
      carcinoma will be included. The latter group of patients can also be included because these
      patients undergo the same surgical procedure; Total Abdominal Hysterectomy (TAH) with
      Bilateral Salpingo-Oophorectomy (BSO) and a pelvic and para-aortic lymphadenectomy or lymph
      node sampling.

      Both blue dye and the radioactive isotope will be injected in the ligamentum ovarii proprium
      (median side) and the ligamentum infundibulo-pelvicum (lateral side), close to the ovary and
      just below the peritoneum.

      In case of an ovarian tumor: after 15 minutes time-interval the ovarian mass will be removed
      and presented to the pathologist for a frozen section. If the result is benign, no further
      actions will be performed in these patients. If the result is malignant, the sentinel node(s)
      will be identified either by the radioactive tracer and / or visually (blue dye) after
      opening the retroperitoneal space. After removal of the sentinel node(s) a complete standard
      staging procedure will be performed including a comprehensive sampling of other lymph nodes
      at the different locations.

      In case of endometrial cancer: after 15 minutes time-interval the surgical staging procedure
      starts with a TAH and BSO. After approximately 45 minutes the sentinel node(s) will be
      identified either by the radioactive tracer and / or visually (blue dye) after opening the
      retroperitoneal space. This 45 minutes time-interval is chosen to mimic the time interval
      when a frozen section is performed in case of an ovarian tumor. After removal of the sentinel
      node(s) a complete standard staging procedure will be performed including a comprehensive at
      random sampling of other lymph nodes at the different locations.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of Patients (%) in Which Sentinel Node(s) Are Detected After Injection of Blue Dye and Tracer in the Ovarian Ligaments.
time frame: During surgery.
measure: Anatomical Location(s) of the Sentinel Nodes.
time frame: During surgery.
description: The number of patients with only paraaortic/paracaval, only pelvic, and both paraaortic/paracaval and pelvic sentinel node locations.patients.
measure: Number of Patients With False Negative Sentinel Nodes.
time frame: During surgery.
arm group label: Tracerinjection
arm group type: Experimental
description: The intervention concerns tracerinjection (both blue dye and the radioactive isotope beingtechnetium-99-m-labeled albumin nanocolloid) in the ligamentum ovarii proprium (median side) and the ligamentum infundibulo-pelvicum (lateral side), close to the ovary and just below the peritoneum.
intervention type: Procedure
intervention name: Tracerinjection
description: The intervention concerns the tracerinjection for detection of the sentinel node.
arm group label: Tracerinjection
other name: 99mTc-nanocolloid or Nanocoll
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roy Kruitwagen, MD, PhD
role: Study Director
affiliation: Maastricht UMC
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 