<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/NCT04492995</url>
  </required_header>
  <id_info>
    <org_study_id>HYBRID-ENDONODE</org_study_id>
    <secondary_id>2020-001970-31</secondary_id>
    <nct_id>NCT04492995</nct_id>
  </id_info>
  <brief_title>Sentinel Node in Endometrial Cancer</brief_title>
  <acronym>HYBRIDENDONOD</acronym>
  <official_title>Sentinel Node in Endometrial Cancer by Detection of Hybrid ([99mTc] Tc-albumin Nanocoloid-ICG). A Comparative Pilot Study Between the Lymphatic Map Derived From the Cervical Puncture Versus Myometrial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Judit Pich Martínez</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundacion Clinic per a la Recerca Biomédica</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Phase II, open-label, randomized pilot study.&#xD;
&#xD;
      Patients will be randomized (1:1) to receive for sentinel node screening:&#xD;
&#xD;
        1. Radiotracer (RT) via cervical administration and TUMIR&#xD;
&#xD;
        2. Combination of RT with Indocyanine Green (RT + ICG) via cervical administration and&#xD;
           TUMIR Patients will be followed up to 1 month after the last administration of&#xD;
           radiotracer 70 patients will be included into the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 5, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients with intraoperative detection of sentinel nodes</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of sentinel nodes biopsied during surgery after injection of the [99mTc] hybrid radiotracer Tc-albumin nanocoloid-ICG (hybrid RT) or albumin nanocoloid (RT) radiotracer [99mTc] by myometrial injection guided by transvaginal ultrasound (TUMIR).</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of sentinel lymph nodes with lymph node infiltration detected during surgery after injection of hybrid RT or RT by guided myometrial injection by transvaginal ultrasound (TUMIR)</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of lymph nodes with lymph node infiltration detected in the piece of lymphadenectomy after injection of hybrid RT or RT by TUMIR injection lymphadenectomy after injection of hybrid RT or RT by TUMIR injection</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of false negative results after injection of the hybrid RT or RT by transvaginal ultrasound-guided myometrial injection (TUMIR).</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the number of sentinel nodes visualized after injection of the hybrid RT or RT between TUMIR lymphogammagraphy and cervical lymphogammagraphy</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the drainage pattern of each radiotracer (hybrid RT and RT) between the cervical injection and transvaginal ultrasound-guided myometrial injection (TUMIR).</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Causes of non-drainage of the hybrid RT or RT in the cervical injection or in the Transvaginal ultrasound-guided myometrial injection (TUMIR).</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between the proportion of paraortic sentinel nodes detected after injection of each of the radiotracers (hybrid RT and RT) during surgery.</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with hypersensitivity reactions related to injection of each of the two radiotracers (hybrid RT and RT).</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with adverse events related to injection of one of the two radiotracers (hybrid RT and RT).</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical detection time of sentinel nodes during intraoperative detection after injection of each of the two radiotracers (hybrid RT and RT).</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Histological data of the tumor: histology, tumor grade, tumor size and myometrial infiltration.</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Endometrial Cancer</condition>
  <arm_group>
    <arm_group_label>Radiotracer + TUMIR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TUMIR = transvaginal ultrsound-guided myometrial injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>(Radiotraces + ICG) + TUMIR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ICG =indocyanine green TUMIR = transvaginal ultrsound-guided myometrial injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>injection via TUMIR of the tracer [99mTc] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml)</intervention_name>
    <description>The day before the surgery, a new scan (planar and SPECT / CT) will be performed after the injection via TUMIR of the tracer [99mTc] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml) or the injection via TUMIR of [99mTc] Tc-albumin nanocoloid (6mCi, 8ml).&#xD;
The two lymphatic maps will be compared and the number of sentinel nodes identified in each study and the territories of drainage and the difference between them (in number and territories) will be established.&#xD;
On the day of surgery, a cervical injection of methylene blue will be performed at the start of surgery according to usual methodology (2 ml diluted to 50%). Intraoperative detection of the sentinel nodes will take place by visual inspection, using the gammadetector probe and NIR optics. Sentinel node biopsies will be processed according to the usual processing methodology and analysis for the detection of metastases.</description>
    <arm_group_label>Radiotracer + TUMIR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>injection via TUMIR of [99mTc] Tc-albumin nanocoloid (6mCi, 8ml).</intervention_name>
    <description>The day before the surgery, a new scan (planar and SPECT / CT) will be performed after the injection via TUMIR of the tracer [99mTc] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml) or the injection via TUMIR of [99mTc] Tc-albumin nanocoloid (6mCi, 8ml).&#xD;
The two lymphatic maps will be compared and the number of sentinel nodes identified in each study and the territories of drainage and the difference between them (in number and territories) will be established.&#xD;
On the day of surgery, a cervical injection of methylene blue will be performed at the start of surgery according to usual methodology (2 ml diluted to 50%). Intraoperative detection of the sentinel nodes will take place by visual inspection, using the gammadetector probe and NIR optics. Sentinel node biopsies will be processed according to the usual processing methodology and analysis for the detection of metastases.</description>
    <arm_group_label>(Radiotraces + ICG) + TUMIR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years.&#xD;
&#xD;
          2. Histological diagnosis of endometrial cancer with criteria of high risk according to&#xD;
             the following criteria: - unfavorable histology according to FIGO (adenocarcinoma&#xD;
             serous, clear cell, or carcinosarcoma) - nuclear grade 3 - suspected myometrial&#xD;
             invasion&gt; 50% by resonance magnetic (MR) or transvaginal ultrasound&#xD;
&#xD;
          3. Women of childbearing age should have a transvaginal ultrasound who rule out pregnancy&#xD;
             and must commit to using methods highly effective contraceptives (vasectomized couple&#xD;
             and sexual abstinence) until the hysterectomy is performed.&#xD;
&#xD;
          4. Patient who gives written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy or lactation.&#xD;
&#xD;
          2. Suspected lymph node or distant metastatic disease in the preoperative study.&#xD;
&#xD;
          3. History of previous surgery or radiotherapy in the pelvic and paraortic lymphatic&#xD;
             drainage areas or nodal involvement of any other etiology.&#xD;
&#xD;
          4. Body mass index (BMI) greater than 45 Kg / m2.&#xD;
&#xD;
          5. Patients who, in the researcher's opinion, are not suitable for participate,&#xD;
             regardless of reason, including medical or clinical, or participants potentially at&#xD;
             risk of not comply with the study procedures.&#xD;
&#xD;
          6. Known hypersensitivity to some of the active substances or excipients from RT or ICG&#xD;
             (including previous history of hypersensitivity to products containing human albumin).&#xD;
&#xD;
          7. Hypersensitivity to sodium iodide.&#xD;
&#xD;
          8. Patients allergic to iodine.&#xD;
&#xD;
          9. Patients with clinical hyperthyroidism, thyroid adenomas autonomic and diffuse focal&#xD;
             and autonomic disturbances of the gland thyroid.&#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>Pilar Paredes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clinic of Barcelona</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sergi Vidal</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clinic of Barcelona</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pilar Paredes, MD</last_name>
    <phone>+34932275400</phone>
    <email>pparedes@clinic.cat</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sergi Vidal</last_name>
    <phone>+34932275400</phone>
    <email>svidal@clinic.cat</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital Clínic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pilar Paredes, MD</last_name>
    </contact>
    <investigator>
      <last_name>Pilar Paredes, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sergi Vidal</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>September 15, 2023</last_update_submitted>
  <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Fundacion Clinic per a la Recerca Biomédica</investigator_affiliation>
    <investigator_full_name>Judit Pich Martínez</investigator_full_name>
    <investigator_title>Clinical Research Manager</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometrial Neoplasms</mesh_term>
  </condition_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/NCT04492995
org study id: HYBRID-ENDONODE
secondary id: 2020-001970-31
nct id: NCT04492995
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Phase II, open-label, randomized pilot study.

      Patients will be randomized (1:1) to receive for sentinel node screening:

        1. Radiotracer (RT) via cervical administration and TUMIR

        2. Combination of RT with Indocyanine Green (RT + ICG) via cervical administration and
           TUMIR Patients will be followed up to 1 month after the last administration of
           radiotracer 70 patients will be included into the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Proportion of patients with intraoperative detection of sentinel nodes
time frame: 1 month
measure: Number of sentinel nodes biopsied during surgery after injection of the [99mTc] hybrid radiotracer Tc-albumin nanocoloid-ICG (hybrid RT) or albumin nanocoloid (RT) radiotracer [99mTc] by myometrial injection guided by transvaginal ultrasound (TUMIR).
time frame: 1 month
measure: Number of sentinel lymph nodes with lymph node infiltration detected during surgery after injection of hybrid RT or RT by guided myometrial injection by transvaginal ultrasound (TUMIR)
time frame: 1 month
measure: Number of lymph nodes with lymph node infiltration detected in the piece of lymphadenectomy after injection of hybrid RT or RT by TUMIR injection lymphadenectomy after injection of hybrid RT or RT by TUMIR injection
time frame: 1 month
measure: Number of false negative results after injection of the hybrid RT or RT by transvaginal ultrasound-guided myometrial injection (TUMIR).
time frame: 1 month
measure: Difference in the number of sentinel nodes visualized after injection of the hybrid RT or RT between TUMIR lymphogammagraphy and cervical lymphogammagraphy
time frame: 1 month
measure: Difference in the drainage pattern of each radiotracer (hybrid RT and RT) between the cervical injection and transvaginal ultrasound-guided myometrial injection (TUMIR).
time frame: 1 month
measure: Causes of non-drainage of the hybrid RT or RT in the cervical injection or in the Transvaginal ultrasound-guided myometrial injection (TUMIR).
time frame: 1 month
measure: Difference between the proportion of paraortic sentinel nodes detected after injection of each of the radiotracers (hybrid RT and RT) during surgery.
time frame: 1 month
measure: Proportion of patients with hypersensitivity reactions related to injection of each of the two radiotracers (hybrid RT and RT).
time frame: 1 month
measure: Proportion of patients with adverse events related to injection of one of the two radiotracers (hybrid RT and RT).
time frame: 1 month
measure: Surgical detection time of sentinel nodes during intraoperative detection after injection of each of the two radiotracers (hybrid RT and RT).
time frame: 1 month
measure: Histological data of the tumor: histology, tumor grade, tumor size and myometrial infiltration.
time frame: 1 month
arm group label: Radiotracer + TUMIR
arm group type: Active Comparator
description: TUMIR = transvaginal ultrsound-guided myometrial injection
arm group label: (Radiotraces + ICG) + TUMIR
arm group type: Experimental
description: ICG =indocyanine green TUMIR = transvaginal ultrsound-guided myometrial injection
intervention type: Diagnostic Test
intervention name: injection via TUMIR of the tracer [99mTc] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml)
description: The day before the surgery, a new scan (planar and SPECT / CT) will be performed after the injection via TUMIR of the tracer [99mTc] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml) or the injection via TUMIR of [99mTc] Tc-albumin nanocoloid (6mCi, 8ml).
The two lymphatic maps will be compared and the number of sentinel nodes identified in each study and the territories of drainage and the difference between them (in number and territories) will be established.
On the day of surgery, a cervical injection of methylene blue will be performed at the start of surgery according to usual methodology (2 ml diluted to 50%). Intraoperative detection of the sentinel nodes will take place by visual inspection, using the gammadetector probe and NIR optics. Sentinel node biopsies will be processed according to the usual processing methodology and analysis for the detection of metastases.
arm group label: Radiotracer + TUMIR
intervention type: Diagnostic Test
intervention name: injection via TUMIR of [99mTc] Tc-albumin nanocoloid (6mCi, 8ml).
description: The day before the surgery, a new scan (planar and SPECT / CT) will be performed after the injection via TUMIR of the tracer [99mTc] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml) or the injection via TUMIR of [99mTc] Tc-albumin nanocoloid (6mCi, 8ml).
The two lymphatic maps will be compared and the number of sentinel nodes identified in each study and the territories of drainage and the difference between them (in number and territories) will be established.
On the day of surgery, a cervical injection of methylene blue will be performed at the start of surgery according to usual methodology (2 ml diluted to 50%). Intraoperative detection of the sentinel nodes will take place by visual inspection, using the gammadetector probe and NIR optics. Sentinel node biopsies will be processed according to the usual processing methodology and analysis for the detection of metastases.
arm group label: (Radiotraces + ICG) + TUMIR
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pilar Paredes, MD
role: Principal Investigator
affiliation: Hospital Clinic of Barcelona
last name: Sergi Vidal
role: Principal Investigator
affiliation: Hospital Clinic of Barcelona
last name: Pilar Paredes, MD
phone: +34932275400
email: pparedes@clinic.cat
last name: Sergi Vidal
phone: +34932275400
email: svidal@clinic.cat
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Spain
responsible party type: Sponsor-Investigator
investigator affiliation: Fundacion Clinic per a la Recerca Biomédica
investigator full name: Judit Pich Martínez
investigator title: Clinical Research Manager
mesh term: Endometrial Neoplasms