<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/NCT02249208</url>
  </required_header>
  <id_info>
    <org_study_id>SENTINAC-01</org_study_id>
    <nct_id>NCT02249208</nct_id>
  </id_info>
  <brief_title>Sentinel Lymph Node Biopsy With Superparamagnetic Iron Oxide for Breast Cancer Patients After Neoadjuvant Treatment.</brief_title>
  <acronym>SENTINAC-01</acronym>
  <official_title>Sentinel Lymph Node Biopsy With Superparamagnetic Iron Oxide vs. Standard Technique After Neoadjuvant Chemotherapy in Patients With Node-Positive Breast Cancer. A Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitari Vall d'Hebron Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sysmex España S.L.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Universitari Vall d'Hebron Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the detection rate and the false negative rate of&#xD;
      sentinel lymph node (SLN) by superparamagnetic iron oxide (SPIO) alone or in addition to&#xD;
      radioisotope and compared to the standard method (blue and radioisotope) after neoadjuvant&#xD;
      chemotherapy in patients with node-positive breast cancer converted to node negative after&#xD;
      treatment by ultrasound. A randomized controlled trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Identification of Sentinel node:&#xD;
&#xD;
        -  Arm 1 (Tc+blue dye): Identification of SLN using the standard technique of sub-areolar&#xD;
           injection of technetium-99m (Tc-99m) and vital blue dye before surgery.&#xD;
&#xD;
        -  Arm 2 (Tc+SPIO): Identification of SLN using standard isotope technique of sub-areolar&#xD;
           injection of technetium-99m (Tc-99m) before surgery and the magnetic technique with the&#xD;
           sub-areolar injection of SPIO (Sienna+®) before surgery and detection with the SentiMag®&#xD;
           probe. (Study)&#xD;
&#xD;
        -  Arm 3 (SPIO alone): Identification of SLN using the magnetic technique with the&#xD;
           sub-areolar injection of SPIO (Sienna+®) before surgery and detection with the SentiMag®&#xD;
           probe. (Study)&#xD;
&#xD;
      Sentinel node's excision of radioactive and / or blue and / or magnetic (colored&#xD;
      brown-brown), detection guided by hand probe gamma radiation, colorimetric and / or and&#xD;
      SentiMag® paramagnetic probe.&#xD;
&#xD;
      Lymph nodes that are radioactive, blue, magnetic or palpable are considered SLNs and are&#xD;
      resected and submitted for pathological analysis. The protocol required that at least 2 SLNs&#xD;
      to be resected.&#xD;
&#xD;
      In all cases a completion axillary lymphadenectomy nodes dissection (ALND) will be performed&#xD;
      after SLN biopsy. All SLNs will be excised and submitted before performing the ALND.&#xD;
&#xD;
      Characterization of the nodal status of patients with the detection rate and the false&#xD;
      negative rate of SLN for each arm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2014</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">June 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>False Negative Rate</measure>
    <time_frame>3 months</time_frame>
    <description>The proportion of number of patients with a negative SLN biopsy with the number of patients with axillary lymph node metastases.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Detection Rate</measure>
    <time_frame>3 months</time_frame>
    <description>The Proportion of patients that SLNs was identified compared to total ALND patients.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Tc+blue dye</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sentinel Lymph Node (SLN) identification and resection using the standard technique of sub-areolar injection of technetium-99m (Tc-99m) and sub-areolar injection of vital blue dye before surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tc+SPIO</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sentinel Lymph Node (SLN) identification and resection using isotope technique of sub-areolar injection of technetium-99m (Tc-99m) and the magnetic technique with the sub-areolar injection of SPIO (Sienna+®), before surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SPIO alone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sentinel Lymph Node (SLN) identification and resection using the magnetic technique with the sub-areolar injection of SPIO (Sienna+®) before surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tc+blue dye</intervention_name>
    <description>Sentinel Lymph Node (SLN) identification and resection using the standard technique of sub-areolar injection of technetium-99m (Tc-99m) and sub-areolar injection of vital blue dye before surgery</description>
    <arm_group_label>Tc+blue dye</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tc+SPIO</intervention_name>
    <description>Sentinel Lymph Node (SLN) identification and resection using isotope technique of sub-areolar injection of technetium-99m (Tc-99m) and the magnetic technique with the sub-areolar injection of SPIO (Sienna+®), before surgery</description>
    <arm_group_label>Tc+SPIO</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SPIO alone</intervention_name>
    <description>Sentinel Lymph Node (SLN) identification and resection using the magnetic technique with the sub-areolar injection of SPIO (Sienna+®) before surgery</description>
    <arm_group_label>SPIO alone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven primary invasive breast cancer with clinical stage T1 through&#xD;
             T3, N1 through N2, M0 according to the American Joint Committee on Cancer (AJCC)&#xD;
             Cancer Staging Manual, seventh edition&#xD;
&#xD;
          -  Completed or were planning to undergo neoadjuvant chemotherapy&#xD;
&#xD;
          -  Prechemotherapy axillary nodal disease confirmed by fine-needle aspiration or&#xD;
             core-needle biopsy&#xD;
&#xD;
          -  The axilla is clinically and radiologically (by ultrasound) negative (ycN0)&#xD;
             postchemotherapy and before surgery&#xD;
&#xD;
          -  Removal of at least two SLNs&#xD;
&#xD;
          -  Signed informed consent from each patient before study entry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  T4 tumors, cN3 or cM1&#xD;
&#xD;
          -  The axilla is clinically and radiologically (by ultrasound) positive (ycN1)&#xD;
             postchemotherapy&#xD;
&#xD;
          -  Intolerance or hypersensitivity to the compounds or iron dextran or superparamagnetic&#xD;
             iron oxide or to vital blue dye or radioactive product.&#xD;
&#xD;
          -  Chronic iron overload&#xD;
&#xD;
          -  Pacemaker or other metallic implantable device in the chest wall&#xD;
&#xD;
          -  Failure to submit to medical study for geographical, social or psychological&#xD;
&#xD;
          -  Patient deprived of liberty or under guardianship&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Isabel T Rubio, MD. PhD.</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Universitario Vall D Hebron. Universidad Autónoma de Barcelona.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Isabel T Rubio, MD. PhD.</last_name>
    <email>irubio@vhio.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Universitario Vall D Hebron.</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Isabel T Rubio, MD. PhD.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Martin Espinosa-Bravo, MD. PhD.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 29, 2014</last_update_submitted>
  <last_update_submitted_qc>September 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 30, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <keyword>Sentinel Lymph Node</keyword>
  <keyword>Neoadjuvant Chemotherapy</keyword>
  <keyword>Clinically Node-Positive with biopsy-proven cN1</keyword>
  <keyword>False-negative Rate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast 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/NCT02249208
org study id: SENTINAC-01
nct id: NCT02249208
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine the detection rate and the false negative rate of
      sentinel lymph node (SLN) by superparamagnetic iron oxide (SPIO) alone or in addition to
      radioisotope and compared to the standard method (blue and radioisotope) after neoadjuvant
      chemotherapy in patients with node-positive breast cancer converted to node negative after
      treatment by ultrasound. A randomized controlled trial.
Identification of Sentinel node:

        -  Arm 1 (Tc+blue dye): Identification of SLN using the standard technique of sub-areolar
           injection of technetium-99m (Tc-99m) and vital blue dye before surgery.

        -  Arm 2 (Tc+SPIO): Identification of SLN using standard isotope technique of sub-areolar
           injection of technetium-99m (Tc-99m) before surgery and the magnetic technique with the
           sub-areolar injection of SPIO (Sienna+®) before surgery and detection with the SentiMag®
           probe. (Study)

        -  Arm 3 (SPIO alone): Identification of SLN using the magnetic technique with the
           sub-areolar injection of SPIO (Sienna+®) before surgery and detection with the SentiMag®
           probe. (Study)

      Sentinel node's excision of radioactive and / or blue and / or magnetic (colored
      brown-brown), detection guided by hand probe gamma radiation, colorimetric and / or and
      SentiMag® paramagnetic probe.

      Lymph nodes that are radioactive, blue, magnetic or palpable are considered SLNs and are
      resected and submitted for pathological analysis. The protocol required that at least 2 SLNs
      to be resected.

      In all cases a completion axillary lymphadenectomy nodes dissection (ALND) will be performed
      after SLN biopsy. All SLNs will be excised and submitted before performing the ALND.

      Characterization of the nodal status of patients with the detection rate and the false
      negative rate of SLN for each arm.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: False Negative Rate
time frame: 3 months
description: The proportion of number of patients with a negative SLN biopsy with the number of patients with axillary lymph node metastases.
measure: Detection Rate
time frame: 3 months
description: The Proportion of patients that SLNs was identified compared to total ALND patients.
arm group label: Tc+blue dye
arm group type: Active Comparator
description: Sentinel Lymph Node (SLN) identification and resection using the standard technique of sub-areolar injection of technetium-99m (Tc-99m) and sub-areolar injection of vital blue dye before surgery.
arm group label: Tc+SPIO
arm group type: Experimental
description: Sentinel Lymph Node (SLN) identification and resection using isotope technique of sub-areolar injection of technetium-99m (Tc-99m) and the magnetic technique with the sub-areolar injection of SPIO (Sienna+®), before surgery.
arm group label: SPIO alone
arm group type: Experimental
description: Sentinel Lymph Node (SLN) identification and resection using the magnetic technique with the sub-areolar injection of SPIO (Sienna+®) before surgery.
intervention type: Device
intervention name: Tc+blue dye
description: Sentinel Lymph Node (SLN) identification and resection using the standard technique of sub-areolar injection of technetium-99m (Tc-99m) and sub-areolar injection of vital blue dye before surgery
arm group label: Tc+blue dye
intervention type: Device
intervention name: Tc+SPIO
description: Sentinel Lymph Node (SLN) identification and resection using isotope technique of sub-areolar injection of technetium-99m (Tc-99m) and the magnetic technique with the sub-areolar injection of SPIO (Sienna+®), before surgery
arm group label: Tc+SPIO
intervention type: Device
intervention name: SPIO alone
description: Sentinel Lymph Node (SLN) identification and resection using the magnetic technique with the sub-areolar injection of SPIO (Sienna+®) before surgery
arm group label: SPIO alone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Isabel T Rubio, MD. PhD.
role: Study Director
affiliation: Hospital Universitario Vall D Hebron. Universidad Autónoma de Barcelona.
last name: Isabel T Rubio, MD. PhD.
email: irubio@vhio.net
facility: 
status: Recruiting
investigator: 
investigator: 
country: Spain
responsible party type: Sponsor
mesh term: Breast Neoplasms