<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/NCT03036475</url>
  </required_header>
  <id_info>
    <org_study_id>107-15</org_study_id>
    <nct_id>NCT03036475</nct_id>
  </id_info>
  <brief_title>Sienna and Sentimag in Sentinel Lymph Node Biopsy</brief_title>
  <acronym>Sienna</acronym>
  <official_title>Sentinel Lymph Node Biopsy Using a Magnetic Tracer Versus Standard Radio-isotope Technique in Early Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yolanda Chan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kwong Wah Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate a new method for the localization of breast cancer&#xD;
      sentinel lymph node using Sienna+® and Sentimag® detection in comparison to our standard&#xD;
      techniques with radio-isotopes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The use of radioisotope with or without blue dye has long become the gold standard for&#xD;
      sentinel lymph node localization in the management of breast cancer. The latest evidence from&#xD;
      a number of European trials has proven that a new tracer agent, superparamagnetic iron oxide&#xD;
      particles (SPIOs, Sienna+®), is non-inferior to the standard method of lymphatic mapping. Its&#xD;
      application and feasibility has yet been tried in most Asian countries.&#xD;
&#xD;
      This is a prospective paired comparison trial involving both the new magnetic technique and&#xD;
      the standard method. Patients with preoperative diagnosis of invasive carcinoma or ductal&#xD;
      carcinoma in-situ of the breast undergoing SNOLL (Sentinel node and occult lesion&#xD;
      localization) will be recruited from the Breast Centre of Kwong Wah Hospital. Informed&#xD;
      consent will be obtained. All patients recruited will receive subcutaneous injection of 2 ml&#xD;
      of Sienna+® diluted with saline to 5 ml at Breast Centre in the morning of operation,&#xD;
      followed by five minutes of massage to the injection site. Before incision, on-table&#xD;
      transcutaneous detection with the handheld magnetometer are carried out after at least 20&#xD;
      minutes from injection. Intraoperative counts of sentinel lymph nodes identified as well as&#xD;
      the ex-vivo counts of excised nodes are also measured. All procedures are supplemented with&#xD;
      localization by radioisotope. All lymph nodes excised will be sent for histopathological&#xD;
      examination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2018</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>Proportion of successful procedures for sentinel lymph node identification (identification rate per patient) by the magnetic method compared with the standard method</measure>
    <time_frame>Two years</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">52</enrollment>
  <condition>Breast Cancer</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sienna+ injection</intervention_name>
    <description>Subcutaneous injection of Sienna+ in the morning of operation day</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women diagnosed with early-stage breast cancer (including ductal carcinoma in-situ)&#xD;
             who are clinically or radiologically node-negative and consenting for sentinel lymph&#xD;
             node biopsy&#xD;
&#xD;
          -  Patients undergoing SNOLL (Sentinel node and occult lesion localization) with the use&#xD;
             of radio-isotope in our Breast Centre&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with clinically T3 or T4 breast cancer and any contraindication to sentinel&#xD;
             lymph node biopsy&#xD;
&#xD;
          -  Patients with pacemaker or other implantable device in the chest wall&#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>Yolanda Chan, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kwong Wah Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yolanda Chan, MBBS</last_name>
    <phone>+852 9785 4221</phone>
    <email>chy168@ha.org.hk</email>
  </overall_contact>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>February 15, 2017</last_update_submitted>
  <last_update_submitted_qc>February 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Kwong Wah Hospital</investigator_affiliation>
    <investigator_full_name>Yolanda Chan</investigator_full_name>
    <investigator_title>Associate Consultant</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast 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/NCT03036475
org study id: 107-15
nct id: NCT03036475
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
The aim of this study is to evaluate a new method for the localization of breast cancer
      sentinel lymph node using Sienna+® and Sentimag® detection in comparison to our standard
      techniques with radio-isotopes.
The use of radioisotope with or without blue dye has long become the gold standard for
      sentinel lymph node localization in the management of breast cancer. The latest evidence from
      a number of European trials has proven that a new tracer agent, superparamagnetic iron oxide
      particles (SPIOs, Sienna+®), is non-inferior to the standard method of lymphatic mapping. Its
      application and feasibility has yet been tried in most Asian countries.

      This is a prospective paired comparison trial involving both the new magnetic technique and
      the standard method. Patients with preoperative diagnosis of invasive carcinoma or ductal
      carcinoma in-situ of the breast undergoing SNOLL (Sentinel node and occult lesion
      localization) will be recruited from the Breast Centre of Kwong Wah Hospital. Informed
      consent will be obtained. All patients recruited will receive subcutaneous injection of 2 ml
      of Sienna+® diluted with saline to 5 ml at Breast Centre in the morning of operation,
      followed by five minutes of massage to the injection site. Before incision, on-table
      transcutaneous detection with the handheld magnetometer are carried out after at least 20
      minutes from injection. Intraoperative counts of sentinel lymph nodes identified as well as
      the ex-vivo counts of excised nodes are also measured. All procedures are supplemented with
      localization by radioisotope. All lymph nodes excised will be sent for histopathological
      examination.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Proportion of successful procedures for sentinel lymph node identification (identification rate per patient) by the magnetic method compared with the standard method
time frame: Two years
intervention type: Device
intervention name: Sienna+ injection
description: Subcutaneous injection of Sienna+ in the morning of operation day
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yolanda Chan, MBBS
role: Principal Investigator
affiliation: Kwong Wah Hospital
last name: Yolanda Chan, MBBS
phone: +852 9785 4221
email: chy168@ha.org.hk
responsible party type: Sponsor-Investigator
investigator affiliation: Kwong Wah Hospital
investigator full name: Yolanda Chan
investigator title: Associate Consultant
mesh term: Breast Neoplasms
sharing ipd: No