xml: <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/NCT05963464</url>
    </required_header>
    <id_info>
      <org_study_id>IEO 1911/</org_study_id>
      <nct_id>NCT05963464</nct_id>
    </id_info>
    <brief_title>SCOUT® Radar Localization in Nonpalpable Breast Lesions</brief_title>
    <acronym>SAVISCOUT</acronym>
    <official_title>SCOUT® Radar Localization: Experience With 300 Patients at the European Institute of Oncology</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>European Institute of Oncology</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>European Institute of Oncology</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a monocentric prospective observational study for patients with clinical undetectable&#xD;
        breast lesions and indications to breast conserving surgery for histological&#xD;
        characterization.&#xD;
  &#xD;
        The SCOUT® Radar occult breast lesion Localization (SRL) consists of an implantable&#xD;
        reflector, a detector handpiece and a console and it uses non-radioactive micro-impulses to&#xD;
        guide surgical excision in real time.&#xD;
  &#xD;
        The study describes the experience with 300 patients at the European Institute of Oncology.&#xD;
  &#xD;
        The primary endpoints of the study are the rates of successful positioning, localization and&#xD;
        recovery of the reflector SRL.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        It has been estimated that 31,8% of breast cancer patients undergo pre-operational lesion&#xD;
        localization. Of them, 19% have been previously administered neoadjuvant chemotherapy (NACT).&#xD;
        Based on retrospective data, NACT administration is believed to steadily increase by 1,3%,&#xD;
        each year.&#xD;
  &#xD;
        The IEO Breast Division Program aims at improving the treatment and planning options&#xD;
        available to patients referred for radio guided breast surgery.&#xD;
  &#xD;
        At IEO, ROLL remains the standard of care. From its inception 25 year ago to the present&#xD;
        day,the investigators have gained significant expertise and now perform more than 1000&#xD;
        procedures per year.&#xD;
  &#xD;
        The investigators believe that SRL (SCOUT® Radar occult breast lesion Localization) could be&#xD;
        added to the procedure of reference in the following cases, still under investigation, where&#xD;
        it seems to present some advantages when compared to ROLL:&#xD;
  &#xD;
          1. Long-term positioning of the reflector, as in the case of patients undergoing&#xD;
             neoadjuvant treatment&#xD;
  &#xD;
          2. Reflector placement in malignant lymphadenopathy prior to neoadjuvant chemotherapy&#xD;
  &#xD;
          3. Placement of multiple reflectors, or use of both SRL and ROLL in patients with&#xD;
             multifocal or multicentric neoplasia referred for conservative surgery&#xD;
  &#xD;
          4. BI-RADS 5 patients suspected for ductal carcinoma in situ (DCIS) and eligible for&#xD;
             conservative surgery, could undergo reflector placement after vacuum-assisted breast&#xD;
             biopsy (VABB) and also be scheduled for Monday morning surgery&#xD;
  &#xD;
          5. Placement of the reflector using MR-compatible introducer needles&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of successful positioning of the reflector</measure>
      <time_frame>1 week</time_frame>
      <description>Percentage of reflectors successfull positioned</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of successful localization of the reflector</measure>
      <time_frame>6 months</time_frame>
      <description>Percentage of reflectors successfull localized</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of successful recovery of the reflector</measure>
      <time_frame>6 months</time_frame>
      <description>Percentage of reflectors successfull recovered</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rate of cases with negative margins</measure>
      <time_frame>6 months</time_frame>
      <description>percentage of cases with negative margins</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of cases that have required a second excision</measure>
      <time_frame>6 months</time_frame>
      <description>Percentage of cases that have required a second excision</description>
    </secondary_outcome>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Breast Cancer</condition>
    <condition>Occult Breast Carcinoma</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>SCOUT® Radar occult breast lesion Localization</intervention_name>
      <description>The SCOUT® Radar occult breast lesion Localization (SRL) uses non-radioactive micro-impulses to guide surgical excision in real time.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with diagnosis of nonpalpable breast lesion or lymph nodes requiring conservative&#xD;
          surgical excision.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of nonpalpable breast or lymph nodes&#xD;
  &#xD;
            -  Patients referred to IEO for breast surgery&#xD;
  &#xD;
            -  Patients between 18 and 90 years old&#xD;
  &#xD;
            -  Female patients&#xD;
  &#xD;
            -  Conservative surgery&#xD;
  &#xD;
            -  Patients willing and able to follow the study procedures and available for follow-up&#xD;
               over the entire duration of the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients known or suspected to be allergic to materials similar to those in the SAVI&#xD;
               SCOUT components (nickel)&#xD;
  &#xD;
            -  Any condition that may expose the individual to a higher risk or preclude the study&#xD;
               from achieving full compliance or completion.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gianmatteo Pagani, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>European Institute of Oncology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Gianmatteo Pagani, MD</last_name>
      <phone>+390257489</phone>
      <phone_ext>308</phone_ext>
      <email>gianmatteo.pagani@ieo.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Claudia Sangalli, MSc</last_name>
      <phone>+390257489</phone>
      <phone_ext>840</phone_ext>
      <email>claudia.sangalli@ieo.it</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>European Institute of Oncology</name>
        <address>
          <city>Milan</city>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Pagani Gianmatteo, MD</last_name>
        <email>gianmatteo.pagani@ieo.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </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>
  
  
text: 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/NCT05963464
  org study id: IEO 1911/
  nct id: NCT05963464
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a monocentric prospective observational study for patients with clinical undetectable
        breast lesions and indications to breast conserving surgery for histological
        characterization.
  
        The SCOUT® Radar occult breast lesion Localization (SRL) consists of an implantable
        reflector, a detector handpiece and a console and it uses non-radioactive micro-impulses to
        guide surgical excision in real time.
  
        The study describes the experience with 300 patients at the European Institute of Oncology.
  
        The primary endpoints of the study are the rates of successful positioning, localization and
        recovery of the reflector SRL.
  It has been estimated that 31,8% of breast cancer patients undergo pre-operational lesion
        localization. Of them, 19% have been previously administered neoadjuvant chemotherapy (NACT).
        Based on retrospective data, NACT administration is believed to steadily increase by 1,3%,
        each year.
  
        The IEO Breast Division Program aims at improving the treatment and planning options
        available to patients referred for radio guided breast surgery.
  
        At IEO, ROLL remains the standard of care. From its inception 25 year ago to the present
        day,the investigators have gained significant expertise and now perform more than 1000
        procedures per year.
  
        The investigators believe that SRL (SCOUT® Radar occult breast lesion Localization) could be
        added to the procedure of reference in the following cases, still under investigation, where
        it seems to present some advantages when compared to ROLL:
  
          1. Long-term positioning of the reflector, as in the case of patients undergoing
             neoadjuvant treatment
  
          2. Reflector placement in malignant lymphadenopathy prior to neoadjuvant chemotherapy
  
          3. Placement of multiple reflectors, or use of both SRL and ROLL in patients with
             multifocal or multicentric neoplasia referred for conservative surgery
  
          4. BI-RADS 5 patients suspected for ductal carcinoma in situ (DCIS) and eligible for
             conservative surgery, could undergo reflector placement after vacuum-assisted breast
             biopsy (VABB) and also be scheduled for Monday morning surgery
  
          5. Placement of the reflector using MR-compatible introducer needles
  observational model: Case-Only
  time perspective: Prospective
  measure: Rate of successful positioning of the reflector
  time frame: 1 week
  description: Percentage of reflectors successfull positioned
  measure: Rate of successful localization of the reflector
  time frame: 6 months
  description: Percentage of reflectors successfull localized
  measure: Rate of successful recovery of the reflector
  time frame: 6 months
  description: Percentage of reflectors successfull recovered
  measure: Rate of cases with negative margins
  time frame: 6 months
  description: percentage of cases with negative margins
  measure: Rate of cases that have required a second excision
  time frame: 6 months
  description: Percentage of cases that have required a second excision
  intervention type: Device
  intervention name: SCOUT® Radar occult breast lesion Localization
  description: The SCOUT® Radar occult breast lesion Localization (SRL) uses non-radioactive micro-impulses to guide surgical excision in real time.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Gianmatteo Pagani, MD
  role: Principal Investigator
  affiliation: European Institute of Oncology
  last name: Gianmatteo Pagani, MD
  phone: +390257489
  phone ext: 308
  email: gianmatteo.pagani@ieo.it
  last name: Claudia Sangalli, MSc
  phone: +390257489
  phone ext: 840
  email: claudia.sangalli@ieo.it
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  sharing ipd: No