<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/NCT04500262</url>
  </required_header>
  <id_info>
    <org_study_id>NEODOC- 2021668610-221</org_study_id>
    <nct_id>NCT04500262</nct_id>
  </id_info>
  <brief_title>Comparison Trial of Open-tip Pulsed Needle Biopsy and Conventional Core Biopsy in Axillary Lymph Nodes</brief_title>
  <acronym>COMPULSE</acronym>
  <official_title>Comparison Trial of Open-tip Pulsed Needle Biopsy and Conventional Core Biopsy in Axillary Lymph Nodes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NeoDynamics AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NeoDynamics AB</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>
      The aim of the study is to compare performance and safety of a newly developed 14-gauge&#xD;
      open-tip pulsed biopsy needle with a conventional 14-gauge core biopsy needle for sampling of&#xD;
      radiologically indeterminate or suspicious axillary lymph nodes in women with radiologically&#xD;
      suspected breast cancer.&#xD;
&#xD;
      This is a Sponsor-initiated multicentre randomised trial. At the time of radiological breast&#xD;
      cancer diagnosis women with ultrasonically abnormal lymph nodes undergo axillary sampling&#xD;
      using the NeoNavia biopsy system or a common CNB device. This is in accordance with clinical&#xD;
      routine and current clinical guidelines. The NeoNavia biopsy system is approved for use in&#xD;
      the axillary lymph nodes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is the standard of care in the United Kingdom for women with suspected or confirmed breast&#xD;
      cancer to undergo ultrasound of the ipsilateral axilla prior to surgery in order to detect&#xD;
      nodal metastatic disease. Women with invasive breast cancer and normal axillary ultrasound&#xD;
      will then undergo operative sentinel lymph node biopsy. This is usually at the same time as&#xD;
      the surgical removal of the breast cancer by wide local excision or mastectomy but may be&#xD;
      done as a separate procedure before (e.g. where neoadjuvant chemotherapy is planned) or after&#xD;
      (e.g. if a non-operative diagnosis of invasive breast cancer was not made prior to surgery).&#xD;
      Women who are found to have a positive sentinel lymph node biopsy (i.e. have axillary&#xD;
      metastatic disease) normally undergo axillary node clearance (ANC) at a subsequent operation.&#xD;
      This policy may change in the future, as evidence from the American Z0011 study suggests that&#xD;
      women with low volume axillary metastatic disease do as well with no further axillary surgery&#xD;
      plus standard adjuvant treatment as those that undergo ANC.&#xD;
&#xD;
      Women who have abnormal lymph nodes on axillary ultrasound undergo tissue sampling with core&#xD;
      needle biopsy (CNB), usually 14 Gauge (14G) under local anaesthetic or with fine needle&#xD;
      aspiration cytology (FNAC). Women with proven axillary nodal metastases will then usually&#xD;
      undergo axillary node clearance at the same operation as surgical removal of the primary&#xD;
      tumour.&#xD;
&#xD;
      The number of women who need to undergo more than one operation can therefore be minimised by&#xD;
      maximising the number of women with axillary metastatic disease in whom this diagnosis is&#xD;
      made preoperatively.&#xD;
&#xD;
      Meta-analyses of published studies and more recent studies suggest that ultrasound has a&#xD;
      sensitivity of ~60% and specificity of ~80% for the detection of metastatic lymph nodes.&#xD;
      Although no randomised comparisons of 14G core needle biopsy (CNB) and FNAC have been&#xD;
      performed, several studies have suggested that CNB is more accurate. Ultrasound-guided biopsy&#xD;
      of nodes subsequently proven at surgery to contain metastases has a sensitivity of ~80% and a&#xD;
      specificity of 100% and is more likely to be positive in those women with a higher nodal&#xD;
      burden. Numerous studies suggest that increasing the volume of tissue removed may increase&#xD;
      the diagnostic yield.&#xD;
&#xD;
      Recently a new biopsy device indicated for the use in breast and axillary lymph nodes&#xD;
      (NeoNavia biopsy system, NeoDynamics, Sweden) has become available. It incorporates a&#xD;
      pneumatic needle insertion mechanism that is intended to provide better control of needle&#xD;
      progression and enable stepwise insertion without noticeable deformation or displacement of&#xD;
      surrounding tissue as visualized under ultrasound. Furthermore a new method of tissue&#xD;
      acquisition is employed that has pre-clinically shown a significantly higher sampling yield&#xD;
      compared to CNB. These characteristics indicate that the device could be well suited for&#xD;
      axillary lymph node biopsies. Initial clinical results indicate that in axillary lesions&#xD;
      deemed &quot;technically difficult&quot;, i.e. where prior US-guided biopsies with CNB or FNA had&#xD;
      yielded non-diagnostic histology results, the NeoNavia device performed successfully, thereby&#xD;
      significantly altering clinical management.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 13, 2020</start_date>
  <completion_date type="Anticipated">March 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2024</primary_completion_date>
  <phase>N/A</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of adequacy rate of tissue sampling of axillary lymph nodes under local anaesthetic with open-tip pulsed needle biopsy (OT-PNB) and conventional 14-gauge core needle core biopsy (CNB)</measure>
    <time_frame>After histopathological analysis of tissue samples, up to 1 week after biopsy</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of pain scores for the two biopsy techniques immediately post-procedure and the maximum from days 1-3 post-procedure</measure>
    <time_frame>1-14 days</time_frame>
    <description>Pain questionnaire administered to the participant immediately following the procedure and 4-14 days post procedure (relating to days 1-3 post procedure). Scale 0-10; 0 means no pain, 10 is the worst pain imaginable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of complication rates between the two techniques</measure>
    <time_frame>0-14 days post-biopsy</time_frame>
    <description>Collection of AE's, SAE's and device deficiencies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the willingness of patients to undergo the procedure again if necessary</measure>
    <time_frame>4-14 days post-biopsy</time_frame>
    <description>Questionnaire administered to the participant on clinic visit for biopsy result</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of number of tissue samples taken with the two techniques and the number of device insertions per subject</measure>
    <time_frame>1 day</time_frame>
    <description>Biopsy procedure data collected in real time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the time taken for the two techniques (first biopsy device entry to last withdrawal)</measure>
    <time_frame>1 day</time_frame>
    <description>Biopsy procedure data collected in real time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the total weight of tissue obtained with the two techniques and the average weight per device insertion</measure>
    <time_frame>1 day</time_frame>
    <description>Samples are weighed in clinic or pathology following the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Users views upon whether the pulse technology of the NeoNavia® device facilitates accurate needle passage through the tissues to an optimum sampling position</measure>
    <time_frame>1 day</time_frame>
    <description>Yes/No, questionnaire given to radiologist</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Users views upon whether the pulse technology of the NeoNavia® device facilitates stabilisation of the target and control of the needle position</measure>
    <time_frame>1 day</time_frame>
    <description>Yes/No, questionnaire given to radiologist</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of sensitivity of preoperative axillary assessment of ultrasonically indeterminate or abnormal axillary lymph (calculated from the proportion of women with axillary metastatic disease at surgery).</measure>
    <time_frame>post-surgery</time_frame>
    <description>14-200 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of intended outcome of biopsy procedure, i.e. number of samples to be taken from respective lymph node, and actual outcome</measure>
    <time_frame>1 day</time_frame>
    <description>Biopsy procedure data</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">479</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Open-tip pulsed needle biopsy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Biopsy procedure using the NeoNavia biopsy system. The needle used in this study is of the same outside diameter as a standard biopsy needle used in the breast or axilla (14-gauge) but does not have a notched trochar like a conventional spring-loaded device. It does not have a redundant portion of needle beyond the sampling zone and takes full circumference cylindrical cores.&#xD;
A pneumatic system powered by a floor-standing base unit connected via a handheld driver to the biopsy device provides impulses to the needle, allowing the operator to advance the needle through tissue with little manual force (NeoNavia biopsy system, NeoDynamics, Sweden).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional core needle biopsy (CNB)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard of care core needle biopsy used currently in clinics for biopsy procedures</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Open-tip pulsed needle biopsy (NeoNavia Biopsy System)</intervention_name>
    <description>Ultrasound-guided biopsy using 14G open-tip pulsed biopsy needle</description>
    <arm_group_label>Open-tip pulsed needle biopsy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Core needle biopsy (CNB)</intervention_name>
    <description>Ultrasound-guided biopsy using standard of care core needle biopsy</description>
    <arm_group_label>Conventional core needle biopsy (CNB)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women in screening and symptomatic clinics aged 18 years or older with breast masses&#xD;
             scored as 1 of the following:&#xD;
&#xD;
               -  M3, M4 or M5 (mammographically uncertain, suspicious or highly suspicious of&#xD;
                  malignancy)&#xD;
&#xD;
               -  MRI5 (highly suspicious of malignancy on MRI)&#xD;
&#xD;
               -  U3, U4 or U5 (ultrasonically uncertain, suspicious or highly suspicious of&#xD;
                  malignancy)&#xD;
&#xD;
               -  have histologically proven breast cancer&#xD;
&#xD;
          -  who have ipsilateral axillary lymph nodes which are described as indeterminate or&#xD;
             suspicious for metastatic disease and indicated for biopsy, as determined by&#xD;
             individual breast unit criteria&#xD;
&#xD;
          -  are able to give informed consent for the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous ipsilateral axillary surgery&#xD;
&#xD;
          -  Target lymph node not suitable for needle biopsy due to its close proximity to&#xD;
             critical structures such as major blood vessels&#xD;
&#xD;
          -  Unable to give written informed consent in English&#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>Sarah Vinnicombe, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gloucestershire Hospitals NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kai-Uwe Schässburger, Ph.D.</last_name>
    <phone>+46(0)8 522 79 664</phone>
    <email>kai-uwe.schassburger@neodynamics.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Basildon University Hospital</name>
      <address>
        <city>Basildon</city>
        <zip>SS16 5NL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jessica Eades</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Thirlestaine Breast Centre, Gloucestershire Hospitals NHS Foundation</name>
      <address>
        <city>Cheltenham</city>
        <zip>GL53 7AS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sarah Vinnicombe, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Darlington Memorial Hospital</name>
      <address>
        <city>Darlington</city>
        <zip>DL36HX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bob Kent</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital of North Durham</name>
      <address>
        <city>Durham</city>
        <zip>DH1 5TW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Western General Hospital, Lothian NHS Trust</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH4 2XU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melanie Smith, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Northwick Park Hospital</name>
      <address>
        <city>Harrow</city>
        <zip>HA1 3UJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mia Morgan, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hull University Teaching Hospitals NHS Trust</name>
      <address>
        <city>Hull</city>
        <zip>HU165JQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Joanna Wieczorek, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>St James's University Hospital, Leeds Teaching Hospitals NHS Trust</name>
      <address>
        <city>Leeds</city>
        <zip>LS9 7TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nisha Sharma, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>King Edward VII's Hospital, BARTS Health NHS Trust</name>
      <address>
        <city>London</city>
        <zip>W1G 6AA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tamara Suaris, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Wythenshawe Hospital, Manchester University NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <zip>M23 9LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gillian Hutchinson, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>North Manchester General Hospital</name>
      <address>
        <city>Manchester</city>
        <zip>M8 5RB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alison Darlington, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Southend University Hospital</name>
      <address>
        <city>Southend</city>
        <zip>SS00RY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Tania Mercado, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Royal Marsden, The Royal Marsden NHS Foundation Trust</name>
      <address>
        <city>Sutton</city>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Royal Cornwall Hospital</name>
      <address>
        <city>Truro</city>
        <zip>TR13LJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>High Wycombe Hospital</name>
      <address>
        <city>Wycombe</city>
        <zip>HP11 2TT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chin Lian NG, Dr</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://www.neodynamics.se/en/upl/files/161457</url>
    <description>Lee et al, NeoNavia biopsy system: Our experience of a new device for more precise ultrasound-guided percutaneous core biopsy of axillary lymph nodes, British Society of Breast Radiology Annual Scientific Meeting 2017</description>
  </link>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/29519406/</url>
    <description>Schässburger et al. High velocity pulse biopsy device enables controllable and precise needle insertion and high yield tissue acquisition. Phys Med. 2018 Feb;46:25-31. doi: 10.1016/j.ejmp.2017.12.014. Epub 2018 Jan 30.</description>
  </link>
  <reference>
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  <reference>
    <citation>van Wely BJ, de Wilt JH, Francissen C, Teerenstra S, Strobbe LJ. Meta-analysis of ultrasound-guided biopsy of suspicious axillary lymph nodes in the selection of patients with extensive axillary tumour burden in breast cancer. Br J Surg. 2015 Feb;102(3):159-68. doi: 10.1002/bjs.9663. Epub 2014 Oct 29.</citation>
    <PMID>25354962</PMID>
  </reference>
  <reference>
    <citation>Lee J, Bishop B, Allen S. NeoNavia biopsy system: Our experience of a new device for more precise ultrasound-guided percutaneous core biopsy of axillary lymph nodes. Breast Cancer Res 2017;19(suppl 1):18.</citation>
  </reference>
  <reference>
    <citation>Abe H, Schmidt RA, Sennett CA, Shimauchi A, Newstead GM. US-guided core needle biopsy of axillary lymph nodes in patients with breast cancer: why and how to do it. Radiographics. 2007 Oct;27 Suppl 1:S91-9. doi: 10.1148/rg.27si075502.</citation>
    <PMID>18180238</PMID>
  </reference>
  <reference>
    <citation>Abe H, Schmidt RA, Kulkarni K, Sennett CA, Mueller JS, Newstead GM. Axillary lymph nodes suspicious for breast cancer metastasis: sampling with US-guided 14-gauge core-needle biopsy--clinical experience in 100 patients. Radiology. 2009 Jan;250(1):41-9. doi: 10.1148/radiol.2493071483. Epub 2008 Oct 27.</citation>
    <PMID>18955508</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>May 30, 2023</last_update_submitted>
  <last_update_submitted_qc>May 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <keyword>Axillary Lymph Nodes</keyword>
  <keyword>Biopsy</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/NCT04500262
org study id: NEODOC- 2021668610-221
nct id: NCT04500262
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to compare performance and safety of a newly developed 14-gauge
      open-tip pulsed biopsy needle with a conventional 14-gauge core biopsy needle for sampling of
      radiologically indeterminate or suspicious axillary lymph nodes in women with radiologically
      suspected breast cancer.

      This is a Sponsor-initiated multicentre randomised trial. At the time of radiological breast
      cancer diagnosis women with ultrasonically abnormal lymph nodes undergo axillary sampling
      using the NeoNavia biopsy system or a common CNB device. This is in accordance with clinical
      routine and current clinical guidelines. The NeoNavia biopsy system is approved for use in
      the axillary lymph nodes.
It is the standard of care in the United Kingdom for women with suspected or confirmed breast
      cancer to undergo ultrasound of the ipsilateral axilla prior to surgery in order to detect
      nodal metastatic disease. Women with invasive breast cancer and normal axillary ultrasound
      will then undergo operative sentinel lymph node biopsy. This is usually at the same time as
      the surgical removal of the breast cancer by wide local excision or mastectomy but may be
      done as a separate procedure before (e.g. where neoadjuvant chemotherapy is planned) or after
      (e.g. if a non-operative diagnosis of invasive breast cancer was not made prior to surgery).
      Women who are found to have a positive sentinel lymph node biopsy (i.e. have axillary
      metastatic disease) normally undergo axillary node clearance (ANC) at a subsequent operation.
      This policy may change in the future, as evidence from the American Z0011 study suggests that
      women with low volume axillary metastatic disease do as well with no further axillary surgery
      plus standard adjuvant treatment as those that undergo ANC.

      Women who have abnormal lymph nodes on axillary ultrasound undergo tissue sampling with core
      needle biopsy (CNB), usually 14 Gauge (14G) under local anaesthetic or with fine needle
      aspiration cytology (FNAC). Women with proven axillary nodal metastases will then usually
      undergo axillary node clearance at the same operation as surgical removal of the primary
      tumour.

      The number of women who need to undergo more than one operation can therefore be minimised by
      maximising the number of women with axillary metastatic disease in whom this diagnosis is
      made preoperatively.

      Meta-analyses of published studies and more recent studies suggest that ultrasound has a
      sensitivity of ~60% and specificity of ~80% for the detection of metastatic lymph nodes.
      Although no randomised comparisons of 14G core needle biopsy (CNB) and FNAC have been
      performed, several studies have suggested that CNB is more accurate. Ultrasound-guided biopsy
      of nodes subsequently proven at surgery to contain metastases has a sensitivity of ~80% and a
      specificity of 100% and is more likely to be positive in those women with a higher nodal
      burden. Numerous studies suggest that increasing the volume of tissue removed may increase
      the diagnostic yield.

      Recently a new biopsy device indicated for the use in breast and axillary lymph nodes
      (NeoNavia biopsy system, NeoDynamics, Sweden) has become available. It incorporates a
      pneumatic needle insertion mechanism that is intended to provide better control of needle
      progression and enable stepwise insertion without noticeable deformation or displacement of
      surrounding tissue as visualized under ultrasound. Furthermore a new method of tissue
      acquisition is employed that has pre-clinically shown a significantly higher sampling yield
      compared to CNB. These characteristics indicate that the device could be well suited for
      axillary lymph node biopsies. Initial clinical results indicate that in axillary lesions
      deemed "technically difficult", i.e. where prior US-guided biopsies with CNB or FNA had
      yielded non-diagnostic histology results, the NeoNavia device performed successfully, thereby
      significantly altering clinical management.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Comparison of adequacy rate of tissue sampling of axillary lymph nodes under local anaesthetic with open-tip pulsed needle biopsy (OT-PNB) and conventional 14-gauge core needle core biopsy (CNB)
time frame: After histopathological analysis of tissue samples, up to 1 week after biopsy
measure: Comparison of pain scores for the two biopsy techniques immediately post-procedure and the maximum from days 1-3 post-procedure
time frame: 1-14 days
description: Pain questionnaire administered to the participant immediately following the procedure and 4-14 days post procedure (relating to days 1-3 post procedure). Scale 0-10; 0 means no pain, 10 is the worst pain imaginable.
measure: Comparison of complication rates between the two techniques
time frame: 0-14 days post-biopsy
description: Collection of AE's, SAE's and device deficiencies
measure: Comparison of the willingness of patients to undergo the procedure again if necessary
time frame: 4-14 days post-biopsy
description: Questionnaire administered to the participant on clinic visit for biopsy result
measure: Comparison of number of tissue samples taken with the two techniques and the number of device insertions per subject
time frame: 1 day
description: Biopsy procedure data collected in real time
measure: Comparison of the time taken for the two techniques (first biopsy device entry to last withdrawal)
time frame: 1 day
description: Biopsy procedure data collected in real time
measure: Comparison of the total weight of tissue obtained with the two techniques and the average weight per device insertion
time frame: 1 day
description: Samples are weighed in clinic or pathology following the procedure
measure: Users views upon whether the pulse technology of the NeoNavia® device facilitates accurate needle passage through the tissues to an optimum sampling position
time frame: 1 day
description: Yes/No, questionnaire given to radiologist
measure: Users views upon whether the pulse technology of the NeoNavia® device facilitates stabilisation of the target and control of the needle position
time frame: 1 day
description: Yes/No, questionnaire given to radiologist
measure: Comparison of sensitivity of preoperative axillary assessment of ultrasonically indeterminate or abnormal axillary lymph (calculated from the proportion of women with axillary metastatic disease at surgery).
time frame: post-surgery
description: 14-200 days
measure: Comparison of intended outcome of biopsy procedure, i.e. number of samples to be taken from respective lymph node, and actual outcome
time frame: 1 day
description: Biopsy procedure data
arm group label: Open-tip pulsed needle biopsy
arm group type: Active Comparator
description: Biopsy procedure using the NeoNavia biopsy system. The needle used in this study is of the same outside diameter as a standard biopsy needle used in the breast or axilla (14-gauge) but does not have a notched trochar like a conventional spring-loaded device. It does not have a redundant portion of needle beyond the sampling zone and takes full circumference cylindrical cores.
A pneumatic system powered by a floor-standing base unit connected via a handheld driver to the biopsy device provides impulses to the needle, allowing the operator to advance the needle through tissue with little manual force (NeoNavia biopsy system, NeoDynamics, Sweden).
arm group label: Conventional core needle biopsy (CNB)
arm group type: Active Comparator
description: Standard of care core needle biopsy used currently in clinics for biopsy procedures
intervention type: Device
intervention name: Open-tip pulsed needle biopsy (NeoNavia Biopsy System)
description: Ultrasound-guided biopsy using 14G open-tip pulsed biopsy needle
arm group label: Open-tip pulsed needle biopsy
intervention type: Device
intervention name: Core needle biopsy (CNB)
description: Ultrasound-guided biopsy using standard of care core needle biopsy
arm group label: Conventional core needle biopsy (CNB)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sarah Vinnicombe, Dr
role: Principal Investigator
affiliation: Gloucestershire Hospitals NHS Foundation Trust
last name: Kai-Uwe Schässburger, Ph.D.
phone: +46(0)8 522 79 664
email: kai-uwe.schassburger@neodynamics.com
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
country: United Kingdom
url: http://www.neodynamics.se/en/upl/files/161457
description: Lee et al, NeoNavia biopsy system: Our experience of a new device for more precise ultrasound-guided percutaneous core biopsy of axillary lymph nodes, British Society of Breast Radiology Annual Scientific Meeting 2017
url: https://pubmed.ncbi.nlm.nih.gov/29519406/
description: Schässburger et al. High velocity pulse biopsy device enables controllable and precise needle insertion and high yield tissue acquisition. Phys Med. 2018 Feb;46:25-31. doi: 10.1016/j.ejmp.2017.12.014. Epub 2018 Jan 30.
citation: Houssami N, Turner RM. Staging the axilla in women with breast cancer: the utility of preoperative ultrasound-guided needle biopsy. Cancer Biol Med. 2014 Jun;11(2):69-77. doi: 10.7497/j.issn.2095-3941.2014.02.001.
PMID: 25009748
citation: Topps AR, Barr SP, Pikoulas P, Pritchard SA, Maxwell AJ. Pre-operative Axillary Ultrasound-Guided Needle Sampling in Breast Cancer: Comparing the Sensitivity of Fine Needle Aspiration Cytology and Core Needle Biopsy. Ann Surg Oncol. 2018 Jan;25(1):148-153. doi: 10.1245/s10434-017-6090-1. Epub 2017 Oct 23.
PMID: 29063297
citation: Britton PD, Provenzano E, Barter S, Gaskarth M, Goud A, Moyle P, Sinnatamby R, Wallis M, Benson JR, Forouhi P, Wishart GC. Ultrasound guided percutaneous axillary lymph node core biopsy: how often is the sentinel lymph node being biopsied? Breast. 2009 Feb;18(1):13-6. doi: 10.1016/j.breast.2008.09.003. Epub 2008 Nov 7.
PMID: 18993074
citation: Macaskill EJ, Purdie CA, Jordan LB, Mclean D, Whelehan P, Brown DC, Evans A. Axillary lymph node core biopsy for breast cancer metastases -- how many needle passes are enough? Clin Radiol. 2012 May;67(5):417-9. doi: 10.1016/j.crad.2011.10.006. Epub 2011 Nov 26.
PMID: 22119100
citation: Maxwell AJ, Bundred NJ, Harvey J, Hunt R, Morris J, Lim YY. A randomised pilot study comparing 13 G vacuum-assisted biopsy and conventional 14 G core needle biopsy of axillary lymph nodes in women with breast cancer. Clin Radiol. 2016 Jun;71(6):551-7. doi: 10.1016/j.crad.2016.02.024. Epub 2016 Mar 31.
PMID: 27040801
citation: Giuliano AE, Hunt KK, Ballman KV, Beitsch PD, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, McCall LM, Morrow M. Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. JAMA. 2011 Feb 9;305(6):569-75. doi: 10.1001/jama.2011.90.
PMID: 21304082
citation: POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer (POSNOC). ClinicaltrialsGov n.d. https://clinicaltrials.gov/ct2/show/NCT02401685 (accessed February 18, 2019)
citation: Alvarez S, Anorbe E, Alcorta P, Lopez F, Alonso I, Cortes J. Role of sonography in the diagnosis of axillary lymph node metastases in breast cancer: a systematic review. AJR Am J Roentgenol. 2006 May;186(5):1342-8. doi: 10.2214/AJR.05.0936.
PMID: 16632729
citation: Houssami N, Ciatto S, Turner RM, Cody HS 3rd, Macaskill P. Preoperative ultrasound-guided needle biopsy of axillary nodes in invasive breast cancer: meta-analysis of its accuracy and utility in staging the axilla. Ann Surg. 2011 Aug;254(2):243-51. doi: 10.1097/SLA.0b013e31821f1564.
PMID: 21597359
citation: Joh JE, Han G, Kiluk JV, Laronga C, Khakpour N, Lee MC. Indications for axillary ultrasound use in breast cancer patients. Clin Breast Cancer. 2012 Dec;12(6):433-7. doi: 10.1016/j.clbc.2012.09.009. Epub 2012 Oct 11.
PMID: 23062709
citation: Leenders MW, Broeders M, Croese C, Richir MC, Go HL, Langenhorst BL, Meijer S, Schreurs WH. Ultrasound and fine needle aspiration cytology of axillary lymph nodes in breast cancer. To do or not to do? Breast. 2012 Aug;21(4):578-83. doi: 10.1016/j.breast.2012.05.008. Epub 2012 Jun 19.
PMID: 22717665
citation: Rattay T, Muttalib M, Khalifa E, Duncan A, Parker SJ. Clinical utility of routine pre-operative axillary ultrasound and fine needle aspiration cytology in patient selection for sentinel lymph node biopsy. Breast. 2012 Apr;21(2):210-4. doi: 10.1016/j.breast.2011.09.014. Epub 2011 Oct 5.
PMID: 21981897
citation: Garcia-Ortega MJ, Benito MA, Vahamonde EF, Torres PR, Velasco AB, Paredes MM. Pretreatment axillary ultrasonography and core biopsy in patients with suspected breast cancer: diagnostic accuracy and impact on management. Eur J Radiol. 2011 Jul;79(1):64-72. doi: 10.1016/j.ejrad.2009.12.011. Epub 2010 Jan 4.
PMID: 20047809
citation: Rao R, Lilley L, Andrews V, Radford L, Ulissey M. Axillary staging by percutaneous biopsy: sensitivity of fine-needle aspiration versus core needle biopsy. Ann Surg Oncol. 2009 May;16(5):1170-5. doi: 10.1245/s10434-009-0421-9. Epub 2009 Mar 5.
PMID: 19263171
citation: Rautiainen S, Masarwah A, Sudah M, Sutela A, Pelkonen O, Joukainen S, Sironen R, Karja V, Vanninen R. Axillary lymph node biopsy in newly diagnosed invasive breast cancer: comparative accuracy of fine-needle aspiration biopsy versus core-needle biopsy. Radiology. 2013 Oct;269(1):54-60. doi: 10.1148/radiol.13122637. Epub 2013 Jun 14.
PMID: 23771915
citation: Ganott MA, Zuley ML, Abrams GS, Lu AH, Kelly AE, Sumkin JH, Chivukula M, Carter G, Austin RM, Bandos AI. Ultrasound Guided Core Biopsy versus Fine Needle Aspiration for Evaluation of Axillary Lymphadenopathy in Patients with Breast Cancer. ISRN Oncol. 2014 Feb 4;2014:703160. doi: 10.1155/2014/703160. eCollection 2014.
PMID: 24649373
citation: van Wely BJ, de Wilt JH, Francissen C, Teerenstra S, Strobbe LJ. Meta-analysis of ultrasound-guided biopsy of suspicious axillary lymph nodes in the selection of patients with extensive axillary tumour burden in breast cancer. Br J Surg. 2015 Feb;102(3):159-68. doi: 10.1002/bjs.9663. Epub 2014 Oct 29.
PMID: 25354962
citation: Lee J, Bishop B, Allen S. NeoNavia biopsy system: Our experience of a new device for more precise ultrasound-guided percutaneous core biopsy of axillary lymph nodes. Breast Cancer Res 2017;19(suppl 1):18.
citation: Abe H, Schmidt RA, Sennett CA, Shimauchi A, Newstead GM. US-guided core needle biopsy of axillary lymph nodes in patients with breast cancer: why and how to do it. Radiographics. 2007 Oct;27 Suppl 1:S91-9. doi: 10.1148/rg.27si075502.
PMID: 18180238
citation: Abe H, Schmidt RA, Kulkarni K, Sennett CA, Mueller JS, Newstead GM. Axillary lymph nodes suspicious for breast cancer metastasis: sampling with US-guided 14-gauge core-needle biopsy--clinical experience in 100 patients. Radiology. 2009 Jan;250(1):41-9. doi: 10.1148/radiol.2493071483. Epub 2008 Oct 27.
PMID: 18955508
responsible party type: Sponsor
mesh term: Breast Neoplasms