Comparison Trial of Open-tip Pulsed Needle Biopsy and Conventional Core Biopsy in Axillary Lymph Nodes
Comparison Trial of Open-tip Pulsed Needle Biopsy and Conventional Core Biopsy in Axillary Lymph Nodes
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.
Inclusion Criteria:

 -  Women in screening and symptomatic clinics aged >35 years with breast masses scored
 as:

 -  M4 or M5 (mammographically suspicious or highly suspicious of malignancy) and U5
 (ultrasonically highly suspicious of malignancy)

 -  and/or MRI5 (highly suspicious of malignancy on magnetic resonance imaging) and
 U5

 -  and/or have histologically proven breast cancer

 -  and who have ipsilateral axillary lymph nodes which are indeterminate or suspicious
 for metastatic disease (A3, 4 or 5), as determined by individual breast unit criteria

 -  have given written informed consent for the study

 Exclusion Criteria:

 -  Women who are on anticoagulants, antiplatelet drugs (inc. aspirin) or have known
 clotting disorders

 -  Previous ipsilateral axillary surgery

 -  Target lymph node not suitable for needle biopsy due to its close proximity to
 critical structures such as major blood vessels

 -  Unable to give written informed consent in English