Evaluation of NeoNavia® Biopsy System in Axillary Lymph Nodes
Evaluation of NeoNavia® Biopsy System in Axillary Lymph Nodes
The aim of the study is to document performance characteristics of a biopsy device indicated
 for use in axillary lymph nodes, to provide basic insights into the complexity of axillary
 biopsy procedures and generate hypothesis for further larger comparative trials.

 This is a Sponsor-initiated prospective, multicenter, registry trial. Patients that present
 with suspicious axillary lymph nodes at the time of breast cancer diagnosis undergo axillary
 sampling using the NeoNavia biopsy system. This is in accordance with clinical routine and
 current clinical guidelines. The system incorporates a new mechanism for controllable and
 precise needle insertion and a newly developed sampling needle for high yield sampling
 acquisition. It is approved for use in the breast and axillary lymph nodes.
Determining axillary nodal status at the time of diagnosis is paramount for optimal staging
 and treatment planning. SLNB is indicated for patients with a clinical and radiological
 negative axilla. 25%-43% of breast cancer patients are reported to present with
 radiologically suspicious axillary lymph nodes at the time of diagnosis. In these patients, a
 pre-operative ultrasound-guided needle sampling of suspicious axillary lymph tissue is
 indicated.

 This can rationalize patient care by identifying those with axillary metastases using merely
 a minimally-invasive intervention. These patients can be counselled with regards to
 proceeding directly to definitive axillary surgery in the form of axillary lymph node
 dissection (ALND) rather than sentinel node biopsy (SLNB), thereby omitting a potentially
 unnecessary surgical procedure. Patients with a negative axillary status can proceed to SLNB
 for definitive nodal status determination. Furthermore, in the paradigm of neoadjuvant
 treatment, confirming a histopathologic involvement of lymph nodes by US-guided needle
 biopsies enables for decision on neoadjuvant chemotherapy without the need for a surgical
 procedure.

 The main challenge in performing CNB (Core Needle Biopsy) within the axilla is to avoid
 damaging the major vessels and nerves. Technical, operator and procedural requirements that
 mitigate risks in CNB sampling of the axilla have been reported in the literature. It is
 suggested that the operator shall fully acknowledge the detailed anatomy including vessels
 and nerves in the axilla, have good hand-eye coordination as well as be experienced in
 US-guided interventions. Proper positioning of the patient is reported to be important. Color
 Doppler ultrasound shall be used to assess the location of large vessels relative to the
 intended biopsy track and to avoid sampling a vascular component of the node. Perfect guiding
 and visualization of the needle tip at all times is reported to be essential. It is suggested
 that a biopsy device with a controllable needle action is safer to use. Omitting the firing
 action gives the operator greater control over the final needle tip placement.

 Due to the difficulty of the procedure there may be inclusion bias in the reported studies.
 In one series, patients presenting with nodes adjacent to a vessel or located very deep and
 difficult to access were not asked to participate in the study and hence not subjected to
 CNB. In another study FNA (Fine Needle Aspiration) was performed instead of CNB when the
 lymph nodes were in close proximity to vessels. A recent German survey showed that merely 79%
 of breast centers (41/52) perform biopsies in the axilla (data on file), and anecdotal
 evidence suggests that in certain departments only the most experienced physician performs
 CNB procedures in axillary lymph nodes, risking economic/operational inefficiencies.

 For the purpose of documenting the prevalence and composition of cases deemed challenging in
 this study, an experienced expert panel has compiled a comprehensive list of risk parameters
 characterizing the anatomic complexity and procedural difficulty of axillary lymph node
 needle biopsies.

 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 higher sampling yield compared to
 CNB. These characteristics indicate that the device could be well suited for tackling even
 the most challenging cases of 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:

 -  cT1-4c (multifocality / multicentricity permitted)

 -  Female / male patient aged ≥ 18 years

 -  cN+ based on the following criteria (at least one criteria must be met):

 -  lymph node is palpable

 -  cortical asymmetry (focal or diffuse cortical thickening of >3mm) under US

 -  cortex:hilum ratio >2:1 under US

 -  loss of hilum/cortex structure under US

 -  Written informed consent (ICF)

 Exclusion Criteria:

 -  Suspicious lymph nodes after neoadjuvant therapy

 -  No confirmed breast cancer and no abnormality in the breast

 -  Patient uses Marcumar

 -  Pregnant and lactating women

 -  Known hypersensitivity reaction against local anesthesia

 -  Prior chemo or radiation therapy in breast or axilla

 -  Missing written informed consent