Comparison Trial of Open-tip Pulsed Needle Biopsy and Conventional Core Biopsy in Axillary Lymph Nodes (COMPULSE)
Breast Cancer
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast Cancer, Axillary Lymph Nodes, Biopsy
Eligibility Criteria
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
Sites / Locations
- Basildon University HospitalRecruiting
- Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
- Thirlestaine Breast Centre, Gloucestershire Hospitals NHS FoundationRecruiting
- Darlington Memorial HospitalRecruiting
- University Hospital of North Durham
- Western General Hospital, Lothian NHS TrustRecruiting
- Northwick Park HospitalRecruiting
- Hull University Teaching Hospitals NHS Trust
- St James's University Hospital, Leeds Teaching Hospitals NHS TrustRecruiting
- King Edward VII's Hospital, BARTS Health NHS TrustRecruiting
- Wythenshawe Hospital, Manchester University NHS Foundation TrustRecruiting
- North Manchester General HospitalRecruiting
- Southend University Hospital
- The Royal Marsden, The Royal Marsden NHS Foundation Trust
- Royal Cornwall Hospital
- High Wycombe HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Open-tip pulsed needle biopsy
Conventional core needle biopsy (CNB)
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).
Standard of care core needle biopsy used currently in clinics for biopsy procedures