Comparison Trial of Open-tip Pulsed Needle Biopsy and Conventional Core Biopsy in Axillary Lymph Nodes (COMPULSE)

May 30, 2023 updated by: NeoDynamics AB

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

479

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Basildon, United Kingdom, SS16 5NL
        • Recruiting
        • Basildon University Hospital
        • Contact:
          • Jessica Eades
      • Cambridge, United Kingdom, CB2 0QQ
        • Terminated
        • Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
      • Cheltenham, United Kingdom, GL53 7AS
        • Recruiting
        • Thirlestaine Breast Centre, Gloucestershire Hospitals NHS Foundation
        • Contact:
          • Sarah Vinnicombe, Dr
      • Darlington, United Kingdom, DL36HX
        • Recruiting
        • Darlington Memorial Hospital
        • Contact:
          • Bob Kent
      • Durham, United Kingdom, DH1 5TW
        • Terminated
        • University Hospital of North Durham
      • Edinburgh, United Kingdom, EH4 2XU
        • Recruiting
        • Western General Hospital, Lothian NHS Trust
        • Contact:
          • Melanie Smith, Dr
      • Harrow, United Kingdom, HA1 3UJ
        • Recruiting
        • Northwick Park Hospital
        • Contact:
          • Mia Morgan, Dr
      • Hull, United Kingdom, HU165JQ
        • Not yet recruiting
        • Hull University Teaching Hospitals NHS Trust
        • Contact:
          • Joanna Wieczorek, Dr
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • St James's University Hospital, Leeds Teaching Hospitals NHS Trust
        • Contact:
          • Nisha Sharma, Dr
      • London, United Kingdom, W1G 6AA
        • Recruiting
        • King Edward VII's Hospital, BARTS Health NHS Trust
        • Contact:
          • Tamara Suaris, Dr
      • Manchester, United Kingdom, M8 5RB
        • Recruiting
        • North Manchester General Hospital
        • Contact:
          • Alison Darlington, Dr
      • Manchester, United Kingdom, M23 9LT
        • Recruiting
        • Wythenshawe Hospital, Manchester University NHS Foundation Trust
        • Contact:
          • Gillian Hutchinson, Dr
      • Southend, United Kingdom, SS00RY
        • Not yet recruiting
        • Southend University Hospital
        • Contact:
          • Tania Mercado, Dr
      • Sutton, United Kingdom, SM2 5PT
        • Withdrawn
        • The Royal Marsden, The Royal Marsden NHS Foundation Trust
      • Truro, United Kingdom, TR13LJ
        • Withdrawn
        • Royal Cornwall Hospital
      • Wycombe, United Kingdom, HP11 2TT
        • Recruiting
        • High Wycombe Hospital
        • Contact:
          • Chin Lian NG, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women in screening and symptomatic clinics aged 18 years or older with breast masses scored as 1 of the following:

    • M3, M4 or M5 (mammographically uncertain, suspicious or highly suspicious of malignancy)
    • MRI5 (highly suspicious of malignancy on MRI)
    • U3, U4 or U5 (ultrasonically uncertain, suspicious or highly suspicious of malignancy)
    • have histologically proven breast cancer
  • who have ipsilateral axillary lymph nodes which are described as indeterminate or suspicious for metastatic disease and indicated for biopsy, as determined by individual breast unit criteria
  • are able to give informed consent for the study

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Open-tip pulsed needle biopsy

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).

Ultrasound-guided biopsy using 14G open-tip pulsed biopsy needle
Active Comparator: Conventional core needle biopsy (CNB)
Standard of care core needle biopsy used currently in clinics for biopsy procedures
Ultrasound-guided biopsy using standard of care core needle biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
After histopathological analysis of tissue samples, up to 1 week after biopsy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
1-14 days
Comparison of complication rates between the two techniques
Time Frame: 0-14 days post-biopsy
Collection of AE's, SAE's and device deficiencies
0-14 days post-biopsy
Comparison of the willingness of patients to undergo the procedure again if necessary
Time Frame: 4-14 days post-biopsy
Questionnaire administered to the participant on clinic visit for biopsy result
4-14 days post-biopsy
Comparison of number of tissue samples taken with the two techniques and the number of device insertions per subject
Time Frame: 1 day
Biopsy procedure data collected in real time
1 day
Comparison of the time taken for the two techniques (first biopsy device entry to last withdrawal)
Time Frame: 1 day
Biopsy procedure data collected in real time
1 day
Comparison of the total weight of tissue obtained with the two techniques and the average weight per device insertion
Time Frame: 1 day
Samples are weighed in clinic or pathology following the procedure
1 day
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
Yes/No, questionnaire given to radiologist
1 day
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
Yes/No, questionnaire given to radiologist
1 day
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
14-200 days
post-surgery
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
Biopsy procedure data
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Sarah Vinnicombe, Dr, Gloucestershire Hospitals NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2020

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

July 22, 2020

First Submitted That Met QC Criteria

July 31, 2020

First Posted (Actual)

August 5, 2020

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • NEODOC- 2021668610-221

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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