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

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ClinicalTrials.gov Identifier: NCT04500262
Recruitment Status : Unknown
Verified September 2020 by NeoDynamics AB.
Recruitment status was:  Recruiting
First Posted : August 5, 2020
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
NeoDynamics AB

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Device: Open-tip pulsed needle biopsy (NeoNavia Biopsy System) Device: Core needle biopsy (CNB) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison Trial of Open-tip Pulsed Needle Biopsy and Conventional Core Biopsy in Axillary Lymph Nodes
Actual Study Start Date : July 13, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Active Comparator: Open-tip pulsed needle biopsy Device: Open-tip pulsed needle biopsy (NeoNavia Biopsy System)
Ultrasound-guided biopsy using 14G open-tip pulsed biopsy needle

Active Comparator: Conventional core needle biopsy (CNB) Device: Core needle biopsy (CNB)
Ultrasound-guided biopsy using standard of care core needle biopsy




Primary Outcome Measures :
  1. • 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 af tissue samples, up to 1 week after biopsy ]

Secondary Outcome Measures :
  1. • Comparison of pain scores experienced during the needle biopsy procedure for the two biopsy techniques [ Time Frame: 1 day ]
    Pain questionnaire administered to the participant immediately following the procedure. Scale 0-10; 0 means no pain, 10 is the worst pain imaginable.

  2. • Comparison of complication rates between the two techniques [ Time Frame: 0-14 days post-biopsy ]
  3. • 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. • Comparison of pain scores experienced in the first three days after the biopsy for the two biopsy techniques [ Time Frame: 1-14 days post-biopsy ]
    Questionnaire administered to the participant on clinic visit for biopsy result. Scale 0-10; 0 means no pain, 10 is the worst pain imaginable

  5. • Comparison of procedure time for the two techniques (first biopsy device entry to last withdrawal) [ Time Frame: 1 day ]
  6. • Comparison of number of tissue samples taken with the two techniques and the number of device insertions per patient [ Time Frame: 1 day ]
  7. • Comparison of intended outcome of biopsy procedure, i.e. comparison of number of samples to be taken from respective lymph node with actual number of samples taken [ Time Frame: 1 day ]
  8. • Comparison of the weight of tissue obtained with the two techniques and the weight per device insertion [ Time Frame: after histopathological analysis af tissue samples, up to 1 week after biopsy ]
  9. • Radiologists' views on whether the pulse technology of the NeoNavia device facilitates accurate needle passage through the tissues to an optimum sampling position [ Time Frame: day 1 ]
    Yes/No, questionnaire given to radiologist

  10. • Radiologists' views on whether the pulse technology of the NeoNavia device facilitates stabilisation of the target and control of the needle position [ Time Frame: day 1 ]
    Yes/No, questionnaire given to radiologist

  11. • 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

  12. • Rate of patients screened but not enrolled due to exclusion criteria "Target lymph node not suitable for needle biopsy due to its close proximity to critical structures such as major blood vessels" [ Time Frame: time of screening ]
    1 day



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04500262


Contacts
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Contact: Kai-Uwe Schässburger, Ph.D. +46(0)8 522 79 664 kai-uwe.schassburger@neodynamics.com

Locations
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United Kingdom
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust Recruiting
Cambridge, United Kingdom, CB2 0QQ
Contact: Matthew Wallis, Dr         
University Hospital of Wales, Cardiff and Vale NHS Trust Not yet recruiting
Cardiff, United Kingdom, CF64 2XX
Contact: Philippa Young, Dr         
Western General Hospital, Lothian NHS Trust Not yet recruiting
Edinburgh, United Kingdom, EH4 2XU
Contact: Melanie Smith, Dr         
St James's University Hospital, Leeds Teaching Hospitals NHS Trust Not yet recruiting
Leeds, United Kingdom, LS9 7TF
Contact: Nisha Sharma, Dr         
King Edward VII's Hospital, BARTS Health NHS Trust Not yet recruiting
London, United Kingdom, W1G 6AA
Contact: Tamara Suaris, Dr         
King's College NHS Foundation Trust Not yet recruiting
London, United Kingdom, WC2R 2LS
Contact: Nikhil Patel, Dr         
Wythenshawe Hospital, Manchester University NHS Foundation Trust Recruiting
Manchester, United Kingdom, M23 9LT
Contact: Anthony Maxwell, Dr         
The Royal Marsden, The Royal Marsden NHS Foundation Trust Not yet recruiting
Sutton, United Kingdom, SM2 5PT
Contact: Steven Allen, Dr         
Sponsors and Collaborators
NeoDynamics AB
Investigators
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Principal Investigator: Anthony Maxwell, Dr Wythenshawe Hospital, Manchester University NHS Foundation Trust
Additional Information:
Publications:

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Responsible Party: NeoDynamics AB
ClinicalTrials.gov Identifier: NCT04500262    
Other Study ID Numbers: NEODOC- 2021668610-221
First Posted: August 5, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NeoDynamics AB:
Breast Cancer
Axillary Lymph Nodes
Biopsy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases