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

NCT04500262 | Unknown

• 1 other identifier: NEODOC- 2021668610-221
• Study Type: interventional
• Target: 479
• Locations: 1 country
• Sites: 16

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Axillary Lymph Nodes; Biopsy

Outcome Measures

Primary Outcomes (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)

  After histopathological analysis of tissue samples, up to 1 week after biopsy

Secondary Outcomes (10)

• Comparison of pain scores for the two biopsy techniques immediately post-procedure and the maximum from days 1-3 post-procedure

  1-14 days

• Comparison of complication rates between the two techniques

  0-14 days post-biopsy

• Comparison of the willingness of patients to undergo the procedure again if necessary

  4-14 days post-biopsy

• Comparison of number of tissue samples taken with the two techniques and the number of device insertions per subject

  1 day

• Comparison of the time taken for the two techniques (first biopsy device entry to last withdrawal)

  1 day

Study Arms (2)

Open-tip pulsed needle biopsy

ACTIVE COMPARATOR

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).

Device: Open-tip pulsed needle biopsy (NeoNavia Biopsy System)

Conventional core needle biopsy (CNB)

ACTIVE COMPARATOR

Standard of care core needle biopsy used currently in clinics for biopsy procedures

Device: Core needle biopsy (CNB)

Interventions

Open-tip pulsed needle biopsy (NeoNavia Biopsy System) DEVICE

Ultrasound-guided biopsy using 14G open-tip pulsed biopsy needle

Open-tip pulsed needle biopsy

Core needle biopsy (CNB) DEVICE

Ultrasound-guided biopsy using standard of care core needle biopsy

Conventional core needle biopsy (CNB)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NeoDynamics AB: lead

Study Sites (16)

Basildon University Hospital

Basildon, SS16 5NL, United Kingdom

RECRUITING

Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

TERMINATED

Thirlestaine Breast Centre, Gloucestershire Hospitals NHS Foundation

Cheltenham, GL53 7AS, United Kingdom

RECRUITING

Darlington Memorial Hospital

Darlington, DL36HX, United Kingdom

RECRUITING

University Hospital of North Durham

Durham, DH1 5TW, United Kingdom

TERMINATED

Western General Hospital, Lothian NHS Trust

Edinburgh, EH4 2XU, United Kingdom

RECRUITING

Northwick Park Hospital

Harrow, HA1 3UJ, United Kingdom

RECRUITING

High Wycombe Hospital

High Wycombe, HP11 2TT, United Kingdom

RECRUITING

Hull University Teaching Hospitals NHS Trust

Hull, HU165JQ, United Kingdom

NOT YET RECRUITING

St James's University Hospital, Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

RECRUITING

King Edward VII's Hospital, BARTS Health NHS Trust

London, W1G 6AA, United Kingdom

RECRUITING

Wythenshawe Hospital, Manchester University NHS Foundation Trust

Manchester, M23 9LT, United Kingdom

RECRUITING

North Manchester General Hospital

Manchester, M8 5RB, United Kingdom

RECRUITING

Southend University Hospital

Southend, SS00RY, United Kingdom

NOT YET RECRUITING

The Royal Marsden, The Royal Marsden NHS Foundation Trust

Sutton, SM2 5PT, United Kingdom

WITHDRAWN

Royal Cornwall Hospital

Truro, TR13LJ, United Kingdom

WITHDRAWN

Related Publications (20)

• Houssami N, Turner RM. Staging the axilla in women with breast cancer: the utility of preoperative ultrasound-guided needle biopsy. Cancer Biol Med. 2014 Jun;11(2):69-77. doi: 10.7497/j.issn.2095-3941.2014.02.001.

  PMID: 25009748 BACKGROUND

• Topps AR, Barr SP, Pikoulas P, Pritchard SA, Maxwell AJ. Pre-operative Axillary Ultrasound-Guided Needle Sampling in Breast Cancer: Comparing the Sensitivity of Fine Needle Aspiration Cytology and Core Needle Biopsy. Ann Surg Oncol. 2018 Jan;25(1):148-153. doi: 10.1245/s10434-017-6090-1. Epub 2017 Oct 23.

  PMID: 29063297 BACKGROUND

• Britton PD, Provenzano E, Barter S, Gaskarth M, Goud A, Moyle P, Sinnatamby R, Wallis M, Benson JR, Forouhi P, Wishart GC. Ultrasound guided percutaneous axillary lymph node core biopsy: how often is the sentinel lymph node being biopsied? Breast. 2009 Feb;18(1):13-6. doi: 10.1016/j.breast.2008.09.003. Epub 2008 Nov 7.

  PMID: 18993074 BACKGROUND

• Macaskill EJ, Purdie CA, Jordan LB, Mclean D, Whelehan P, Brown DC, Evans A. Axillary lymph node core biopsy for breast cancer metastases -- how many needle passes are enough? Clin Radiol. 2012 May;67(5):417-9. doi: 10.1016/j.crad.2011.10.006. Epub 2011 Nov 26.

  PMID: 22119100 BACKGROUND

• Maxwell AJ, Bundred NJ, Harvey J, Hunt R, Morris J, Lim YY. A randomised pilot study comparing 13 G vacuum-assisted biopsy and conventional 14 G core needle biopsy of axillary lymph nodes in women with breast cancer. Clin Radiol. 2016 Jun;71(6):551-7. doi: 10.1016/j.crad.2016.02.024. Epub 2016 Mar 31.

  PMID: 27040801 BACKGROUND

• Giuliano AE, Hunt KK, Ballman KV, Beitsch PD, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, McCall LM, Morrow M. Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. JAMA. 2011 Feb 9;305(6):569-75. doi: 10.1001/jama.2011.90.

  PMID: 21304082 BACKGROUND

• POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer (POSNOC). ClinicaltrialsGov n.d. https://clinicaltrials.gov/ct2/show/NCT02401685 (accessed February 18, 2019)

  BACKGROUND

• Alvarez S, Anorbe E, Alcorta P, Lopez F, Alonso I, Cortes J. Role of sonography in the diagnosis of axillary lymph node metastases in breast cancer: a systematic review. AJR Am J Roentgenol. 2006 May;186(5):1342-8. doi: 10.2214/AJR.05.0936.

  PMID: 16632729 BACKGROUND

• Houssami N, Ciatto S, Turner RM, Cody HS 3rd, Macaskill P. Preoperative ultrasound-guided needle biopsy of axillary nodes in invasive breast cancer: meta-analysis of its accuracy and utility in staging the axilla. Ann Surg. 2011 Aug;254(2):243-51. doi: 10.1097/SLA.0b013e31821f1564.

  PMID: 21597359 BACKGROUND

• Joh JE, Han G, Kiluk JV, Laronga C, Khakpour N, Lee MC. Indications for axillary ultrasound use in breast cancer patients. Clin Breast Cancer. 2012 Dec;12(6):433-7. doi: 10.1016/j.clbc.2012.09.009. Epub 2012 Oct 11.

  PMID: 23062709 BACKGROUND

• Leenders MW, Broeders M, Croese C, Richir MC, Go HL, Langenhorst BL, Meijer S, Schreurs WH. Ultrasound and fine needle aspiration cytology of axillary lymph nodes in breast cancer. To do or not to do? Breast. 2012 Aug;21(4):578-83. doi: 10.1016/j.breast.2012.05.008. Epub 2012 Jun 19.

  PMID: 22717665 BACKGROUND

• Rattay T, Muttalib M, Khalifa E, Duncan A, Parker SJ. Clinical utility of routine pre-operative axillary ultrasound and fine needle aspiration cytology in patient selection for sentinel lymph node biopsy. Breast. 2012 Apr;21(2):210-4. doi: 10.1016/j.breast.2011.09.014. Epub 2011 Oct 5.

  PMID: 21981897 BACKGROUND

• Garcia-Ortega MJ, Benito MA, Vahamonde EF, Torres PR, Velasco AB, Paredes MM. Pretreatment axillary ultrasonography and core biopsy in patients with suspected breast cancer: diagnostic accuracy and impact on management. Eur J Radiol. 2011 Jul;79(1):64-72. doi: 10.1016/j.ejrad.2009.12.011. Epub 2010 Jan 4.

  PMID: 20047809 BACKGROUND

• Rao R, Lilley L, Andrews V, Radford L, Ulissey M. Axillary staging by percutaneous biopsy: sensitivity of fine-needle aspiration versus core needle biopsy. Ann Surg Oncol. 2009 May;16(5):1170-5. doi: 10.1245/s10434-009-0421-9. Epub 2009 Mar 5.

  PMID: 19263171 BACKGROUND

• Rautiainen S, Masarwah A, Sudah M, Sutela A, Pelkonen O, Joukainen S, Sironen R, Karja V, Vanninen R. Axillary lymph node biopsy in newly diagnosed invasive breast cancer: comparative accuracy of fine-needle aspiration biopsy versus core-needle biopsy. Radiology. 2013 Oct;269(1):54-60. doi: 10.1148/radiol.13122637. Epub 2013 Jun 14.

  PMID: 23771915 BACKGROUND

• Ganott MA, Zuley ML, Abrams GS, Lu AH, Kelly AE, Sumkin JH, Chivukula M, Carter G, Austin RM, Bandos AI. Ultrasound Guided Core Biopsy versus Fine Needle Aspiration for Evaluation of Axillary Lymphadenopathy in Patients with Breast Cancer. ISRN Oncol. 2014 Feb 4;2014:703160. doi: 10.1155/2014/703160. eCollection 2014.

  PMID: 24649373 BACKGROUND

• van Wely BJ, de Wilt JH, Francissen C, Teerenstra S, Strobbe LJ. Meta-analysis of ultrasound-guided biopsy of suspicious axillary lymph nodes in the selection of patients with extensive axillary tumour burden in breast cancer. Br J Surg. 2015 Feb;102(3):159-68. doi: 10.1002/bjs.9663. Epub 2014 Oct 29.

  PMID: 25354962 BACKGROUND

• Lee J, Bishop B, Allen S. NeoNavia biopsy system: Our experience of a new device for more precise ultrasound-guided percutaneous core biopsy of axillary lymph nodes. Breast Cancer Res 2017;19(suppl 1):18.

  BACKGROUND

• Abe H, Schmidt RA, Sennett CA, Shimauchi A, Newstead GM. US-guided core needle biopsy of axillary lymph nodes in patients with breast cancer: why and how to do it. Radiographics. 2007 Oct;27 Suppl 1:S91-9. doi: 10.1148/rg.27si075502.

  PMID: 18180238 BACKGROUND

• Abe H, Schmidt RA, Kulkarni K, Sennett CA, Mueller JS, Newstead GM. Axillary lymph nodes suspicious for breast cancer metastasis: sampling with US-guided 14-gauge core-needle biopsy--clinical experience in 100 patients. Radiology. 2009 Jan;250(1):41-9. doi: 10.1148/radiol.2493071483. Epub 2008 Oct 27.

  PMID: 18955508 BACKGROUND

Related Links

• Schässburger et al. High velocity pulse biopsy device enables controllable and precise needle insertion and high yield tissue acquisition. Phys Med. 2018 Feb;46:25-31. doi: 10.1016/j.ejmp.2017.12.014. Epub 2018 Jan 30.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biopsy, Large-Core Needle

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Officials

• Sarah Vinnicombe, Dr

  Gloucestershire Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai-Uwe Schässburger, Ph.D.

CONTACT

+46(0)8 522 79 664; kai-uwe.schassburger@neodynamics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: August 5, 2020
• Study Start: July 13, 2020
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2025
• Last Updated: June 1, 2023

Record last verified: 2023-05

Locations

GB (16)