Breast CancerCOMPULSENCT04500262
Comparison Trial of Open-tip Pulsed Needle Biopsy and Conventional Core Biopsy in Axillary Lymph Nodes
A study testing Open-tip pulsed needle biopsy (NeoNavia Biopsy System) and Core needle biopsy (CNB) in people with Breast Cancer, run by NeoDynamics AB at 16 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Open-tip pulsed needle biopsy (NeoNavia Biopsy System) and Core needle biopsy (CNB)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 479 participants
- Where
- 16 sitesUnited Kingdom
- Study dates
- 13 Jul 2020to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United Kingdom16 sites, 12 recruiting
- Recruiting
Basildon University Hospital
Basildon, SS16 5NL
Jessica Eades
- Terminated
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
- Recruiting
Thirlestaine Breast Centre, Gloucestershire Hospitals NHS Foundation
Cheltenham, GL53 7AS
Sarah Vinnicombe, Dr
- Recruiting
Darlington Memorial Hospital
Darlington, DL36HX
Bob Kent
- Terminated
University Hospital of North Durham
Durham, DH1 5TW
- Recruiting
Western General Hospital, Lothian NHS Trust
Edinburgh, EH4 2XU
Melanie Smith, Dr
- Recruiting
Northwick Park Hospital
Harrow, HA1 3UJ
Mia Morgan, Dr
- Recruiting
High Wycombe Hospital
High Wycombe, HP11 2TT
Chin Lian NG, Dr
- Not yet recruiting
Hull University Teaching Hospitals NHS Trust
Hull, HU165JQ
Joanna Wieczorek, Dr
- Recruiting
St James's University Hospital, Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
Nisha Sharma, Dr
- Recruiting
King Edward VII's Hospital, BARTS Health NHS Trust
London, W1G 6AA
Tamara Suaris, Dr
- Recruiting
Wythenshawe Hospital, Manchester University NHS Foundation Trust
Manchester, M23 9LT
Gillian Hutchinson, Dr
- Recruiting
North Manchester General Hospital
Manchester, M8 5RB
Alison Darlington, Dr
- Not yet recruiting
Southend University Hospital
Southend, SS00RY
Tania Mercado, Dr
- Withdrawn
The Royal Marsden, The Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT
- Withdrawn
Royal Cornwall Hospital
Truro, TR13LJ
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Open-tip pulsed needle biopsy (NeoNavia Biopsy System), Core needle biopsy (CNB)
- Keywords
- Breast Cancer, Axillary Lymph Nodes, Biopsy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open-tip pulsed needle biopsy (NeoNavia Biopsy System)Device
Ultrasound-guided biopsy using 14G open-tip pulsed biopsy needle
Core needle biopsy (CNB)Device
Ultrasound-guided biopsy using standard of care core needle biopsy
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 Receives: Device: Core needle biopsy (CNB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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.
Measured: 1-14 days
Comparison of complication rates between the two techniques
Collection of AE's, SAE's and device deficiencies
Measured: 0-14 days post-biopsy
Comparison of the willingness of patients to undergo the procedure again if necessary
Questionnaire administered to the participant on clinic visit for biopsy result
Measured: 4-14 days post-biopsy
Comparison of number of tissue samples taken with the two techniques and the number of device insertions per subject
Biopsy procedure data collected in real time
Measured: 1 day
Comparison of the time taken for the two techniques (first biopsy device entry to last withdrawal)
Biopsy procedure data collected in real time
Measured: 1 day
Comparison of the total weight of tissue obtained with the two techniques and the average weight per device insertion
Samples are weighed in clinic or pathology following the procedure
Measured: 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
Yes/No, questionnaire given to radiologist
Measured: 1 day
Users views upon whether the pulse technology of the NeoNavia® device facilitates stabilisation of the target and control of the needle position
Yes/No, questionnaire given to radiologist
Measured: 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).
14-200 days
Measured: post-surgery
Comparison of intended outcome of biopsy procedure, i.e. number of samples to be taken from respective lymph node, and actual outcome
Biopsy procedure data
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start13 Jul 2020
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 479 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeoDynamics AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Vinnicombe, Dr, Principal investigator, Gloucestershire Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500262
- Sponsor's protocol ID
- NEODOC- 2021668610-221
- Acronym
- COMPULSE
- Status last verified
- May 2023
- First submitted
- 22 Jul 2020
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25009748Topps 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.
PubMed 29063297Britton 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.
PubMed 18993074Macaskill 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.
PubMed 22119100Maxwell 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.
PubMed 27040801Giuliano 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.
PubMed 21304082POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer (POSNOC). ClinicaltrialsGov n.d. https://clinicaltrials.gov/ct2/show/NCT02401685 (accessed February 18, 2019)
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.
PubMed 16632729Houssami 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.
PubMed 21597359Joh 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.
PubMed 23062709Leenders 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.
PubMed 22717665Rattay 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.
PubMed 21981897Garcia-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.
PubMed 20047809Rao 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.
PubMed 19263171Rautiainen 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.
PubMed 23771915
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Trial of Open-tip Pulsed Needle Biopsy and Conventional Core Biopsy in Axillary Lymph Nodes
- ClinicalTrials.gov ID
- NCT04500262
- Acronym / sponsor ID
- COMPULSE / NEODOC- 2021668610-221
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Axillary Lymph Nodes, Biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 479 participants (estimated)
- Lead sponsor
- NeoDynamics ABIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open-tip pulsed needle biopsy | Active comparator | Device: Open-tip pulsed needle biopsy (NeoNavia Biopsy System)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). |
| Conventional core needle biopsy (CNB) | Active comparator | Device: Core needle biopsy (CNB)Standard of care core needle biopsy used currently in clinics for biopsy procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women in screening and symptomatic clinics aged 18 years or older with breast masses scored as 1 of the following:
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open-tip pulsed needle biopsy (NeoNavia Biopsy System)Ultrasound-guided biopsy using 14G open-tip pulsed biopsy needle | Device | Open-tip pulsed needle biopsy |
| Core needle biopsy (CNB)Ultrasound-guided biopsy using standard of care core needle biopsy | Device | Conventional core needle biopsy (CNB) |
Primary outcome
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
10 secondary outcomes
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
Comparison of complication rates between the two techniques
Time frame: 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
Comparison of number of tissue samples taken with the two techniques and the number of device insertions per subject
Time frame: 1 day
Comparison of the time taken for the two techniques (first biopsy device entry to last withdrawal)
Time frame: 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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Background: PubMed 25009748Houssami 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.
- Background: PubMed 29063297Topps 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.
- Background: PubMed 18993074Britton 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.
- Background: PubMed 22119100Macaskill 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.
- Background: PubMed 27040801Maxwell 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.
- Background: PubMed 21304082Giuliano 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.
- BackgroundPOSNOC - 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: PubMed 16632729Alvarez 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.
- Background: PubMed 21597359Houssami 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.
- Background: PubMed 23062709Joh 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.
- Background: PubMed 22717665Leenders 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.
- Background: PubMed 21981897Rattay 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.
- 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.Link provided by the sponsor.
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A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Vinnicombe, Dr principal investigator
Gloucestershire Hospitals NHS Foundation Trust
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open-tip pulsed needle biopsy (NeoNavia Biopsy System) and Core needle biopsy (CNB) in people with Breast Cancer, run by NeoDynamics AB at 16 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai-Uwe Schässburger, Ph.D. (+46(0)8 522 79 664, kai-uwe.schassburger@neodynamics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04500262, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.