Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Contact information



Primary contact

Miss Tania Cutts


Contact details

University of Manchester
Nightingale Centre
Southmoor Road
M23 9LT
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A feasibility study comparing the safety and acceptability of vacuum-assisted biopsy and conventional 14-gauge core biopsy in the diagnosis of ultrasonically indeterminate and abnormal axillary lymph nodes


Study hypothesis

Women with invasive breast cancer undergo ultrasound of the axilla (armpit) before surgery to detect spread of disease (metastases) to the lymph nodes. If this is normal the woman undergoes operative sentinel lymph node biopsy (SLNB), usually at the same time as surgery to the breast. If the SLNB is positive the woman undergoes axillary node clearance at a subsequent operation.

Abnormal axillary lymph nodes on ultrasound undergo needle sampling. If metastases are confirmed the woman undergoes node clearance at the same operation as surgery to the breast. The number of women who need to undergo more than one operation can be minimised by maximising the number of women with axillary metastatic disease who are diagnosed before surgery.

Ultrasound has a sensitivity of ~60% for the detection of metastatic lymph nodes. Ultrasound-guided biopsy of nodes that contain metastases has a sensitivity of ~80%. This is less than 100% because the needle may miss the part of the lymph node containing the tumour deposit. Increasing the volume of tissue removed may increase accuracy.

Vacuum-assisted biopsy (VAB) is a needle technique performed under local anaesthetic which allows more tissue to be removed than with a standard needle. Repeated samples can be taken with a single needle insertion, allowing large numbers of samples to be quickly taken. VAB of breast abnormalities is well tolerated by patients.

This study will determine whether the use of VAB in the axilla is safe and acceptable to patients and whether a larger randomised study comparing the two techniques is feasible. The results will inform the design of a larger study which will determine whether VAB significantly increases the preoperative diagnosis rate of axillary metastatic disease. If it does, its use will result in a reduction in the number of second operations in women with breast cancer.

Ethics approval


Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Topic: Cancer; Subtopic: Breast Cancer; Disease: Breast


Participants randomised to have axillary lymph node biopsy with either 14-gauge core needle biopsy device or a 13-gauge or 10-gauge vacuum biopsy device.

Study Entry : Registration only

Intervention type



Not Applicable

Drug names

Primary outcome measure

Proportion of women who would be willing to undergo the biopsy again.; Timepoint(s): 4 to 14 days post-biopsy

Secondary outcome measures

1. Procedure pain scores; Timepoint(s): Immediate and at 4-14 days post-biopsy
2. Proportion of women approached who are willing to enter the study.; Timepoint(s): AT recruitment
3. The sensitivity of vacuum biopsy relative to conventional core biopsy (preliminary data only); Timepoint(s): Following surgery

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Women in screening and symptomatic clinics aged >35 years with breast masses scored as:
1.1. M4 or M5 (mammographically suspicious or highly suspicious of malignancy) and U5 (ultrasonically highly suspicious of malignancy)
1.2. and/or MRI5 (highly suspicious of malignancy on MRI) and U5
1.3. and/or have histologically proven breast cancer
1.4. and who have ultrasonically indeterminate or abnormal ipsilateral axillary lymph nodes (i.e. suspicious of metastatic disease)
2. Indeterminate / abnormal lymph nodes are defined as those with >2.3mm lymphoid thickness and/or focal cortical bulging and/or non-hilar blood flow and/or loss or reduction in the normal hilar fat

Participant type


Age group




Target number of participants

Planned Sample Size: 80; UK Sample Size: 80

Total final enrolment


Participant exclusion criteria

1. Women who are on anticoagulants or have known clotting disorders
2. Previous ipsilateral axillary surgery
3. Target lymph node not suitable for vacuum biopsy due to its proximity to critical structures such as major blood vessels

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Manchester
M23 9LT
United Kingdom

Sponsor information


University Hospital of South Manchester NHS Foundation Trust (UK)

Sponsor details

Wythenshawe Hospital
Southmoor Road
M23 9LT
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

British Society of Breast Radiology (BSBR) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2016 results in: (added 11/07/2019)

Publication citations

Additional files

Editorial Notes

11/07/2019: Publication reference and total final enrolment added. 29/03/2017: No publications found, verifying study status with principal investigator.