Condition category
Cancer
Date applied
12/06/2014
Date assigned
12/06/2014
Last edited
10/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Miss Tania Cutts

ORCID ID

Contact details

University of Manchester
Nightingale Centre
Southmoor Road
Manchester
M23 9LT
United Kingdom
tania.cutts@uhsm.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14676

Study information

Scientific title

Acronym

Vacuum-assisted and conventional core biopsy of 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

13/NW/0326

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Intervention

Axillary lymph node biopsy: 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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

20/06/2013

Overall trial end date

17/06/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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 MRI) and U5
- and/or have histologically proven breast cancer
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

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 80; UK Sample Size: 80

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

20/06/2013

Recruitment end date

17/06/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Manchester
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

University Hospital of South Manchester NHS Foundation Trust (UK)

Sponsor details

Wythenshawe Hospital
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

British Society of Breast Radiology (BSBR) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes