Plain English Summary
Trial website
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
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
Acronym
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
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Cancer; Subtopic: Breast Cancer; Disease: Breast
Intervention
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 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
20/06/2013
Overall trial end date
17/06/2014
Reason abandoned (if study stopped)
Eligibility
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
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
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
Basic results (scientific)
Publication list