Topic: Cancer
Conditions
Interventions
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 on
Sponsors
University Hospital of South Manchester NHS Foundation Trust (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of women who would be willing to undergo the biopsy again.; Timepoint(s): 4 to 14 days post-biopsy | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Outcome results
None listed