Axilla; Breast, Breast Cancer, Sentinel Lymph Node, Tattoo; Pigmentation
Conditions
Brief summary
The primary aim of this prospective, multicentre study is to determine whether the involved node can be marked using black carbon dye and successfully identified at the time of surgery. The secondary aims are to determine the concordance between the tattooed node and sentinel node, migration of black dye into other nodes, and false-negative rate of tattooed node (in patients undergoing ALND after NACT).
Detailed description
Pretreatment evaluation of axillary lymph nodes and marking of biopsied nodes in patients with newly diagnosed breast cancer is becoming routine practice. Tagging of biopsied axillary lymph nodes with metal markers, similar to what is done for suspicious breast lesions, is being adopted in clinical practice. The need to mark a positive axillary lymph node becomes especially relevant in cases where neoadjuvant chemotherapy (NACT) is anticipated so that these nodes may be identified at the time of surgery. Measures that improve both the accuracy of nodal evaluation after NACT and the ability to assess treatment response are desirable in order to tailor therapies for breast cancer treatment. The investigators sought to test tattooing of biopsied axillary lymph nodes with a sterile black carbon suspension (Spot dye). The concept is based on the experience in the gastrointestinal tract wherein tattooing is widely used for marking lesions or tumours biopsied during endoscopy. India ink tattoos of colonic lesions remain identifiable over a long period of time. Spot is routinely used in the UK for tattooing gastrointestinal tract lesions and is used to mark the axillary lymph nodes in breast cancer by some centres in the US and Europe. The intraoperative success of identifying tattooed axillary lymph nodes and their concordance to sentinel nodes will be determined.
Interventions
PROCEDURETattooing of biopsied node
Tattooing (marking) of biopsied node with carbon dye (SPOT dye) at the time of fine needle aspiration or core biopsy or separate visit under ultrasound guidance. The dye will be injected in the cortex of the node and the perinodal tissue under ultrasound guidance. Patients will undergo standard (routine) armpit surgery and may receive neoadjuvant chemotherapy as planned by the clinical team. This could be removal of a few lymph glands (sentinel node biopsy) or removal of all the lymph glands (axillary lymph node dissection) in the armpit. The surgeon will try to identify and remove the tattooed lymph gland at the time of planned armpit surgery.
Sponsors
University Hospitals of Derby and Burton NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 * Male or female * Patients scheduled to undergo routine fine needle aspiration (FNA) or core biopsy of abnormal axillary lymph node * Invasive breast cancer * Written informed consent for the study
Exclusion criteria
* Not undergoing surgery or unfit for surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification rate of tattooed node | 12 months | Proportion of patients in whom tattooed node/s were identified. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concordance of tattooed node and sentinel node | 12 months | Concordance rate: defined as the percent of patients in whomthe tattooed node is the sentinel node. |
| Migration of black dye into other nodes | 12 months | The number of black nodes at the time of sentinel node biopsy or axillary lymph node dissection. |
Countries
United Kingdom
Outcome results
None listed