Carbon Dye Tattooing of Biopsied Axillary Node in Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer; Sentinel Lymph Node; Tattoo; Pigmentation; Axilla; Breast
• Interventions: Procedure: Tattooing of biopsied node

• Registration Number: NCT03640819
• Lead Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust

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.

Study Timeline

• Study Start: 2018-04-27
• Study First Submitted: 2018-08-15
• Study First Submitted QC: 2018-08-17
• Study First Posted: 2018-08-21
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-10
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tattooing of biopsied node	Tattooing of biopsied node	The biopsied node will be tattooed at the time of needle biopsy (fine needle aspiration or core biopsy) or separate visit under ultrasound guidance.

Primary Outcome Measures

Name	Time	Method
Identification rate of tattooed node	12 months	Proportion of patients in whom tattooed node/s were identified.

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Royal Derby Hospital; 🇬🇧 Derby, United Kingdom