Carbon Dye Tattooing of Biopsied Axillary Node in Breast Cancer

Breast Cancer Clinical Trial

— pre-ATNEC  

Official title:

Pre-ATNEC - A Multicentre Prospective Feasibility Study of Carbon Dye Tattooing of Biopsied Axillary Node and Surgical Localisation in Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03640819
• Other study ID #: 241379
• Status: Completed
• Phase: N/A
• Start date: April 27, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: October 2020
• Source: University Hospitals of Derby and Burton NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Axilla; Breast
• Breast Cancer
• Breast Neoplasms
• Sentinel Lymph Node
• Tattoo; Pigmentation

Intervention

Procedure:
• Tattooing 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.

Locations

Country	Name	City	State
United Kingdom	Royal Derby Hospital	Derby

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals of Derby and Burton NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Goyal A, Puri S, Marshall A, Valassiadou K, Hoosein MM, Carmichael AR, Erdelyi G, Sharma N, Dunn J, York J. A multicentre prospective feasibility study of carbon dye tattooing of biopsied axillary node and surgical localisation in breast cancer patients. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification rate of tattooed node	Proportion of patients in whom tattooed node/s were identified.	12 months
Secondary	Concordance of tattooed node and sentinel node	Concordance rate: defined as the percent of patients in whomthe tattooed node is the sentinel node.	12 months
Secondary	Migration of black dye into other nodes	The number of black nodes at the time of sentinel node biopsy or axillary lymph node dissection.	12 months