Carbon Dye Tattooing of Biopsied Axillary Node in Breast Cancer

NCT03640819 | Completed

• 1 other identifier: 241379
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Identification rate of tattooed node

  Proportion of patients in whom tattooed node/s were identified.

  12 months

Secondary Outcomes (2)

• Concordance of tattooed node and sentinel node

  12 months

• Migration of black dye into other nodes

  12 months

Study Arms (1)

Tattooing of biopsied node

EXPERIMENTAL

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

Procedure: Tattooing of biopsied node

Interventions

Tattooing of biopsied node PROCEDURE

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.

Also known as: carbon dye (SPOT dye)

Tattooing of biopsied node

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not undergoing surgery or unfit for surgery

Sponsors & Collaborators

• University Hospitals of Derby and Burton NHS Foundation Trust: lead

Study Sites (1)

Royal Derby Hospital

Derby, DE22 3NE, United Kingdom

Location

Related Publications (2)

• 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. Breast Cancer Res Treat. 2021 Jan;185(2):433-440. doi: 10.1007/s10549-020-05961-3. Epub 2020 Oct 6.

  PMID: 33025481 RESULT

• Ditsch N, Rubio IT, Gasparri ML, de Boniface J, Kuehn T. Breast and axillary surgery in malignant breast disease: a review focused on literature of 2018 and 2019. Curr Opin Obstet Gynecol. 2020 Feb;32(1):91-99. doi: 10.1097/GCO.0000000000000593.

  PMID: 31833973 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Amit Goyal, MS, MD, FRCS

  Royal Derby Hospital, Derby, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 21, 2018
• Study Start: April 27, 2018
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

GB (1)