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Carbon Dye Tattooing of Biopsied Axillary Node in Breast Cancer

NCT03640819 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-10-14

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University Hospitals of Derby and Burton NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Amit Goyal, MS, MD, FRCS · Royal Derby Hospital, Derby, UK

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-27
Primary Completion
2019-07-31
Completion
2019-07-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03640819 on ClinicalTrials.gov