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pre-ATNEC: Carbon Dye Tattooing of Biopsied Axillary Node in Breast Cancer

Sponsor
University Hospitals of Derby and Burton NHS Foundation Trust (Other)
Overall Status
Completed
CT.gov ID
NCT03640819
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
15.1
Actual Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Tattooing of biopsied node
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pre-ATNEC - A Multicentre Prospective Feasibility Study of Carbon Dye Tattooing of Biopsied Axillary Node and Surgical Localisation in Breast Cancer Patients
Actual Study Start Date :
Apr 27, 2018
Actual Primary Completion Date :
Jul 31, 2019
Actual Study Completion Date :
Jul 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.
Other Names:
  • carbon dye (SPOT dye)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Identification rate of tattooed node [12 months]

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

    Secondary Outcome Measures

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Royal Derby Hospital Derby United Kingdom DE22 3NE

    Sponsors and Collaborators

    • University Hospitals of Derby and Burton NHS Foundation Trust

    Investigators

    • Principal Investigator: Amit Goyal, MS, MD, FRCS, Royal Derby Hospital, Derby, UK

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Amit Goyal, Associate Professor, University Hospitals of Derby and Burton NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT03640819
    Other Study ID Numbers:
    • 241379
    First Posted:
    Aug 21, 2018
    Last Update Posted:
    Oct 14, 2020
    Last Verified:
    Oct 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Oct 14, 2020