Clinical trial NCT03640819: Carbon Dye Tattooing of Biopsied Axillary Node in Breast Cancer
Official title: Pre-ATNEC - A Multicentre Prospective Feasibility Study of Carbon Dye Tattooing of Biopsied Axillary Node and Surgical Localisation in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sentinel Lymph Node
Breast Cancer
Tattoo; Pigmentation
Axilla; Breast
Lead sponsor: University Hospitals of Derby and Burton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Identification rate of tattooed node
timeFrame: 12 months
Secondary outcomes:
measure: Concordance of tattooed node and sentinel node
timeFrame: 12 months
measure: Migration of black dye into other nodes
timeFrame: 12 months
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
Study officials:
affiliation: Royal Derby Hospital, Derby, UK
name: Amit Goyal, MS, MD, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.