NCT05735795

Feasibility of Carbon-Dye Marking of Axillary Lymph Nodes Before Neoadjuvant Chemotherapy in Patients With Breast Cancer

Completed NA Last updated 24 August 2025

What this trial tests

NA trial testing Carbon Black Tattoo in Breast Cancer in 50 participants. Completed in 25 September 2024.

Timeline

7 February 2023

Primary endpoint
15 September 2024

25 September 2024

Quick facts

Lead sponsor	Gaziosmanpasa Research and Education Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	50
Start date	7 February 2023
Primary completion	15 September 2024
Estimated completion	25 September 2024
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Carbon Black Tattoo

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Gaziosmanpasa Research and Education Hospital

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Although treatment is started with surgery in early stage tumors depending on the molecular subtype, neoadjuvant chemotherapy is the initial treatment in locally advanced tumors or if axillary lymph node involvement is present.

Axillary lymph node dissection (ALND) has been used for a very long time in the traditional approach to the treatment of breast cancer. The current approach in patients with early stage, clinically negative breast cancer of the axilla is sentinel lymph node biopsy (SLNB). SLNB is done to evaluate the axilla in both early stage tumors and suitable patients after NAC. According to ACOSOG Z1071, when at least 3 lymph nodes were removed using lymphoscintigraphy and blue dye for SLNB, the false-negative rate was found to be less than 10% in patients with proven axillary involvement, and SLNB was shown to be feasible after NAC. Targeted axillary dissection (TAD) is a procedure that includes SLND with removal of the lymph node identified and marked as containing metastatic disease before treatment. Multiple clinical studies have shown that TAD is a viable option to reduce false-negativeness in patients with breast cancer after NAC. In patients with axillary involvement, a metallic clip is placed in the suspected lymph node prior to neoadjuvant therapy and a radioactive iodine-125 seed is implanted into the target after completion of chemotherapy, and during TAD, the core node is removed using a radioactive probe. Today, the applicability of these procedures is difficult due to both the cost and the absence of nuclear medicine units in some hospitals. For this reason, alternative methods that can be applied more easily in the evaluation of the axilla after NAC are being investigated. SPOT ENDOSCOPIC MARKER is an FDA (American Food and Drug Administration) approved Carbon Black Tattoo paint that has been used for a long time to mark lesions in the gastrointestinal tract. Its shelf life is 20 months. In our project, in patients with lymph node involvement in the axilla who have had a metallic clip placed with biopsy before NAC, the lymph node will be marked with a Spot Endoscopic Marker simultaneously, and the permanence of the spot marker dye will be evaluated by excising the clip-marked and black-painted lymph node in addition to the methylen blue injected during the operation. The reliability of the use of Spot Endoscopic Marker, which is much cheaper instead of clips, for permanent axillary marking in TAD will be evaluated.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.