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

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

NCT ID: NCT05735795

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
breast cancer
Lymph node metastasis
Targeted axillary dissection
Nodal marking

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Prospective cohort study

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Carbon Black Tattoo
Description: 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.
Arm group label: Carbon Black Tattoo arm

Summary: 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.

Detailed description: Breast cancer affects millions of women worldwide. According to the statistics, 2.3 million new cases of breast cancer were reported in 2020. 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. With NAC in locally advanced breast cancer, it is possible to both shrink the tumor and make patients who were initially inoperable suitable for surgery, and increase the feasibility of breast-conserving surgery. Although 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. The procedure is performed with SLND using the dual-tracer technique. 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Patients with locally advanced breast cancer known to have metastases to the axillary lymph nodes at baseline and referred for neoadjuvant chemotherapy will be included in the study. Exclusion Criteria: - diagnosis by excisional biopsy - previous axillary surgery - failure to complete neoadjuvant therapy - progression during therapy.

Gender: Female

Gender based: Yes

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Gaziosmanpasa Training and Research Hospital

Address:
City: Istanbul
Zip: 34000
Country: Turkey

Status: Recruiting

Contact:
Last name: Emine Yildirim, Assoc. Prof.

Phone: 00905056234825
Email: opdreyildirim@gmail.com

Investigator:
Last name: Nese Ucar, MD
Email: Sub-Investigator

Investigator:
Last name: Sibel Bektas, Prof.
Email: Sub-Investigator

Start date: February 7, 2023

Completion date: March 30, 2024

Lead sponsor:
Agency: Gaziosmanpasa Research and Education Hospital
Agency class: Other

Source: Gaziosmanpasa Research and Education Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05735795