Application of Preoperative Axillary Lymph Node Marking With Nano-Carbon in Breast Cancer Patients Before Neoadjuvant Chemotherapy

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).

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Neoadjuvant Therapy; Sentinel Lymph Node Biopsy
• Intervention / Treatment: Drug: carbon dye

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chuan Wang; Phone Number: 13365910252; Email: chuanwang1968@outlook.com
• Study Contact Backup: Name: Minyan Chen; Phone Number: 15980278832; Email: 15980278832@163.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Study Officials
      • Contact: Chuan Wang; Phone Number: 13365910252; Email: chuanwang1968@outlook.com
      • Contact: Minyan Chen; Phone Number: 15980278832; Email: 15980278832@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Female; 2. Aged >=18 years; 3. With invasive breast cancer; 4. Patients to be treated with neoadjuvant chemotherapy; 5. Patients scheduled to undergo routine fine needle aspiration (FNA) or core biopsy of abnormal axillary lymph node; 6. Patients with operable breast cancer; 7. Heart, lung, liver and kidney function well, suitable for patients undergoing surgery; 8. Informed consent patients.

Exclusion Criteria:

• 1. Patients who do not plan or are unable to operate; 2. Patients with distant metastasis were excluded; 3. Patients without invasive cancer components in DCIS alone; 4. Patients who are unable to cooperate with the doctor's recommended surgical treatment (breast conserving surgery or radical surgery) due to personal or family factors; 5. Patients with serious cardiopulmonary diseases, uncontrolled infectious diseases and other non tumor related diseases who can not tolerate comprehensive treatment such as surgery and chemotherapy; 6. Patients with mental illness or other reasons unable to sign informed consent; 7. Patients with poor medical compliance who cannot complete the trial treatment process and follow-up according to the standard according to the researcher's opinion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Experimental: Tattooing of biopsied node; Prior to NST, suspicious axillary lymph nodes were biopsied by core needle or fne needle aspiration. The largest and/or biopsy-confrmed metastastic node was then injected with highly purifed carbon suspension either at the time of biopsy or at a separate session.

Drug: carbon dye; Tattooing (marking) of biopsied node with carbon dye at the time or at a separate session 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification rate of tattooed node	Proportion of patients in whom tattooed node/s were identified.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Migration of black dye into other nodes	The number of black nodes at the time of sentinel node biopsy or axillary lymph node dissection.	12 months
Concordance of tattooed node and sentinel node	Concordance rate: defined as the percent of patients in whomthe tattooed nodeis the sentinel node.	12 months

Collaborators and Investigators

• Sponsor: Fujian Medical University Union Hospital
• Investigators: Principal Investigator: China Fujian, Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (Actual): August 23, 2022

Study Record Updates

• Last Update Posted (Actual): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: BC-TATOO-2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No