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

NCT05512468 | Unknown

• 1 other identifier: BC-TATOO-2020
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer; Neoadjuvant Therapy; Sentinel Lymph Node Biopsy

Outcome Measures

Primary Outcomes (1)

• Identification rate of tattooed node

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

  12 months

Secondary Outcomes (2)

• Concordance of tattooed node and sentinel node

  12 months

• Migration of black dye into other nodes

  12 months

Study Arms (1)

Experimental: Tattooing of biopsied node

OTHER

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

Interventions

carbon dye DRUG

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.

Experimental: Tattooing of biopsied node

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Study Officials

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• China Fujian

  Fujian Medical University Union Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chuan Wang

CONTACT

13365910252; chuanwang1968@outlook.com

Minyan Chen

CONTACT

15980278832; 15980278832@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 23, 2022
• Study Start: March 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: August 23, 2022

Record last verified: 2022-08

Locations

CN (1)