Application of Surgical Navigation System in Sentinel Lymph Node of Breast Cancer Research

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to compare the sentinel lymph node (SLN) detection rate of early breast cancer patients between using Indocyanine green (ICG) and Methylene blue with a novel surgical navigation system.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Sciences
• Collaborators: Affiliated Cancer Hospital of Shantou University Medical College; Cancer Hospital of Shantou University; Chinese PLA General Hospital; Yijishan Hospital of Wannan Medical College
• Treatments: Methylene Blue

Criteria

Inclusion criteria: (Before the test, all the subjects required for meeting the entry requirements before they join the group)

• female patients;

• The preoperative core needle biopsy or open surgical excision biopsy diagnosis as breast cancer;

• tumor diameter ≤ 3cm;

• No clinical examination of suspicious axillary lymph node-positive;

• diagnosed clinical conditions can be directly surgery as I, II breast cancer patients;

• preoperative clinical or radiologic evidence without distant metastases (M0);

• signed informed consent.

Exclusion criteria: (Before the test, the subjects under any one of items to meet the requirements can not be enrolled)

• Sentinel lymph node biopsy history had received surgery or axillary area;

• multi-center breast cancer or multiple lesions;

• clinical axillary lymph node metastasis have been found;

• mammary area had received neoadjuvant chemotherapy or radiotherapy;

• inflammatory breast cancer;

• pregnancy;

• no personal freedom and independent civil capacity.

Exclusion criteria: (trials, subjects necessary to meet the requirements of any one item, exit the clinical trial research.)

• severe allergic reaction occurs;

• persistent allergic reaction;

• subjects were required to withdraw from a clinical trial;

• researchers consider it not appropriate to continue to participate in the clinical trial investigator.