NCT02084784

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

Study of Surgical Navigation System in Detection of Sentinel Lymph Node of Early Breast Cancer Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Chinese Academy of Sciences · Other Government
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

Assessment of the sentinel lymph node (SLN) in patients with early stage breast cancer is vital in selecting the appropriate surgical approach. However, the existing methods, including methylene blue and nuclides, possess low efficiency and effectiveness in mapping SLNs, and to a certain extent exert side effects during application. Indocyanine green (ICG), as a fluorescent dye, has been proved reliable usage in SLN detection by several other groups. In this paper, the investigators introduce a novel surgical navigation system to detect SLN with ICG. This system contains two charge-coupled devices (CCD) to simultaneously capture real-time color and fluorescent video images through two different bands. During surgery, surgeons only need to follow the fluorescence display. In addition, the system saves data automatically during surgery enabling surgeons to find the registration point easily according to image recognition algorithms. The investigators aim to show that the usage of our surgical navigation system with ICG to detect SLNs in breast cancer patients is technically feasible.

Conditions

• Sentinel Lymph Node
• Breast Cancer

Interventions

Type	Name	Description
DRUG	Indocyanine green	Subcutaneous injection around the areola with 2-4 points Indocyanine green with 1ml of 0.5%
DRUG	methylene blue	Subcutaneous injection around the areola with 2-4 points Methylene blue with 1ml of 1%

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2014-03-12
• Last updated: 2018-06-07

Locations

1 site across 1 country: China