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

Not Applicable

Completed

• Conditions: Sentinel Lymph Node; Breast Cancer
• Interventions: Drug: Indocyanine green; Drug: methylene blue

• Registration Number: NCT02084784
• Lead Sponsor: Chinese Academy of Sciences

Brief 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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-03-08
• Study First Submitted QC: 2014-03-10
• Study First Posted: 2014-03-12
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-05
• Last Update Posted: 2018-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 98

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Indocyanine green & methylene blue,	Indocyanine green	Subcutaneous injection around the areola with 2-4 points Methylene blue with 1ml of 1% Indocyanine green with 1ml of 0.5%
Indocyanine green & methylene blue,	methylene blue	Subcutaneous injection around the areola with 2-4 points Methylene blue with 1ml of 1% Indocyanine green with 1ml of 0.5%

Primary Outcome Measures

Name	Time	Method
Sentinel lymph node detection rate	1 year	Participants will be followed for the duration of hospital stay, an expected average of 1 year

Trial Locations

Locations (1)

Key Laboratory of Molecular Imaging, Chinese Academy of Sciences; 🇨🇳 Beijing, Beijing, China