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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02084784
• Other study ID #: 2011CB707700
• Secondary ID: 973
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: September 2015

Study information

• Verified date: June 2018
• Source: Chinese Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Sentinel Lymph Node

Intervention

Drug:
• Indocyanine green
Subcutaneous injection around the areola with 2-4 points Indocyanine green with 1ml of 0.5%
• methylene blue
Subcutaneous injection around the areola with 2-4 points Methylene blue with 1ml of 1%

Locations

Country	Name	City	State
China	Key Laboratory of Molecular Imaging, Chinese Academy of Sciences	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Chinese Academy of Sciences	Cancer Hospital of Shantou University, Chinese PLA General Hospital, Yijishan Hospital of Wannan Medical College

Country where clinical trial is conducted

China, 

References & Publications (1)

Chi C, Ye J, Ding H, He D, Huang W, Zhang GJ, Tian J. Use of indocyanine green for detecting the sentinel lymph node in breast cancer patients: from preclinical evaluation to clinical validation. PLoS One. 2013 Dec 16;8(12):e83927. doi: 10.1371/journal.po — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sentinel lymph node detection rate	Participants will be followed for the duration of hospital stay, an expected average of 1 year	1 year

External Links

•   A Website from Key Laboratory of Molecular Imaging, Chinese Academy of Sciences