Trial | NCT02084784  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    98
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.
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 Started
Jan 31
2014
Primary Completion
Sep 30
2015
Study Completion
Sep 30
2015
Last Update
Jun 07
2018

Drug Indocyanine green

Subcutaneous injection around the areola with 2-4 points Indocyanine green with 1ml of 0.5%

  • Other names: ICG

Drug methylene blue

Subcutaneous injection around the areola with 2-4 points Methylene blue with 1ml of 1%

  • Other names: MB

Indocyanine green & methylene blue, Experimental

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

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.
No Results Posted