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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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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

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Sentinel Lymph Node Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Indocyanine green & methylene blue,

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

Group Type EXPERIMENTAL

Indocyanine green

Intervention Type DRUG

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

methylene blue

Intervention Type DRUG

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

Interventions

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Indocyanine green

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

Intervention Type DRUG

methylene blue

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

Intervention Type DRUG

Other Intervention Names

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ICG MB

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.

* 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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No