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

June 5, 2018 updated by: Chongwei Chi, Ph.D, Chinese Academy of Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100190
        • Key Laboratory of Molecular Imaging, Chinese Academy of Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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%
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sentinel lymph node detection rate
Time Frame: 1 year
Participants will be followed for the duration of hospital stay, an expected average of 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Sciences

Collaborators

Chinese PLA General Hospital
Affiliated Cancer Hospital of Shantou University Medical College
Yijishan Hospital of Wannan Medical College

Investigators

  • Study Director: Chongwei Chi, doctor, Chinese Academy of Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2014

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

March 8, 2014

First Submitted That Met QC Criteria

March 10, 2014

First Posted (ESTIMATE)

March 12, 2014

Study Record Updates

Last Update Posted (ACTUAL)

June 7, 2018

Last Update Submitted That Met QC Criteria

June 5, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011CB707700
  • 973 (2011CB707700)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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