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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Chinese PLA General Hospital
Cancer Hospital of Shantou University
Yijishan Hospital of Wannan Medical College
Information provided by (Responsible Party):
Chongwei Chi, Ph.D, Chinese Academy of Sciences
ClinicalTrials.gov Identifier:
NCT02084784
First received: March 8, 2014
Last updated: November 17, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention
Sentinel Lymph Node
Breast Cancer
Drug: Indocyanine green
Drug: methylene blue

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Surgical Navigation System in Detection of Sentinel Lymph Node of Early Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Sciences:

Primary Outcome Measures:
  • Sentinel lymph node detection rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Participants will be followed for the duration of hospital stay, an expected average of 1 year


Estimated Enrollment: 90
Study Start Date: June 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: ICG
Drug: methylene blue
Subcutaneous injection around the areola with 2-4 points Methylene blue with 1ml of 1%
Other Name: MB

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, we 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. We aim to show that the usage of our surgical navigation system with ICG to detect SLNs in breast cancer patients is technically feasible.
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02084784

Locations
China, Beijing
Key Laboratory of Molecular Imaging, Chinese Academy of Sciences
Beijing, Beijing, China, 100190
Sponsors and Collaborators
Chinese Academy of Sciences
Chinese PLA General Hospital
Cancer Hospital of Shantou University
Yijishan Hospital of Wannan Medical College
Investigators
Study Director: Chongwei Chi, doctor Key Laboratory of Molecular Imaging, Chinese Academy of Sciences
  More Information

Additional Information:
Publications:
Responsible Party: Chongwei Chi, Ph.D, Key Laboratory of Molecular Imaging, Chinese Academy of Sciences, Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT02084784     History of Changes
Other Study ID Numbers: 2011CB707700  973 
Study First Received: March 8, 2014
Last Updated: November 17, 2015
Health Authority: China: Food and Drug Administration

Keywords provided by Chinese Academy of Sciences:
Near-infrared fluorescence
Image guided surgery
Breast cancer;
Sentinel lymph node biopsy
Indocyanine green
Methylene blue

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 26, 2016