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

March 8, 2014
November 17, 2015
June 2013
December 2016   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT02084784 on ClinicalTrials.gov Archive Site
Not Provided
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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
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, 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.
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Sentinel Lymph Node
  • Breast Cancer
  • 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
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%
Interventions:
  • Drug: Indocyanine green
  • Drug: methylene blue
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.pone.0083927. eCollection 2013.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
90
December 2016
December 2016   (final data collection date for primary outcome measure)

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.
Female
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No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT02084784
2011CB707700, 973
Yes
Not Provided
Not Provided
Chongwei Chi, Ph.D, Chinese Academy of Sciences
Chinese Academy of Sciences
  • Chinese PLA General Hospital
  • Cancer Hospital of Shantou University
  • Yijishan Hospital of Wannan Medical College
Study Director: Chongwei Chi, doctor Key Laboratory of Molecular Imaging, Chinese Academy of Sciences
Chinese Academy of Sciences
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP