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: March 24, 2014
Last verified: March 2014
  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
Detection Rate
Sentinel Lymph Node
Breast Cancer
Indocyanine Green.
Methylene Blue
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: August 2014
Estimated Primary Completion Date: June 2014 (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 Drug: methylene blue

  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: March 24, 2014
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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014