Clinical trial NCT02084784: Application of Surgical Navigation System in Sentinel Lymph Node of Breast Cancer Research
Official title: Study of Surgical Navigation System in Detection of Sentinel Lymph Node of Early Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sentinel Lymph Node
Breast Cancer
Keywords: Near-infrared fluorescence
Image guided surgery
Breast cancer;
Sentinel lymph node biopsy
Indocyanine green
Methylene blue
Lead sponsor: Chinese Academy of Sciences
Sponsor class: OTHER_GOV
Collaborators: name: Chinese PLA General Hospital
name: Affiliated Cancer Hospital of Shantou University Medical College
name: Wannan Medical College Yijishan Hospital
First posted: 2014-03-12
Enrollment: 98
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility 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.

Primary outcomes:
measure: Sentinel lymph node detection rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Key Laboratory of Molecular Imaging, Chinese Academy of Sciences
state: Beijing
Study officials:
affiliation: Chinese Academy of Sciences
name: Chongwei Chi, doctor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: He K, Zhou J, Yang F, Chi C, Li H, Mao Y, Hui B, Wang K, Tian J, Wang J. Near-infrared Intraoperative Imaging of Thoracic Sympathetic Nerves: From Preclinical Study to Clinical Trial. Theranostics. 2018 Jan 1;8(2):304-313. doi: 10.7150/thno.22369. eCollection 2018.
citation: He K, Chi C, Kou D, Huang W, Wu J, Wang Y, He L, Ye J, Mao Y, Zhang GJ, Wang J, Tian J. Comparison between the indocyanine green fluorescence and blue dye methods for sentinel lymph node biopsy using novel fluorescence image-guided resection equipment in different types of hospitals. Transl Res. 2016 Dec;178:74-80. doi: 10.1016/j.trsl.2016.07.010. Epub 2016 Jul 18.