Breast Cancer, Sentinel Lymph Node
Conditions
Keywords
Near-infrared fluorescence, Image guided surgery, Breast cancer;, Sentinel lymph node biopsy, Indocyanine green, Methylene blue
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.
Interventions
DRUGIndocyanine green
Subcutaneous injection around the areola with 2-4 points Indocyanine green with 1ml of 0.5%
DRUGmethylene blue
Subcutaneous injection around the areola with 2-4 points Methylene blue with 1ml of 1%
Sponsors
Chinese PLA General Hospital
Affiliated Cancer Hospital of Shantou University Medical College
Wannan Medical College Yijishan Hospital
Chinese Academy of Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sentinel lymph node detection rate | 1 year | Participants will be followed for the duration of hospital stay, an expected average of 1 year |
Countries
China
Outcome results
None listed