Methylene Blue Intradermal Injection for Sentinel Lymph Node Biopsy for Breast Cancer Patients
Breast Cancer Female, Early-Stage Breast Cancer, Sentinel Lymph Node
About this trial
This is an interventional treatment trial for Breast Cancer Female focused on measuring sentinel lymph node biopsy, methylene blue, intradermal injection, subcutaneous injection
Eligibility Criteria
Inclusion Criteria:
- who sign the informed consent form
- pathological diagnosed, without distant metastasis, early stage invasive breast cancer patients
- did not undergo neoadjuvant chemotherapy, endocrinotherapy or targeted therapy previously
- without breast and axillary surgery history
- Ejection fraction score in normal range accord to cardiac doppler
- Eastern Cooperative Oncology Group score ≤0-2
- axillary lymph node clinical negative
Exclusion Criteria:
- pregnancy
- any history of malignant tumor within five years
- diagnosis of multi-center, multi-focal or bilateral breast cancer
- history of breast tumor incision biopsy or vacuum-assisted biopsy
- methylene blue allergic
- appear with severe systematic disease or disfunction of any organ
Sites / Locations
- Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
methylene blue intradermal injection
methylene blue subcutaneous injection
For patients randomized to intradermal injection before surgery began, 0.5ml 0.4% methylene blue(1ml methylene blue mixed up with 1.5ml saline) would be injected sub-areola (12 o'clock , 3 o'clock , 6 o'clock , 9 o'clock) intradermally, 0.1ml respectively, or peritumoral depending on the tumor location, 10-15 minutes before skin incision. The breast was massaged for 5 minutes to facilitate the identification of blue lymphatic vessels and the lymph nodes.
For patients randomized to subcutaneous injection before surgery began, 0.5ml 100% methylene blue would be injected sub-areola subcutaneously(12 o'clock , 3 o'clock , 6 o'clock , 9 o'clock), 0.1ml respectively or peritumoral depending on the tumor location, 10-15 minutes before skin incision. The breast was massaged for 5 minutes to facilitate the identification of blue lymphatic vessels and the lymph nodes.