Early-stage breast cancer sentinel lymph node tracing
Conditions
Interventions
treatment group:Isosulfan Blue Injection
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The subjects fully understood the purpose, nature and methods of the trial, voluntarily agreed to participate, and signed the informed consent form; 2. Age range: 18 to 70 years old (inclusive); gender not restricted; 3. Diagnosed by histopathology as invasive breast cancer or carcinoma in situ, with negative clinical axillary lymph nodes, and being an early-stage breast cancer patient; 4. Clinically evaluated as having a TNM stage of cT1-2N0M0 in the early-stage breast cancer; 5. No history of radiation therapy for the breast on the chest wall; 6. No clear surgical contraindications identified in the routine preoperative examinations; 7. The subjects can maintain good communication with the researchers and understand and comply with all the requirements of this clinical trial.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to the test drug and its excipients, or to triphenylmethane or related compounds, or to other dyes, or who have a history of allergies to two or more drugs, foods, etc.; 2. Those with a previous history of bronchial asthma, allergies, etc.; 3. Those whose axillary lymph nodes are positive after puncture examination in the clinical assessment; 4. Those with metastatic cancer or abnormal lymph node enlargement as indicated by clinical or radiological evidence; 5. Those who have previously undergone breast cancer surgery and neoadjuvant chemotherapy on the affected side; 6. Those who have undergone any form of breast augmentation surgery before; 7. Those with severe or uncontrollable diseases: such as severe cardiovascular and cerebrovascular diseases (hematological diseases, chronic congestive heart failure with NYHA classification >= III, etc.), severe pulmonary insufficiency, patients with mental illness, etc.; 8. Those with liver or kidney dysfunction, that is, alanine aminotransferase, aspartate aminotransferase > 2.5 times the upper limit of normal value, total bilirubin > 1.5 times the upper limit of normal value and/or serum creatinine > 1.5 times the upper limit of normal value, or those whose researchers consider that the liver and/or kidneys have been damaged to the extent that they should not participate in this study; 9. Those who have had a severe injury or surgical history that the researcher considers to affect the efficacy and safety of the test drug within 3 months before screening; 10. Pregnant or lactating patients, or those who have a pregnancy plan from the screening period to 3 months after administration and are unwilling to take effective contraceptive measures or have an egg donation plan; 11. Those with positive results for any of the following screening indicators for infectious diseases (hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and HIV antibody); 12. Those who have participated in any other clinical trials within the past 3 months; 13. Those whose researchers consider that the subject has any other conditions that do not meet the inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of sentinel lymph node tracing; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of lymphatic vessel tracing;The accuracy rate of sentinel lymph node tracing; | — |
Countries
China
Contacts
Public ContactWang Shu
Peking University People's Hospital
Outcome results
None listed