Breast cancer
Conditions
Interventions
different dose groups:HSA-ICG
Sponsors
Xiang’an Hosipital of Xiamen University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Females aged >= 18 years. 2. Confirmed diagnosis of breast cancer by means of histology or cytology and eligible for breast cancer surgery. 3. Tumor size >= 5 mm (0, 5 cm) diameter according to anatomical imaging data. 4. WHO performance score 0-2. 5. Life expectancy greater than 12 weeks. 6. The function of liver and kidney are normal. 7. Written informed consent has been obtained,and patient is able and willing to comply with all trial requirements in the Investigator's opinion.
Exclusion criteria
Exclusion criteria: 1. Medical or psychiatric conditions that compromise the patient's ability to give informed consent. 2. Breast prosthesis in the target breast. 3. Concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy) delivered within the last 6 weeks prior to the start of the treatment. 4. Patient has other malignancies. 5. Pregnant or lactating. 6. History of severe allergy to ICG(Indocyanine Green) or albumin. 7. Significant renal or hepatic impairment.Inadequately controlled hypertension with or without current. antihypertensive medications. 8. History of myocardial infarction, transient ischemic attack, cerebro vascular accident, pulmonary embolism, uncontrolled congestive heart failure (CHF), significant liver disease, unstable angina within 6 months prior to enrollment. 9. Patients receiving anticoagulant therapy with vitamin K antagonists. 10. Patients receiving Class IA (e.g. Quinidine) or Class III (e.g. Dofetilide, Amiodarone, Sotalol) antiarrhythmic agents. 11. Evidence of QT prolongation on pre-treatment ECG (Males > 440 ms, Females >450 ms). 12. Magnesium, potassium and calcium levels below lower normal limit which is regarded clinically relevant with regards to study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tumor detection rate and reoperation rate of resection margin;The incidence of adverse reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| The consistency of fluorescence signal with postoperative pathology; ratio of fluorescence signal of tumor to surrounding tissue; | — |
Countries
China
Contacts
Public ContactGuojun Zhang
Xiang'an Hospital of Xiamen University
Outcome results
None listed