Validation study on the clinical usefulness of the ICG fluoresence method for detecting sentinel lymph node in early breast cancer in comparion with the RI method
Not Applicable
- Conditions
- early breast cancer
- Registration Number
- JPRN-UMIN000005167
- Lead Sponsor
- Kyoto University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 840
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients who had surgical biopsy or operation on the axilla. 2)Patient who had history of alleragy against ICG reagent or iodine. 3)Pregnant or breast feeding. 4)Patients who are judged inappropriate for the clinical trial by doctors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method sensitivity
- Secondary Outcome Measures
Name Time Method 1) identification rate of SLN 2)additive effect of ICG fluoresence method on RI method. 3) identificaiton rate of SLN before and after primary systemic therapy. 4) involvement in SLN and non SLN. 5) adverse event of ICG fluoresence method.