A Prospective Multi-center Study: Contrast-enhanced Ultrasonography Combined With Blue Dye as Dual-tracer for Sentinel Lymph Node Biopsy After Neoadjuvant Therapy in Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- False negative rate
Study Overview
Brief Summary
False negative rate (FNR) in patients who has accepted neoadjuvant therapy is high. Blue dye and radioisotope as dual-tracer can decrease FNR. Several large clinical trials showed that using dual trace with blue dye and radioisotope can reduce the FNR to less than 10%. But radioisotope is still not approved in China and can cause radiocontamination. A novel dual-tracer which can decrease the FNR in patients after neoadjuvant therapy is urged to be explored. Contrast enhanced ultrasonography (CEUS) can make the lymphatic drainage path and sentinel lymph nodes visible. Retrospective studies found that CEUS can locate SLN precisely. So this clinical trial aim to evaluate FNR, detective rate and numbers of SLN by using CEUS combined with blue dye as dual-tracer in sentinel lymph node biopsy in breast cancer patients after neoadjuvant therapy and the accuracy of CEUS for the diagnosis of lymph node metastasis before and after neoadjuvant therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥18 years old female；
- •ECOG：0 - 1；
- •Biopsy confirmed invasive breast cancer；
- •cT1-4N0-3；
- •Signed informed consent.
Exclusion Criteria
- •Inflammatory breast cancer；
- •Received ipsilateral axillary surgery previously；
- •During pregnancy.
Outcomes
Primary Outcomes
False negative rate
Time Frame: 6 months
The false negative rate (FNR) of sentinel lymph node biopsy using dual-tracer with CEUS and blue dye after neoadjuvant chemotherapy in invasive breast cancer patients. The FNR is calculated as the number of false negative cases divided by the number of false negative plus true positive cases and then multiplied by 100%.
Secondary Outcomes
- The detective rate of sentinel lymph node biopsy(6 months)
- The average numbers of sentinel lymph node(6 months)
- The accuracy of CEUS in evaluation of axillary lymph nodes in breast cancer(6 months)
Investigators
Ying Lin
Vice Director of Department of Breast Surgery
First Affiliated Hospital, Sun Yat-Sen University