Breast Neoplasms, Neoadjuvant Therapy, Sentinel Lymph Node Biopsy
Conditions
Keywords
contrast enhanced ultrasonography
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.
Interventions
PROCEDURECEUS
CEUS is performed before neoadjuvant treatment and surgery to evaluate the status of axillary lymph node and locate the sentinel lymph node.
PROCEDUREblue dye
Before operation, blue dye is injected for sentinel lymph node mapping.
Sponsors
The Seventh Affiliated Hospital of Sun Yat-sen University
Affiliated Hospital of Guangdong Medical University
First Affiliated Hospital of Shantou University Medical College
First Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| False negative rate | 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
| Measure | Time frame | Description |
|---|---|---|
| The detective rate of sentinel lymph node biopsy | 6 months | The detective rate of SLNB after neoadjuvant therapy when using blue dye and CEUS lymphatic mapping as dual tracer. The detective rate is calculated as the number of patients in whom SLN can be detected during SLNB divided by the number of patients with the treatment of SLNB and then multiplied by 100%. |
| The average numbers of sentinel lymph node | 6 months | The average numbers of sentinel lymph node is calculated as the number of all SLNs detected during SLNB divided by the number of patients received SLNB and then multiplied by 100%. |
| The accuracy of CEUS in evaluation of axillary lymph nodes in breast cancer | 6 months | The accuracy of CEUS in evaluation of axillary lymph nodes in breast cancer patients before and after neoadjuvant therapy. The accuracy rate is calculated as the number of true positive plus true negative cases divided by the number of patients then multiplied by 100%. |
Countries
China
Contacts
Primary ContactYing Lin
Backup ContactZhen Shan
Outcome results
None listed