Contrast-enhanced Ultrasonography Combined With Blue Dye as Dual-tracer for Sentinel Lymph Node Biopsy

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Breast Neoplasms, Neoadjuvant Therapy, Sentinel Lymph Node Biopsy

Intervention / Treatment
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* Procedure: CEUS
* Procedure: blue dye


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CEUS+blue dye<br>The included patients will accept essential tests and CEUS before and after neoadjuvant chemotherapy to evaluate axillary lymph nodes status. When patients finish neoadjuvant therapy, SLNB with or without axillary lymph node dissection will be performed using CEUS lymphatic mapping to mark SLN on the skin combined with blue dye. | Procedure: CEUS<br>* CEUS is performed before neoadjuvant treatment and surgery to evaluate the status of axillary lymph node and locate the sentinel lymph node.<br>Procedure: blue dye<br>* Before operation, blue dye is injected for sentinel lymph node mapping.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| False negative rate | 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%. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The detective rate of sentinel lymph node biopsy | 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%. | 6 months | 
| The average numbers of sentinel lymph node | 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%. | 6 months | 
| The accuracy of CEUS in evaluation of axillary lymph nodes in breast cancer | 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%. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contrast enhanced ultrasonography