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

Sun Yat-sen University

Status: Unknown

Conditions: Sentinel Lymph Node Biopsy; Neoadjuvant Therapy; Breast Neoplasms

Treatments: Procedure: blue dye; Procedure: CEUS

Study type: Interventional

Funder types: Other

Identifiers

NCT04932460

2021332GD

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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350 participants in 1 patient group

CEUS+blue dye

Experimental group

Description:

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.

Treatment:

Procedure: blue dye

Procedure: CEUS