Comparison Study of Sentinel Lymph Node Biopsy by Multimodal Method in Breast Cancer

National Cancer Center (NCC)

Status and phase: Completed; Phase 2

Conditions: Breast Neoplasms

Treatments: Device: radioisotope; Device: the mixture including indocyanine green

Study type: Interventional

Funder types: Other

Identifiers

NCT01856452

NCC-1110212-2

Details and patient eligibility

About

Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cancer. It provides the surgeon the evidence of axillary lymph node metastasis, which determines the extent of surgery. Because effective SLNB can decrease the extent of axillary lymph node dissection, it is increasingly important. In general, radioactive colloid has been used for SLNB. In order to pursue more precise SLNB, the investigators developed a multimodal method enabling visual guidance with the mixture of indocyanine green, blue dye and radioisotope.

In this study, our hypotheses are as following:

1. Multimodal method enables to increase identification rate of SLNB
2. blue dye and indocyanine green provide the surgeon visual guidance to ensure better outcome
3. Multimodal method alleviates the shortcomings of indocyanine green and blue dye as an identification strategy

Full description

Indocyanine green Advantages: provides visualization of sentinel lymph node without incision

Blue dye Advantages: easy to employ; no toxicity Disadvantages: diffusion; absorption and disappearance of the marking within minutes

Radioisotope Advantages: can be used for lesions not accessible to Ultrasound; ideal for selective uptake to sentinel lymph node Disadvantages: not able to use palpation and visualization, confirms by gamma-probe only

Enrollment: 86 patients

Sex: Female

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• clinically lymph node negative breast cancer patients
• consented patients with more than 20 years

Exclusion criteria

• history of breast cancer
• locally advanced breast cancer and metastatic breast cancer
• proven axillary lymph node metastasis
• history of axillary excisional or incisional biopsy, or dissection
• history of neoadjuvant chemotherapy
• pregnancy
• non-consented patients
• younger than 20 years old

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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86 participants in 2 patient groups

radioisotope

Active Comparator group

Description:

sentinel lymph node operation using radioisotope in the breast cancer patients

Treatment:

Device: radioisotope

the mixture including indocyanine green

Experimental group

Description:

sentinel lymph node operation using the mixture of indocyanine green, blue dye and radioisotope in the breast cancer patients

Treatment:

Device: the mixture including indocyanine green