Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer Patients

National Cancer Center (NCC)

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Indocyanine green; Drug: Radioisotope

Study type: Interventional

Funder types: Other

Identifiers

NCT02479997

NCC-1410201-2

Details and patient eligibility

About

This study aimed to compare detection rate between dual sentinel node staining method using mixture of indocyanine green (ICG) with radioisotope(RI), and RI only.

To identify the first lymph node(s) along the lymphatic drainage pathway from the primary tumor in the breast cancer using RI only has several disadvantages such as invisibility, interference. As ICG can be visualized with a fluorescence imaging system, we expects dual sentinel lymph node staining method had better outcomes.

Full description

Using mixture of indocyanine green (ICG) with radioisotope (RI) can guide surgeons to identify the first lymph node(s) along the lymphatic drainage pathway from the primary tumor in the breast to the axillary lymph node basin.

Last pilot study, sentinel lymph node was successfully identified by using dual method of ICG and RI in 5 patients. In this study, when radiolabeled colloid is used, a gamma probe identifies radioactivity in the lymph nodes in the axilla. If ICG, RI both used, Near infrared fluorescence camera visualized during surgery.

As investigators measure node detection time from axillary approach moment, investigators are going to compare detection rate. (ICG+RI or RI only). And determine the accuracy.

Sentinel lymph node mapping with both ICG and radiolabeled colloid mapping agents was recommended to maximize the likelihood of SLN identification and to minimize the possibility of missing SLNs, which could result in a false-negative event.The protocol required that 130 patients who receive neoadjuvant chemotherapy.

In this study investigators expects using mixture of indocyanine green (ICG) with radioisotope (RI) has potential to improve sentinel lymph node (SLN) mapping in breast cancer patients who receive neoadjuvant chemotherapy.

Sentinel lymph node mapping with both ICG and radiolabeled colloid mapping agents was recommended to maximize the likelihood of SLN identification and to minimize the possibility of missing SLNs, which could result in a false-negative event.

Enrollment: 130 patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• breast cancer patients who receive neoadjuvant therapy (chemotherapy,hormonal therapy, targeted therapy)
• cN1-cN2 or cN3( but must be complete response status)on tumor lymphnode metastasis classification( TNM) after neoadjuvant therapy.
• ECOG Performance status 0 or 1
• consented patients with more than 20 years, less than 70 years

Exclusion criteria

• history of breast cancer
• early stage breast cancer
• history of excisional or incisional biopsy or axillary dissection
• inflammatory breast carcinoma
• cN3 on tumor lymphnode metastasis classification(TNM)
• stage 4 breast cancer
• pregnancy

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

Radioisotope (RI)

Active Comparator group

Description:

Using RI only as SLNB mapping in breast cancer patients who receive neoadjuvant chemotherapy. Interventions - patient assigend RI groups are injected only RI * fill the Primay Case Report Form during surgery * PCRF including SLN detection time, duration of SLN approch time to 1st sentinel node dection time, incision length , depth, RI +/- .

Treatment:

Drug: Radioisotope

Drug: Indocyanine green

Indocyanine green (ICG) +RI

Active Comparator group

Description:

Dual sentinel node staining method using mixture of indocyanine green (ICG) and radioisotope (RI) in breast cancer patients who receive neoadjuvant chemotherapy. Interventions - patient assigend RI groups are injected RI +ICG * prepare fluorescence camera when the surgery begin * surgeon uses the camera to decect fluorescence flow on SLN * fill the Primay Case Report Form during surgery * PCRF including SLN detection time, duration of SLN approch time to 1st sentinel node dection time, incision length , depth, RI +/- , ICG+/-

Treatment:

Drug: Radioisotope

Drug: Indocyanine green