Clinical trial NCT02479997: Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer Patients
Official title: Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer Patients Who Receive Neoadjuvant Therapy(Chemotherapy, Hormonal Therapy, Targeted Therapy); Clinical Study for 130 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Neoadjuvant chemotherapy
Indocyanine green (ICG)
Radioisotope (RI)
Near infrared fluorescence camera
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2015-06-24
Enrollment: 130
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Identification rate of sentinel lymphnode biopsy
timeFrame: Participants will be followed for 2 weeks from operation
Secondary outcomes:
measure: Duration of sentinel lymphnode biopsy
timeFrame: 3months follow up from the day of operation
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
Study officials:
affiliation: National Cancer Center
name: Seeyoun Lee
role: PRINCIPAL_INVESTIGATOR
References: