Clinical trial NCT02168452: Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer
Official title: Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer Patients Who Receive Neoadjuvant Chemotherapy; Observational Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
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: 2014-06-20
Enrollment: 5
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast cancer patients who receive neoadjuvant chemotherapy

Brief summary: This study aimed to evaluate the feasibility of dual sentinel node staining method using mixture of indocyanine green(ICG) and radioisotope (RI) in breast cancer patients who receive neoadjuvant chemotherapy.

Over the past few years, several studies have found using methylene blue, isosulfan blue, indocyanine green or radioisotope alone by detection method had several disadvantages.

In this study we 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.

Detailed description: * 5 patients who receive neoadjuvant chemotherapy with cN1-cN2 or cT2 on TNM staging
* sentinel lymph node biopsy(SLNB) by sentinel lymph node staining method using mixture of indocyanine green (ICG) with radioisotope (RI).
* indocyanine green (ICG) penetrates human tissue to depths of several millimeters to 2cm, and the fluorescence can be detected percutaneously in real time.
* using RI only has several disadvantages such as invisibility,interference. RI only detect sound or confirm numerical value through gamma probe.
* ICG can be visualized with a fluorescence imaging system
* confirm Identification rate of sentinal lymph node biopsy, and duration of sentinel lymph node biopsy

Eligibility criteria: Inclusion Criteria:

* breast cancer patients who receive neoadjuvant chemotherapy
* cN1-cN2 or cT2 on tumor lymphnode metastasis classification(TNM)
* 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)
* history of hormone therapy or targeted therapy
* stage 4 breast cancer
* pregnancy

Primary outcomes:
measure: Identification rate of sentinal lymph node biopsy
timeFrame: during operation
Secondary outcomes:
measure: duration of sentinel lymph node biopsy
timeFrame: during operation
Other outcomes:
measure: Physical assess
timeFrame: follwing up a week to 3month
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
Study officials:
affiliation: National Cancer Center, Korea
name: Seeyoun Lee
role: PRINCIPAL_INVESTIGATOR
References: