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

Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer Patients Who Receive Neoadjuvant Chemotherapy; Observational Pilot Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02168452

Enrollment

Registered

2014-06-20

Start date

2014-06-30

Completion date

2015-01-31

Last updated

2016-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Neoadjuvant chemotherapy, Indocyanine green (ICG), Radioisotope (RI), Near infrared fluorescence camera

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

Interventions

PROCEDUREsentinel lymph node biopsy(SLNB)

* incision will be made over the skin site that had fluorescence lymphatic flow which visualized using fluorescence imaging camera and gamma probe. * double check after removal of the sentinel lymph node * sending frozen biopsy

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Identification rate of sentinal lymph node biopsy	during operation	It was defined as the ability to identify a sentinel lymph node successfully.

Secondary

Measure	Time frame	Description
duration of sentinel lymph node biopsy	during operation	It was defined as the time from the skin incision to complet removal of the first sentinel lymph node.

Other

Measure	Time frame	Description
Physical assess	follwing up a week to 3month	* assess pigmented skin lesion * assess for other complication

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026