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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02168452
• Other study ID #: NCC-1410201-1
• Status: Completed
• Phase: N/A
• First received: June 18, 2014
• Last updated: February 4, 2016
• Start date: June 2014
• Est. completion date: January 2015

Study information

• Verified date: February 2016
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: National Cancer Center
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: January 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• sentinel 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

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical assess	assess pigmented skin lesion; assess for other complication	follwing up a week to 3month	Yes
Primary	Identification rate of sentinal lymph node biopsy	It was defined as the ability to identify a sentinel lymph node successfully.	during operation	Yes
Secondary	duration of sentinel lymph node biopsy	It was defined as the time from the skin incision to complet removal of the first sentinel lymph node.	during operation	Yes