Comparison Study of Sentinel Lymph Node Biopsy by Multimodal Method in Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

Phase II Study of Comparison of Sentinel Lymph Node Biopsy Guided by The Multimodal Method of Indocyanine Green Fluorescence, Radioisotope and Blue Dye Versus the Radioisotope in Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01856452
• Other study ID #: NCC-1110212-2
• Status: Completed
• Phase: Phase 2
• First received: May 8, 2013
• Last updated: May 14, 2013
• Start date: September 2011
• Est. completion date: October 2012

Study information

• Verified date: May 2013
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: National Cancer Center
• Study type: Interventional

Clinical Trial Summary

Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cancer. It provides the surgeon the evidence of axillary lymph node metastasis, which determines the extent of surgery. Because effective SLNB can decrease the extent of axillary lymph node dissection, it is increasingly important. In general, radioactive colloid has been used for SLNB. In order to pursue more precise SLNB, the investigators developed a multimodal method enabling visual guidance with the mixture of indocyanine green, blue dye and radioisotope.

In this study, our hypotheses are as following:

1. Multimodal method enables to increase identification rate of SLNB

2. blue dye and indocyanine green provide the surgeon visual guidance to ensure better outcome

3. Multimodal method alleviates the shortcomings of indocyanine green and blue dye as an identification strategy

Description:

Indocyanine green Advantages: provides visualization of sentinel lymph node without incision

Blue dye Advantages: easy to employ; no toxicity Disadvantages: diffusion; absorption and disappearance of the marking within minutes

Radioisotope Advantages: can be used for lesions not accessible to Ultrasound; ideal for selective uptake to sentinel lymph node Disadvantages: not able to use palpation and visualization, confirms by gamma-probe only

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• clinically lymph node negative breast cancer patients

• consented patients with more than 20 years

Exclusion Criteria:

• history of breast cancer

• locally advanced breast cancer and metastatic breast cancer

• proven axillary lymph node metastasis

• history of axillary excisional or incisional biopsy, or dissection

• history of neoadjuvant chemotherapy

• pregnancy

• non-consented patients

• younger than 20 years old

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Device:
• the mixture including indocyanine green
Sentinel lymph node biopsy using near-infrared imaging system and gamma probe detector for the mixture of indocyanine green, blue dye, and radioisotope during operation
• radioisotope
Sentinel lymph node biopsy using gamma probe detector for radioisotope during operation

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
Primary	Time to sentinel lymph node biopsy	From the date of randomization, skin necrosis and dye staining are assessed up to 6 months after the operation (post op 3 mon and 6 mon follow-up).	up to 6 months	Yes
Secondary	Identification rate of sentinel lymph node biopsy	The number of participants with sentinel lymph node detection is assessed up to 13 months.	13 months	No