NCT01856452

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Accepted

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

Detailed 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

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
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
DEVICE	radioisotope	Sentinel lymph node biopsy using gamma probe detector for radioisotope during operation

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2013-05-17
• Last updated: 2013-05-17

Locations

1 site across 1 country: South Korea