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

Phase 2

Completed

• Conditions: Breast Neoplasms
• Interventions: Device: radioisotope; Device: the mixture including indocyanine green

• Registration Number: NCT01856452
• Lead Sponsor: National Cancer Center, Korea

Brief 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

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-05
• Study First Submitted: 2013-05-08
• Study First Submitted QC: 2013-05-14
• Last Update Submitted: 2013-05-14
• Study First Posted: 2013-05-17
• Last Update Posted: 2013-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 86

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
radioisotope	radioisotope	sentinel lymph node operation using radioisotope in the breast cancer patients
the mixture including indocyanine green	the mixture including indocyanine green	sentinel lymph node operation using the mixture of indocyanine green, blue dye and radioisotope in the breast cancer patients

Primary Outcome Measures

Name	Time	Method
Time to sentinel lymph node biopsy	up to 6 months	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).

Secondary Outcome Measures

Name	Time	Method
Identification rate of sentinel lymph node biopsy	13 months	The number of participants with sentinel lymph node detection is assessed up to 13 months.

Trial Locations

Locations (1)

National Cancer Center; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of