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

NCT ID: NCT01856452

Last Updated: 2013-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-10-31

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

Conditions

Breast Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

radioisotope

sentinel lymph node operation using radioisotope in the breast cancer patients

Group Type: ACTIVE_COMPARATOR

radioisotope

Intervention Type: DEVICE

Sentinel lymph node biopsy using gamma probe detector for radioisotope during operation

the mixture including indocyanine green

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

Group Type: EXPERIMENTAL

the mixture including indocyanine green

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

radioisotope

Sentinel lymph node biopsy using gamma probe detector for radioisotope during operation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: lead

Responsible Party

So-Youn Jung

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

So-Youn Jung

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center, Korea

Locations

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

NCC-1110212-2

Identifier Type: -

Identifier Source: org_study_id