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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01856452

Enrollment

Registered

2013-05-17

Start date

2011-09-30

Completion date

2012-10-31

Last updated

2013-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

Sentinel lymph node, multimodal, breast cancer

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

Interventions

DEVICEthe 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

DEVICEradioisotope

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026