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NCT Number: NCT01856452

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

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

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

the mixture including indocyanine green

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

radioisotope

Device

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

Primary outcomes

  1. Time to sentinel lymph node biopsy

    Time frame: 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 outcomes

  1. Identification rate of sentinel lymph node biopsy

    Time frame: 13 months

    The number of participants with sentinel lymph node detection is assessed up to 13 months.

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 17, 2013
Registry last updated
May 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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