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Spots Global Cancer Trial Database for Comparison Study of Sentinel Lymph Node Biopsy by Multimodal Method in Breast Cancer

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Trial Identification

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

Official 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

Study ID: NCT01856452

Study Description

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

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

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

Contact Details

Name: So-Youn Jung

Affiliation: National Cancer Center, Korea

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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