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

Overview

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

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: October 2012

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

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

Arms, Groups and Cohorts

  • Active Comparator: radioisotope
    • sentinel lymph node operation using radioisotope in the breast cancer patients
  • Experimental: the mixture including indocyanine green
    • sentinel lymph node operation using the mixture of indocyanine green, blue dye and radioisotope in the breast cancer patients

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • National Cancer Center, Korea
  • Provider of Information About this Clinical Study
    • Principal Investigator: So-Youn Jung, Medical Doctor – National Cancer Center, Korea
  • Overall Official(s)
    • So-Youn Jung, Principal Investigator, National Cancer Center, Korea

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.