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

May 14, 2013 updated by: So-Youn Jung, National Cancer Center, Korea

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
        • National Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: radioisotope
sentinel lymph node operation using radioisotope in the breast cancer patients
Device: radioisotope
Sentinel lymph node biopsy using gamma probe detector for radioisotope during operation
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

May 8, 2013

First Submitted That Met QC Criteria

May 14, 2013

First Posted (Estimate)

May 17, 2013

Study Record Updates

Last Update Posted (Estimate)

May 17, 2013

Last Update Submitted That Met QC Criteria

May 14, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC-1110212-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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