RecruitingPhase 2Phase 3ACTRN12612000109808

A Randomized Trial Compared the Efficacy and Safety of Combined Use of Indocyanine Green Fluorescence and Methylene Blue Dye Versus Methylene Blue Dye alone for Sentinel Lymph Node Biopsy in Breast Cancer Patients


Sponsor

Peking University People's Hospital Breast Cancer Center

Enrollment

100 participants

Start Date

Jan 5, 2011

Study Type

Interventional

Conditions

Summary

Methylene blue is widely used in developing country for SLNB.The ICG is an innovative fluorescent tracer that could be visualized by near-infrared camera.This trial is designed to compare the efficacy and Safety of Combined Use of ICG Fluorescence and Methylene Blue Dye versus dye alone for SLNB in Breast Cancer Patients.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 85 Yearss

Plain Language Summary

Simplified for easier understanding

This trial compares two techniques for finding the sentinel lymph node (the first lymph node that breast cancer cells travel to) in women with early breast cancer. One technique uses blue dye alone; the other combines blue dye with a special fluorescent tracer called indocyanine green (ICG) that glows under infrared light. Finding the right lymph node is important to avoid removing too many, which can cause complications. The study measures how accurately each approach identifies the sentinel node. You may be eligible if: - You are female, aged 18 to 85 - You have been diagnosed with invasive breast cancer (tumour stage T1 to T3) - Your lymph nodes in the armpit are clinically normal (not enlarged) - Your cancer has not spread to distant parts of the body You may NOT be eligible if: - Your lymph nodes have already been confirmed as cancer-positive - You have a palpable (felt-by-hand) enlarged lymph node in the armpit - You have a history of severe allergy or iodine allergy - You have had previous surgery in the armpit area Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The patients are randomly assigned to one of two groups, receiving combined use of ICG and methylene blue(Combination Group) or methylene blue alone as the lymphatic mapping tracer.Methylene blue will

The patients are randomly assigned to one of two groups, receiving combined use of ICG and methylene blue(Combination Group) or methylene blue alone as the lymphatic mapping tracer.Methylene blue will be injected periareolarly or peritumorally 8 minutes before the standard biopsy insicion.In the combination group,ICG would be injected 3 minutes before the surgery.In the combination group, sentinel lymph nodes are identified by ICG fluorescence using a near-infrared camera and blue stained lymph nodes found during this precedure will also be resected, while in blue dye alone group, sentinel lymph nodes are identified as blue nodes along the blue lymphatic vessel.


Locations(1)

Beijing, China

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ACTRN12612000109808