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

Phase 2

Recruiting

• Conditions: Sentinel Lymph Node Biopsy in Breast Cancer Patients; Cancer - Breast; Surgery - Surgical techniques

• Registration Number: ACTRN12612000109808
• Lead Sponsor: Peking University People's Hospital Breast Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1.Histologically diagnosed as invasive breast cancer (T1-T3)
2.Clinical negative axillary lymph node
3.No distant metastasis

Exclusion Criteria

1.Histologically identified positive lymph node
2.Palpable positive lymph node
3.A positive history of anaphylaxis or iodine allergy
4.A history of axillary surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.The number of indentified lymph node,including the fluorescent and blue stained nodes in the combination group,but only the blue nodes in the methylene blue alone group.[after the surgery];2.Successful detection rate of sentinel lymph node,which would be calculated through clinical records.[completion of enrollment];3.The complication rate,including anaphylaxis ,skin events and other complication comfirmed by the investigator ralated to the tracer use.[3 months,6 months,1 year.]

Secondary Outcome Measures

Name	Time	Method
The local recurrence in the ipsilateral axilla,and overall survival would be assessed through hospital follow-up which would be confirmed with telephone call in special cases.[3 years,5 years]