ICG and Blue Dye Guided Sentinel Lymph Node Biopsy in Patients Underwent Neoadjuvant Therapy

• Conditions: Breast Neoplasms
• Interventions: Procedure: ICG+Methylene Blue

• Registration Number: NCT02869815
• Lead Sponsor: Peking University People's Hospital

Brief Summary

The value of sentinel lymph node biopsy (SLNB) in patients underwent neoadjuvant chemotherapy is controversial. Lower detection rate and higher false negative rate are the main problem. The purpose of this study is to determine the detection rate and the false negative rate of SLNB by indocyanine green (ICG) in addition to blue dye (methylene blue) after neoadjuvant chemotherapy in patients with large or locally advanced breast cancer. This is a single arm clinical trial.

Detailed Description

Patients indicated for neoadjuvant therapy would be recruited in this study. During the surgery, SLNB using the dual tracing method would be applied before axillary clearance. After the surgery, histological results of the SLN and non-SLN would be analysed.

Study Timeline

• Study First Submitted: 2016-07-29
• Study Start: 2016-08
• Study First Submitted QC: 2016-08-11
• Study First Posted: 2016-08-17
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-26
• Last Update Posted: 2019-05-29
• Primary Completion: 2019-08
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• Patients indicated for neoadjuvant therapy
• Have complete evaluation of the axillary status
• Planned for axillary clearance after neoadjuvant therapy

Exclusion Criteria

• Sensitive to Iodine
• Inflammatory disease
• Patient's refusal to join the trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICG+Methylene Blue	ICG+Methylene Blue	ICG+Methylene Blue: Sentinel Lymph Node (SLN) identification and resection using dual tracer technique with the sub-areolar injection of ICG+Blue dye, before surgery.

Primary Outcome Measures

Name	Time	Method
Detection rate of SLN	Immediate	The number of successful SLNB / total number of SLNB

Secondary Outcome Measures

Name	Time	Method
False negative rate of SLNB	1 week after the surgery	The number of patients with positive SLN / the number of patients with positive node
Adverse effect	Half a year after the surgery	Prophylaxis reaction, skin complication

Trial Locations

Locations (1)

Breast Center, Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China