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

Peking University

Status: Unknown

Conditions: Breast Neoplasms

Treatments: Procedure: ICG+Methylene Blue

Study type: Observational

Funder types: Other

Identifiers

NCT02869815

PKUPHSLN003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

ICG+Methylene Blue

Description:

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.

Treatment:

Procedure: ICG+Methylene Blue