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

Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy Using the Navigation of the Combination of Indocyanine and Blue Dye in Patients With Breast Cancer

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02869815

Enrollment

150

Registered

2016-08-17

Start date

2016-08-31

Completion date

2020-08-31

Last updated

2019-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

Methylene blue, Indocyanine green, Neoadjuvant Therapy, Sentinel Lymph Node Biopsy, Breast Neoplasms

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.

Interventions

PROCEDUREICG+Methylene Blue

ICG+Methylene Blue Arm: One ml of methylene blue (1%) would be in injected sub-areolarly 5 minutes before surgery, and 1ml of ICG (0.125%) in the same site 3 minutes later. Massage of the breast would be applied to facilitate the movement of the tracers. A small incision would be made in the axilla, and a special device would be used to search the light nodes. During the sampling, blue nodes would also be resected . After the completion of SLNB, complete axillary dissection would be carried out.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Detection rate of SLN	Immediate	The number of successful SLNB / total number of SLNB

Secondary

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactHoupu Yang, M.D.

yanghoupu@pkuph.edu.cn+86-10-88324010

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026