Methylene Blue Intradermal Injection for Sentinel Lymph Node Biopsy for Breast Cancer Patients

Phase 4

• Conditions: Breast Cancer Female; Sentinel Lymph Node; Early-Stage Breast Cancer

• Registration Number: NCT02982148
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

This study is designed to compare the effectiveness of intradermal injection and subcutaneous injection with methylene blue for early-stage breast cancer patients who need sentinel lymph node biopsy.

Detailed Description

After fully informing and consent, patients recruited would be randomized 1:1 to intradermal injection group and subcutaneous injection group. Investigators aimed to find out the difference in sentinel lymph nodes detected rate, blue lymphatic detected rate and complication incidence between the two groups.

Study Timeline

• Study Start: 2015-05
• Status Verified: 2016-11
• Study First Submitted: 2016-11-29
• Study First Submitted QC: 2016-12-02
• Last Update Submitted: 2016-12-02
• Study First Posted: 2016-12-05
• Last Update Posted: 2016-12-05
• Primary Completion: 2017-01
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 352

Inclusion Criteria

• who sign the informed consent form
• pathological diagnosed, without distant metastasis, early stage invasive breast cancer patients
• did not undergo neoadjuvant chemotherapy, endocrinotherapy or targeted therapy previously
• without breast and axillary surgery history
• Ejection fraction score in normal range accord to cardiac doppler
• Eastern Cooperative Oncology Group score ≤0-2
• axillary lymph node clinical negative

Exclusion Criteria

• pregnancy
• any history of malignant tumor within five years
• diagnosis of multi-center, multi-focal or bilateral breast cancer
• history of breast tumor incision biopsy or vacuum-assisted biopsy
• methylene blue allergic
• appear with severe systematic disease or disfunction of any organ

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
detective rate of sentinel lymph node	through study completion, an average of 1.5 year	Right after each of the sentinel lymph node biopsy, the investigators would collect data of whether it was successful or not and the amount of sentinel lymph nodes that shown out by the certain intervention.

Secondary Outcome Measures

Name	Time	Method
detective rate of blue lymphatic	through study completion, an average of 1.5 year	The researcher would record if the surgeons could see blue lymphatic during the procedure of locating sentinel lymph node in use of the certain intervention.
incidence of adverse events	1 month after surgery	One month after surgery, researchers would record if any adverse events appeared by phone call follow-up.

Trial Locations

Locations (1)

Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China