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

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University352 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

352

Conditions

Breast Cancer Female Early-Stage Breast Cancer Sentinel Lymph Node

Interventions

methylene blue intradermal injectionDEVICE

Methylene blue has been prove to be effective and safe as a blue dye for sentinel lymph node biopsy in early breast cancer patient. But it was also reported by some article that adverse skin lesions appeared after methylene blue injections for sentinel lymph node localization. But the effectiveness and safety of methylene blue intradermal injection has not yet been investigated.

methylene blue subcutaneous injectionDEVICE

Methylene blue subcutaneous injection has become one of the standard method for sentinel lymph node biopsy for breast cancer patients. In such case, we use this method to be an active comparator for the intradermal injection group.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

detective rate of sentinel lymph node

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.

Time frame: through study completion, an average of 1.5 year

Secondary Outcomes

detective rate of blue lymphatic

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.

Time frame: through study completion, an average of 1.5 year

incidence of adverse events

One month after surgery, researchers would record if any adverse events appeared by phone call follow-up.

Time frame: 1 month after surgery

Central Contacts

Kai Chen, M.D.

CONTACT

86-15920164730

Data from ClinicalTrials.gov

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