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

Sun Yat-sen University

Status and phase: Unknown; Phase 4

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

Treatments: Device: methylene blue intradermal injection; Device: methylene blue subcutaneous injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02982148

SLNB5010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 352 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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352 participants in 2 patient groups

methylene blue intradermal injection

Experimental group

Description:

For patients randomized to intradermal injection before surgery began, 0.5ml 0.4% methylene blue(1ml methylene blue mixed up with 1.5ml saline) would be injected sub-areola (12 o'clock , 3 o'clock , 6 o'clock , 9 o'clock) intradermally, 0.1ml respectively, or peritumoral depending on the tumor location, 10-15 minutes before skin incision. The breast was massaged for 5 minutes to facilitate the identification of blue lymphatic vessels and the lymph nodes.

Treatment:

Device: methylene blue intradermal injection

methylene blue subcutaneous injection

Active Comparator group

Description:

For patients randomized to subcutaneous injection before surgery began, 0.5ml 100% methylene blue would be injected sub-areola subcutaneously(12 o'clock , 3 o'clock , 6 o'clock , 9 o'clock), 0.1ml respectively or peritumoral depending on the tumor location, 10-15 minutes before skin incision. The breast was massaged for 5 minutes to facilitate the identification of blue lymphatic vessels and the lymph nodes.

Treatment:

Device: methylene blue subcutaneous injection