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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison Between Intradermal Injection and Subcutaneous Injection With Methylene Blue for Sentinel Lymph Node Biopsy for Breast Cancer Patients

Conditions
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Breast Cancer Female, Early-Stage Breast Cancer, Sentinel Lymph Node

Intervention / Treatment
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* Device: methylene blue intradermal injection
* Device: methylene blue subcutaneous injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: methylene blue intradermal injection<br>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. | Device: methylene blue intradermal injection<br>* 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.<br>|
| Active Comparator: methylene blue subcutaneous injection<br>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. | Device: methylene blue subcutaneous injection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | through study completion, an average of 1.5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 1 month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sentinel lymph node biopsy, methylene blue, intradermal injection, subcutaneous injection