Breast Cancer Female, Early-Stage Breast Cancer, Sentinel Lymph Node
Conditions
Keywords
sentinel lymph node biopsy, methylene blue, intradermal injection, subcutaneous injection
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.
Interventions
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.
DEVICEmethylene blue subcutaneous injection
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.
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactKai Chen, M.D.
Outcome results
None listed