Breast Cancer Female Clinical Trial
Official title:
Comparison Between Intradermal Injection and Subcutaneous Injection With Methylene Blue for Sentinel Lymph Node Biopsy for Breast Cancer Patients
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.
Status | Recruiting |
Enrollment | 352 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
China,
Abdollahi A, Jangjoo A, Dabbagh Kakhki VR, Rasoul Zakavi S, Memar B, Naser Forghani M, Mehrabibahar M, Sadeghi R. Factors affecting sentinel lymph node detection failure in breast cancer patients using intradermal injection of the tracer. Rev Esp Med Nucl. 2010 Mar-Apr;29(2):73-7. doi: 10.1016/j.remn.2009.10.001. — View Citation
Golshan M, Nakhlis F. Can methylene blue only be used in sentinel lymph node biopsy for breast cancer? Breast J. 2006 Sep-Oct;12(5):428-30. — View Citation
Gumus M, Gumus H, Jones SE, Jones PA, Sever AR, Weeks J. How long will I be blue? Prolonged skin staining following sentinel lymph node biopsy using intradermal patent blue dye. Breast Care (Basel). 2013 Jun;8(3):199-202. doi: 10.1159/000352092. — View Citation
Scheutz F. Drug addicts and local analgesia--effectivity and general side effects. Scand J Dent Res. 1982 Aug;90(4):299-305. — View Citation
Stradling B, Aranha G, Gabram S. Adverse skin lesions after methylene blue injections for sentinel lymph node localization. Am J Surg. 2002 Oct;184(4):350-2. — View Citation
Teknos D, Ramcharan A, Oluwole SF. Pulmonary edema associated with methylene blue dye administration during sentinel lymph node biopsy. J Natl Med Assoc. 2008 Dec;100(12):1483-4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | Yes |
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