Clinical trial NCT02982148: Methylene Blue Intradermal Injection for Sentinel Lymph Node Biopsy for Breast Cancer Patients
Official title: Comparison Between Intradermal Injection and Subcutaneous Injection With Methylene Blue for Sentinel Lymph Node Biopsy for Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Breast Cancer Female
Early-Stage Breast Cancer
Sentinel Lymph Node
Keywords: sentinel lymph node biopsy
methylene blue
intradermal injection
subcutaneous injection
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 352
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: detective rate of sentinel lymph node
timeFrame: through study completion, an average of 1.5 year
Secondary outcomes:
measure: detective rate of blue lymphatic
timeFrame: through study completion, an average of 1.5 year
measure: incidence of adverse events
timeFrame: 1 month after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Fengxi Su, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/s0002-9610(02)00945-5.
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. doi: 10.1016/s0027-9684(15)31552-2.
citation: 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. Epub 2009 Nov 22.
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. doi: 10.1111/j.1075-122X.2006.00299.x.
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.
citation: Scheutz F. Drug addicts and local analgesia--effectivity and general side effects. Scand J Dent Res. 1982 Aug;90(4):299-305. doi: 10.1111/j.1600-0722.1982.tb00741.x.