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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02982148
• Other study ID #: SLNB5010
• Status: Recruiting
• Phase: Phase 4
• First received: November 29, 2016
• Last updated: December 2, 2016
• Start date: May 2015
• Est. completion date: January 2017

Study information

• Verified date: November 2016
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Kai Chen, M.D.
• Phone: 86-15920164730
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Early-Stage Breast Cancer
• Sentinel Lymph Node

Intervention

Device:
• methylene blue intradermal injection
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.
• methylene 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.

Locations

Country	Name	City	State
China	Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (6)

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

Outcome

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