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

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ClinicalTrials.gov Identifier: NCT02982148
Recruitment Status : Unknown
Verified November 2016 by Fengxi Su, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Recruitment status was:  Recruiting
First Posted : December 5, 2016
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
Fengxi Su, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Female Early-Stage Breast Cancer Sentinel Lymph Node Device: methylene blue intradermal injection Device: methylene blue subcutaneous injection Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Intradermal Injection and Subcutaneous Injection With Methylene Blue for Sentinel Lymph Node Biopsy for Breast Cancer Patients
Study Start Date : May 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: methylene blue intradermal injection
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
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.
Active Comparator: methylene blue subcutaneous injection
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. detective rate of sentinel lymph node [ Time Frame: 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 Outcome Measures :
  1. detective rate of blue lymphatic [ Time Frame: 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.

  2. incidence of adverse events [ Time Frame: 1 month after surgery ]
    One month after surgery, researchers would record if any adverse events appeared by phone call follow-up.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02982148


Contacts
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Contact: Kai Chen, M.D. 86-15920164730

Locations
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China, Guangdong
Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Kai Chen, M.D.    86-15920164730    chenkai23@mail.sysu.edu.cn   
Sub-Investigator: Erwei Song, M.D., Ph.D.         
Sub-Investigator: Kai Chen, M.D.         
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators
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Principal Investigator: Fengxi Su, M.D. Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
More Information
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Publications:

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Responsible Party: Fengxi Su, professor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02982148    
Other Study ID Numbers: SLNB5010
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Fengxi Su, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University:
sentinel lymph node biopsy
methylene blue
intradermal injection
subcutaneous injection
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action