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

Primary Purpose

Breast Cancer Female, Early-Stage Breast Cancer, Sentinel Lymph Node

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
methylene blue intradermal injection
methylene blue subcutaneous injection
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Female focused on measuring sentinel lymph node biopsy, methylene blue, intradermal injection, subcutaneous injection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

methylene blue intradermal injection

methylene blue subcutaneous injection

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
incidence of adverse events
One month after surgery, researchers would record if any adverse events appeared by phone call follow-up.

Full Information

First Posted
November 29, 2016
Last Updated
December 2, 2016
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02982148
Brief Title
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

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female, Early-Stage Breast Cancer, Sentinel Lymph Node
Keywords
sentinel lymph node biopsy, methylene blue, intradermal injection, subcutaneous injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
352 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
methylene blue intradermal injection
Arm Type
Experimental
Arm Description
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.
Arm Title
methylene blue subcutaneous injection
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
methylene blue intradermal injection
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
methylene blue subcutaneous injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
detective rate of sentinel lymph node
Description
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.
Time Frame
through study completion, an average of 1.5 year
Secondary Outcome Measure Information:
Title
detective rate of blue lymphatic
Description
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.
Time Frame
through study completion, an average of 1.5 year
Title
incidence of adverse events
Description
One month after surgery, researchers would record if any adverse events appeared by phone call follow-up.
Time Frame
1 month after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kai Chen, M.D.
Phone
86-15920164730
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fengxi Su, M.D.
Organizational Affiliation
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai Chen, M.D.
Phone
86-15920164730
Email
chenkai23@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Erwei Song, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Kai Chen, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12383900
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.
Results Reference
background
PubMed Identifier
19110921
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.
Results Reference
background
PubMed Identifier
19931946
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.
Results Reference
background
PubMed Identifier
16958960
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.
Results Reference
background
PubMed Identifier
24415970
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.
Results Reference
background
PubMed Identifier
6957969
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.
Results Reference
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Methylene Blue Intradermal Injection for Sentinel Lymph Node Biopsy for Breast Cancer Patients

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