- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02982148
Methylene Blue Intradermal Injection for Sentinel Lymph Node Biopsy for Breast Cancer Patients
December 2, 2016 updated by: Fengxi Su, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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.
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
352
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kai Chen, M.D.
- Phone Number: 86-15920164730
Study Locations
-
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Guangdong
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Guangzhou, Guangdong, China, 510120
- Recruiting
- Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University
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Sub-Investigator:
- Erwei Song, M.D., Ph.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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through study completion, an average of 1.5 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
through study completion, an average of 1.5 year
|
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.
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1 month after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Fengxi Su, M.D., Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Anticipated)
January 1, 2017
Study Completion (Anticipated)
January 1, 2017
Study Registration Dates
First Submitted
November 29, 2016
First Submitted That Met QC Criteria
December 2, 2016
First Posted (Estimate)
December 5, 2016
Study Record Updates
Last Update Posted (Estimate)
December 5, 2016
Last Update Submitted That Met QC Criteria
December 2, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SLNB5010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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