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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||352 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
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
|Contact: Kai Chen, M.D.||86-15920164730|
|Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University||Recruiting|
|Guangzhou, Guangdong, China, 510120|
|Contact: Kai Chen, M.D. 86-15920164730 email@example.com|
|Sub-Investigator: Erwei Song, M.D., Ph.D.|
|Sub-Investigator: Kai Chen, M.D.|
|Principal Investigator:||Fengxi Su, M.D.||Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University|