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

Overview

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.

Full Title of Study: “Comparison Between Intradermal Injection and Subcutaneous Injection With Methylene Blue for Sentinel Lymph Node Biopsy for Breast Cancer Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2017

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Fengxi Su, professor – Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • Overall Official(s)
    • Fengxi Su, M.D., Principal Investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • Overall Contact(s)
    • Kai Chen, M.D., 86-15920164730

References

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.

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