NCT02982148

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
352

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

December 5, 2016

Status Verified

November 1, 2016

Enrollment Period

1.7 years

First QC Date

November 29, 2016

Last Update Submit

December 2, 2016

Conditions

Breast Cancer FemaleEarly-Stage Breast CancerSentinel Lymph Node

Keywords

sentinel lymph node biopsymethylene blueintradermal injectionsubcutaneous injection

Outcome Measures

Primary Outcomes (1)

  • 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.

    through study completion, an average of 1.5 year

Secondary Outcomes (2)

  • detective rate of blue lymphatic

    through study completion, an average of 1.5 year

  • incidence of adverse events

    1 month after surgery

Study Arms (2)

methylene blue intradermal injection

EXPERIMENTAL

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 subcutaneous injection

ACTIVE COMPARATOR

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

Interventions

methylene blue intradermal injectionDEVICE

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.

methylene blue intradermal injection
methylene blue subcutaneous injectionDEVICE

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.

methylene blue subcutaneous injection

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (6)

  • 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.

    PMID: 12383900BACKGROUND

  • 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.

    PMID: 19110921BACKGROUND

  • 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.

    PMID: 19931946BACKGROUND

  • 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.

    PMID: 16958960BACKGROUND

  • 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.

    PMID: 24415970BACKGROUND

  • 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.

    PMID: 6957969BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Fengxi Su, M.D.

    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai Chen, M.D.

CONTACT

86-15920164730

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 29, 2016

First Posted

December 5, 2016

Study Start

May 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

December 5, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)