Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000109808
Ethics application status
Yes
Date submitted
19/01/2012
Date registered
23/01/2012
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomized Trial Compared the Efficacy and Safety of Combined Use of Indocyanine Green Fluorescence and Methylene Blue Dye Versus Methylene Blue Dye alone for Sentinel Lymph Node Biopsy in Breast Cancer Patients
Scientific title
A Randomized Trial Compared the Efficacy and Safety of Combined Use of Indocyanine Green Fluorescence and Methylene Blue Dye Versus Methylene Blue Dye alone for Sentinel Lymph Node Biopsy in Breast Cancer Patients
Secondary ID [1] 279733 0
Nil
Universal Trial Number (UTN)
U1111-1126-9167
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sentinel Lymph Node Biopsy in Breast Cancer Patients 285578 0
Condition category
Condition code
Cancer 285772 285772 0 0
Breast
Surgery 285773 285773 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients are randomly assigned to one of two groups, receiving combined use of ICG and methylene blue(Combination Group) or methylene blue alone as the lymphatic mapping tracer.Methylene blue will be injected periareolarly or peritumorally 8 minutes before the standard biopsy insicion.In the combination group,ICG would be injected 3 minutes before the surgery.In the combination group, sentinel lymph nodes are identified by ICG fluorescence using a near-infrared camera and blue stained lymph nodes found during this precedure will also be resected, while in blue dye alone group, sentinel lymph nodes are identified as blue nodes along the blue lymphatic vessel.
Intervention code [1] 284031 0
Treatment: surgery
Comparator / control treatment
Methylene Blue Alone Group
Control group
Active

Outcomes
Primary outcome [1] 286297 0
1.The number of indentified lymph node,including the fluorescent and blue stained nodes in the combination group,but only the blue nodes in the methylene blue alone group.
Timepoint [1] 286297 0
after the surgery
Primary outcome [2] 286298 0
2.Successful detection rate of sentinel lymph node,which would be calculated through clinical records.
Timepoint [2] 286298 0
completion of enrollment
Primary outcome [3] 286299 0
3.The complication rate,including anaphylaxis ,skin events and other complication comfirmed by the investigator ralated to the tracer use.
Timepoint [3] 286299 0
3 months,6 months,1 year.
Secondary outcome [1] 295561 0
The local recurrence in the ipsilateral axilla,and overall survival would be assessed through hospital follow-up which would be confirmed with telephone call in special cases.
Timepoint [1] 295561 0
3 years,5 years

Eligibility
Key inclusion criteria
1.Histologically diagnosed as invasive breast cancer (T1-T3)
2.Clinical negative axillary lymph node
3.No distant metastasis
Minimum age
18 Years
Maximum age
85 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Histologically identified positive lymph node
2.Palpable positive lymph node
3.A positive history of anaphylaxis or iodine allergy
4.A history of axillary surgery

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by using a randomisation table generated by computer.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Open to recruitment
Date of first participant enrolment
Anticipated
5/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 289006 0
State/province [1] 289006 0

Funding & Sponsors
Funding source category [1] 284513 0
Government funding body e.g. Australian Research Council
Name [1] 284513 0
Capital Medical Developmental Fund
Country [1] 284513 0
China
Primary sponsor type
Hospital
Name
Peking University People's Hospital Breast Cancer Center
Address
Peking University People's Hospital Breast Cancer Center,No 11 Xizhimen South Street,Beijing 100044
Country
China
Secondary sponsor category [1] 283449 0
Government funding body e.g. Department of Health
Name [1] 283449 0
Beijing Municipal Health Bureau
Address [1] 283449 0
Building B, Zhonghuan Square, Zaolinqian Street, Xuanwu District, Beijing 100053
Country [1] 283449 0
China

Ethics approval
Ethics application status
Yes
Ethics committee name [1] 286498 0
Peking University People's Hospital Ethics Committee
Ethics committee address [1] 286498 0
Peking University People's Hospital,No 11 Xizhimen South Street,Beijing 100044
Ethics committee country [1] 286498 0
China
Date submitted for ethics approval [1] 286498 0
01/06/2010
Approval date [1] 286498 0
01/09/2010
Ethics approval number [1] 286498 0

Summary
Brief summary
Methylene blue is widely used in developing country for SLNB.The ICG is an innovative fluorescent tracer that could be visualized by near-infrared camera.This trial is designed to compare the efficacy and Safety of Combined Use of ICG Fluorescence and Methylene Blue Dye versus dye alone for SLNB in Breast Cancer Patients.
Trial website
NA
Trial related presentations / publications
NA
Public notes

Contacts
Principal investigator
Contact person for public queries
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided
Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.