IDENTIFICATION OF SENTINEL NODE(S) IN BREAST CANCER
SENTIMAG
1 other identifier
interventional
115
1 country
4
Brief Summary
The study is based on the identification of sentinel node(s) by SENTIMAG / SIENNA + in addition to the usual method (blue and /or radioactive product). This is a feasibility study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Jan 2013
Shorter than P25 for not_applicable breast-cancer
4 active sites
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
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 8, 2013
CompletedFirst Posted
Study publicly available on registry
February 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedMarch 6, 2014
August 1, 2013
1.1 years
February 8, 2013
March 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sentinel node(s)detected with new technical
Idenfication 's rate of sentinel nodes detected with new technical(SentiMag ® / Sienna + TM)
The day of surgery
Secondary Outcomes (1)
Detected node(s) for each method(standard and new)
The day of surgery
Study Arms (1)
Identification of sentinel node(s)
EXPERIMENTALInterventions
Excision of sentinel node(s) using SENTIMAG / SIENNA + in addition to the usual method (blue and /or radioactive product)
Eligibility Criteria
You may qualify if:
- Patient with invasive breast cancer or microinfiltrant proven by cytology and histo-or whatever the histological type
- cT0/cT1/cT2 (up to 5 cm) CN0 clinical and / or ultrasound and without prior treatment (chemotherapy or neoadjuvant hormone )
- Age greater than or equal to 18
- Reporting of breast surgery and axillary staging of sentinel lymph node
- Using effective contraception (BHCG negative)
- Patient affiliated with a health insurance
- Consent signed by the patient
You may not qualify if:
- T3 or T4 tumors (\> 5 cm, cutaneous or muscle inflammation or cancer)
- Presence of a clinically suspicious axillary adenopathy or imaging
- Tumors bifocal or multifocal known before Surgery
- History of breast surgery or axillary
- Patient metastatic
- Patient with a cons-indication anesthesia and / or surgery
- Intolerance or hypersensitivity to the compounds or iron dextran or superparamagnetic iron oxide or to Patent blue dye in centers where it is commonly used
- Patient can not receive a radioactive isotope to the sentinel lymph node resection
- Allergy radioactive product
- Chronic iron overload
- Pacemaker or other implantable device in the chest wall
- Failure to submit to medical study for geographical, social or psychological
- Patient deprived of liberty or under guardianship
- Pregnant or lactating
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Oscar Lambretlead
- Sysmex America, Inc.collaborator
Study Sites (4)
Centre Oscar Lambret
Lille, 59020, France
Centre Eugène Marquis
Rennes, 35042, France
Institut Claudius Regaud
Toulouse, 31 052, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54 511, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jean-Louis MD HOUPEAU
Centre Oscar Lambret
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2013
First Posted
February 13, 2013
Study Start
January 1, 2013
Primary Completion
February 1, 2014
Study Completion
July 1, 2014
Last Updated
March 6, 2014
Record last verified: 2013-08