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IDENTIFICATION OF SENTINEL NODE(S) IN BREAST CANCER (SENTIMAG)

Primary Purpose

BREAST CANCER

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Excision of sentinel node(s)
Sponsored by
Centre Oscar Lambret
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for BREAST CANCER focused on measuring SENTINEL NODE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Centre Oscar Lambret
  • Centre Eugène Marquis
  • Institut Claudius Regaud
  • Centre Alexis Vautrin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Identification of sentinel node(s)

Arm Description

Outcomes

Primary Outcome Measures

Sentinel node(s)detected with new technical
Idenfication 's rate of sentinel nodes detected with new technical(SentiMag ® / Sienna + TM)

Secondary Outcome Measures

Detected node(s) for each method(standard and new)
Proportion of detected nodes for each method(standard and new)

Full Information

First Posted
February 8, 2013
Last Updated
March 5, 2014
Sponsor
Centre Oscar Lambret
Collaborators
Sysmex America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01790399
Brief Title
IDENTIFICATION OF SENTINEL NODE(S) IN BREAST CANCER
Acronym
SENTIMAG
Official Title
IDENTIFICATION OF SENTINEL NODE(S) BY SENTIMAG® /SIENNA+ IN BREAST CANCER: FEASIBILITY STUDY
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
Collaborators
Sysmex America, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Identification of Sentinel node(s) Step 1: Identification using the technique Nanocis Sub-areolar injection of Tc99m-Nanocis ® the day before or the day of surgery Step 2: Identification using the technique SentiMag ® / Sienna+ Injection Sienna + ™ should be done just after induction of anesthesia and before the injection of Patent Blue dye Step 3: Identification using the technique of Patent Blue Dye or Lymphotropic dye injection or Patent Blue is performed after induction of anesthesia, the injection and production Sienna + ™, the operating theater by the surgeon Detection of Sentinel node(s) Step 1: probe SentiMag ® (study) Step 2: hand probe gamma radiation detection and / or colorimetric detection (standard) Sentinel node's excision of radioactive and / or blue and / or magnetic (colored brown-brown) After the procedure: Characterization of the size and weight of lymph nodes, histological and / or molecular OSNA and linking nodal status with the detection rate of sentinel nodes for each technique. NB: In case of synchronous bilateral cancer, 2 records are possible

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BREAST CANCER
Keywords
SENTINEL NODE

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
115 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Identification of sentinel node(s)
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Excision of sentinel node(s)
Intervention Description
Excision of sentinel node(s) using SENTIMAG / SIENNA + in addition to the usual method (blue and /or radioactive product)
Primary Outcome Measure Information:
Title
Sentinel node(s)detected with new technical
Description
Idenfication 's rate of sentinel nodes detected with new technical(SentiMag ® / Sienna + TM)
Time Frame
The day of surgery
Secondary Outcome Measure Information:
Title
Detected node(s) for each method(standard and new)
Description
Proportion of detected nodes for each method(standard and new)
Time Frame
The day of surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Louis MD HOUPEAU
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Study Director
Facility Information:
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Eugène Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31 052
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre les nancy
ZIP/Postal Code
54 511
Country
France

12. IPD Sharing Statement

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IDENTIFICATION OF SENTINEL NODE(S) IN BREAST CANCER

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