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

C

Centre Oscar Lambret

Status

Unknown

Conditions

BREAST CANCER

Treatments

Procedure: Excision of sentinel node(s)

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01790399
SENTIMAG-1213

Details and patient eligibility

About

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

Full 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

Enrollment

115 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

115 participants in 1 patient group

Identification of sentinel node(s)
Experimental group
Treatment:
Procedure: Excision of sentinel node(s)

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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