Etude Tomos- Apport de la Tomosynthèse Dans le Bilan d'Extension locorégional préthérapeutique d'Une Tumeur du Sein : Recherche de multicentricité Tomos Study- Contribution of Tomosynthesis In Locoregional Pretherapeutic Staging of a Breast Tumor: Multicentricity Search

Study Overview
=================
Brief Summary
-----------------
The main objective of the study is to assess the sensitivity and specificity of Tomosynthesis in detecting the multicentricity of mammary tumor.

Detailed Description
-----------------
The secondaries objectives of the study are: Sensitivity and specificity in detecting multifocality of breast tumor Sensitivity and specificity of Tomosynthesis in the detection of contralateral tumors Predetermination of potential targets for ultrasound

Official Title
-----------------
Etude Tomos- Apport de la Tomosynthèse Dans le Bilan d'Extension locorégional préthérapeutique d'Une Tumeur du Sein : Recherche de multicentricité

Conditions
-----------------
Mammary Tumor

Intervention / Treatment
-----------------
* Other: Evaluation of the Tomosynthesis
* Other: Avaluation of a medical device: the tomosynthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age> 18 years. Patients with a breast tumor, regardless of the stage and size Compulsory affiliation to a social security system. Obtaining informed consent in writing, signed and dated. Exclusion Criteria: Patients with cognitive or psychiatric disorders. Patient deprived of liberty by a court or administrative. Patients with indications against the achievement of MRI, mammography and tomosynthesis Pregnant Women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Evaluation of the Tomosynthesis|An exam by tomosynthesis will be realised at the inclusion of the patient in the study.|
|Other: Avaluation of a medical device: the tomosynthesis|An exam by tomosynthesis will be realised at the inclusion of the patient in the study|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To calculate the sensitivity and specificity of both types of imaging (mammography and Tomosynthesis) with respect to number of tumors multicentric and multifocal identified through MRI. | To calculate the sensitivity and specificity of both types of imaging (mammography and Tomosynthesis) with respect to number of tumors multicentric and multifocal identified through MRI. The other parameters VPN, VPP will also be calculated and discussed. | January 2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tomosynthesis, breast cancer, specificity, sensitivity, To assess efficacy of Tomosynthesis by evaluating its sensitivity and specificity in detecting the multicentricity of mammary tumor