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

Phase 2TerminatedNCT01522300

Centre Jean Perrin81 enrolled

Overview

The main objective of the study is to assess the sensitivity and specificity of Tomosynthesis in detecting the multicentricity of mammary tumor.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Mammary Tumor

Interventions

Evaluation of the TomosynthesisOTHER

An exam by tomosynthesis will be realised at the inclusion of the patient in the study.

Avaluation of a medical device: the tomosynthesisOTHER

An exam by tomosynthesis will be realised at the inclusion of the patient in the study

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre Jean Perrin

Clermont-Ferrand, France

Outcomes

Primary Outcomes

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.

Time frame: January 2013

Data from ClinicalTrials.gov

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