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 2

Terminated

• Conditions: Mammary Tumor

• Registration Number: NCT01522300
• Lead Sponsor: Centre Jean Perrin

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

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-27
• Study First Posted: 2012-01-31
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-20
• Last Update Posted: 2013-11-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	January 2013	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.

Trial Locations

Locations (1)

Centre Jean Perrin; 🇫🇷 Clermont Ferrand, France