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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

NCT ID: NCT01522300

Last Updated: 2013-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-08-31

Brief Summary

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

Detailed Description

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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

Conditions

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Mammary Tumor

Keywords

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Tomosynthesis breast cancer specificity sensitivity To assess efficacy of Tomosynthesis by evaluating its sensitivity and specificity in detecting the multicentricity of mammary tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Evaluation of the Tomosynthesis

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

Intervention Type OTHER

Avaluation of a medical device: the tomosynthesis

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Jean Perrin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Jean Perrin

Clermont-Ferrand, , France

Site Status

Countries

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France

Other Identifiers

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TOMOS

Identifier Type: -

Identifier Source: org_study_id