Etude Tomos- Apport de la Tomosynthèse Dans le Bilan d'Extension locorégional préthérapeutique d'Une Tumeur du Sein : Recherche de multicentricité
18 Years
N/A
Female
Mammary Tumor
Trial Information
Etude Tomos- Apport de la Tomosynthèse Dans le Bilan d'Extension locorégional préthérapeutique d'Une Tumeur du Sein : Recherche de multicentricité
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
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
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.
Outcome Description:
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.
Outcome Time Frame:
January 2013
Safety Issue:
No
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
TOMOS
NCT ID:
NCT01522300
Start Date:
January 2012
Completion Date:
January 2013
Related Keywords:
- Mammary Tumor
- Tomosynthesis
- breast cancer
- specificity
- sensitivity
- To assess efficacy of Tomosynthesis by evaluating its sensitivity and specificity in detecting the multicentricity of mammary tumor
- Breast Neoplasms
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