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

Centre Jean Perrin

Status and phase: Terminated; Phase 2

Conditions: Mammary Tumor

Treatments: Other: Avaluation of a medical device: the tomosynthesis; Other: Evaluation of the Tomosynthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT01522300

TOMOS

Details and patient eligibility

About

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

Full 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

Enrollment: 81 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)