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

Etude Tomos- Apport de la Tomosynthèse Dans le Bilan d'Extension locorégional préthérapeutique d'Une Tumeur du Sein : Recherche de multicentricité

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01522300

Enrollment

Registered

2012-01-31

Start date

2012-01-31

Completion date

2013-08-31

Last updated

2013-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mammary Tumor

Keywords

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

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

Interventions

OTHEREvaluation of the Tomosynthesis

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

OTHERAvaluation of a medical device: the tomosynthesis

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	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.	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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026