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

Mammary Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01522300
• Other study ID #: TOMOS
• Status: Terminated
• Phase: Phase 2
• First received: January 18, 2012
• Last updated: November 20, 2013
• Start date: January 2012
• Est. completion date: August 2013

Study information

• Verified date: November 2013
• Source: Centre Jean Perrin
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 81
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Neoplasms
• Mammary Tumor

Intervention

Other:
• Evaluation of the Tomosynthesis
An exam by tomosynthesis will be realised at the inclusion of the patient in the study.
• Avaluation of a medical device: the tomosynthesis
An exam by tomosynthesis will be realised at the inclusion of the patient in the study

Locations

Country	Name	City	State
France	Centre Jean Perrin	Clermont Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
Centre Jean Perrin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	January 2013	No