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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

This study is currently recruiting participants.
Verified January 2012 by Centre Jean Perrin
Sponsor:
Information provided by (Responsible Party):
Centre Jean Perrin
ClinicalTrials.gov Identifier:
NCT01522300
First received: January 18, 2012
Last updated: January 27, 2012
Last verified: January 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Mammary Tumor
 Other: Evaluation of the Tomosynthesis
Other: Avaluation of a medical device: the tomosynthesis
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Etude Tomos- Apport de la Tomosynthèse Dans le Bilan d'Extension locorégional préthérapeutique d'Une Tumeur du Sein : Recherche de multicentricité

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Jean Perrin:

Primary Outcome Measures:
  • 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. [ Time Frame: January 2013 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Evaluation of the Tomosynthesis
    An exam by tomosynthesis will be realised at the inclusion of the patient in the study.
    Other: Avaluation of a medical device: the tomosynthesis
    An exam by tomosynthesis will be realised at the inclusion of the patient in the study
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522300

Locations
France
Centre Jean Perrin Recruiting
Clermont Ferrand, France, 63011
Contact: Sylvie Lemery, MD     (33) 4 73 27 81 81     Sylvie.LEMERY@cjp.fr    
Contact: Catherine Abrial, PhD     (33) 4 73 27 84 91     Catherine.ABRIAL@cjp.fr    
Principal Investigator: Sylvie Lemery, MD            
Sub-Investigator: Valérie Dieu, MD            
Sub-Investigator: Véronique Boussion, MD            
Sub-Investigator: Anne Bailly, MD            
Sponsors and Collaborators
Centre Jean Perrin
  More Information

No publications provided

Responsible Party: Centre Jean Perrin
ClinicalTrials.gov Identifier: NCT01522300     History of Changes
Other Study ID Numbers: TOMOS
Study First Received: January 18, 2012
Last Updated: January 27, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by Centre Jean Perrin:
Tomosynthesis
breast cancer
specificity
sensitivity
To assess efficacy of Tomosynthesis by evaluating its sensitivity and specificity in detecting the multicentricity of mammary tumor

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013