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 has been terminated.
(No more inclusions since august 2013)
Sponsor:
Information provided by (Responsible Party):
Centre Jean Perrin
ClinicalTrials.gov Identifier:
NCT01522300
First received: January 18, 2012
Last updated: November 20, 2013
Last verified: November 2013

January 18, 2012
November 20, 2013
January 2012
August 2013   (final data collection date for primary 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. [ 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.
Same as current
Complete list of historical versions of study NCT01522300 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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

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
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Mammary Tumor
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
81
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01522300
TOMOS
No
Centre Jean Perrin
Centre Jean Perrin
Not Provided
Not Provided
Centre Jean Perrin
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP