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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

Primary Purpose

Mammary Tumor

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Evaluation of the Tomosynthesis
Avaluation of a medical device: the tomosynthesis
Sponsored by
Centre Jean Perrin
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Mammary Tumor focused on measuring Tomosynthesis, breast cancer, specificity, sensitivity, To assess efficacy of Tomosynthesis by evaluating its sensitivity and specificity in detecting the multicentricity of mammary tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Centre Jean Perrin

Outcomes

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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 18, 2012
Last Updated
November 20, 2013
Sponsor
Centre Jean Perrin
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1. Study Identification

Unique Protocol Identification Number
NCT01522300
Brief Title
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
Official Title
Etude Tomos- Apport de la Tomosynthèse Dans le Bilan d'Extension locorégional préthérapeutique d'Une Tumeur du Sein : Recherche de multicentricité
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
No more inclusions since august 2013
Study Start Date
January 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Jean Perrin

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Evaluation of the Tomosynthesis
Intervention Description
An exam by tomosynthesis will be realised at the inclusion of the patient in the study.
Intervention Type
Other
Intervention Name(s)
Avaluation of a medical device: the tomosynthesis
Intervention Description
An exam by tomosynthesis will be realised at the inclusion of the patient in the study
Primary Outcome Measure Information:
Title
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.
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. The other parameters VPN, VPP will also be calculated and discussed.
Time Frame
January 2013

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Centre Jean Perrin
City
Clermont Ferrand
ZIP/Postal Code
63011
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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