- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01522300
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
November 20, 2013 updated by: Centre Jean Perrin
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
81
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Clermont Ferrand, France, 63011
- Centre Jean Perrin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
January 18, 2012
First Submitted That Met QC Criteria
January 27, 2012
First Posted (Estimate)
January 31, 2012
Study Record Updates
Last Update Posted (Estimate)
November 21, 2013
Last Update Submitted That Met QC Criteria
November 20, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TOMOS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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