NCT01522300

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 31, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

November 21, 2013

Status Verified

November 1, 2013

Enrollment Period

1.6 years

First QC Date

January 18, 2012

Last Update Submit

November 20, 2013

Conditions

Mammary Tumor

Keywords

Tomosynthesisbreast cancerspecificitysensitivityTo assess efficacy of Tomosynthesis by evaluating its sensitivity and specificity in detecting the multicentricity of mammary tumor

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Evaluation of the TomosynthesisOTHER

An exam by tomosynthesis will be realised at the inclusion of the patient in the study.

Avaluation of a medical device: the tomosynthesisOTHER

An exam by tomosynthesis will be realised at the inclusion of the patient in the study

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

MeSH Terms

Conditions

Breast NeoplasmsHypersensitivity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2012

First Posted

January 31, 2012

Study Start

January 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

November 21, 2013

Record last verified: 2013-11

Locations

FR(1)