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Pilot 3D Mammography Reader Study to Assess Breast Cancer Detection in 3D Versus 2D Digital Mammography

NCT ID: NCT01928992

Last Updated: 2016-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-06-30

Brief Summary

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The purpose of this pilot study is to provide credible performance estimate information in order to properly plan, design, and power a larger clinical study.

Detailed Description

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Conditions

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Breast Cancer

Keywords

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Mammography 3D Breast Cancer Detection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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3D

Subjects that undergo 3D mammography

3D

Intervention Type DEVICE

subjects that underwent 3D mammography

2D

Subjects that undergo 2D mammography

2D

Intervention Type DEVICE

those subjects that underwent 2D mammography

Interventions

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3D

subjects that underwent 3D mammography

Intervention Type DEVICE

2D

those subjects that underwent 2D mammography

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Female subjects participating in prior FMSU protocol with known clinical status

Exclusion Criteria

* Subjects with unkown clinical status
* Subjects not truthed in prior FMSU study
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fujifilm Medical Systems USA, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carl D'Orsi, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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ACR / Image Metrix

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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FMSU2011-003B

Identifier Type: -

Identifier Source: org_study_id