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

November 18, 2016 updated by: Fujifilm Medical Systems USA, Inc.

A Multi-reader, Multi-case, Controlled Clinical Trial to Evaluate the Fuji Film 3D Digital Mammography System Used in Conjunction With 2D Digital Mammography in the Detection of Breast Cancer / A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

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

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19103
        • ACR / Image Metrix

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

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Subjects with screening and diagnostic 3D or 2D mammography

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
3D
Subjects that undergo 3D mammography
Device: 3D
subjects that underwent 3D mammography
2D
Subjects that undergo 2D mammography
Device: 2D
those subjects that underwent 2D mammography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Per Breast AUC
Time Frame: 1 Day
Breast AUC performance metrics to determine if 3D has improved breast cancer detection rate as compared to 2D.
1 Day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject Recall Rate
Time Frame: 1 Day
For Cancer and Non-Cancer Cases to determine if 3D can reduce the need for follow-up mammography and/or improve time to determination of need for a biopsy
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujifilm Medical Systems USA, Inc.

Investigators

  • Principal Investigator: Carl D'Orsi, MD, Emory University

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

March 1, 2013

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

March 1, 2013

First Submitted That Met QC Criteria

August 22, 2013

First Posted (ESTIMATE)

August 27, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 21, 2016

Last Update Submitted That Met QC Criteria

November 18, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMSU2011-003B

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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