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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01928992
Recruitment Status : Completed
First Posted : August 27, 2013
Last Update Posted : November 21, 2016
Sponsor:
Information provided by (Responsible Party):
Fujifilm Medical Systems USA, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment
Breast Cancer Device: 3D Device: 2D

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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
Study Start Date : March 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Subjects with screening and diagnostic 3D or 2D mammography
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928992


Locations
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United States, Pennsylvania
ACR / Image Metrix
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Fujifilm Medical Systems USA, Inc.
Investigators
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Principal Investigator: Carl D'Orsi, MD Emory University
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Responsible Party: Fujifilm Medical Systems USA, Inc.
ClinicalTrials.gov Identifier: NCT01928992    
Other Study ID Numbers: FMSU2011-003B
First Posted: August 27, 2013    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: November 2016
Keywords provided by Fujifilm Medical Systems USA, Inc.:
Mammography
3D
Breast Cancer Detection
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases