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Computed Radiography (CR) Data Collection for Mammography Computer Aided Detection (CAD)

This study has been completed.
Carestream Health, Inc.
Information provided by:
University of California, Irvine Identifier:
First received: January 12, 2008
Last updated: April 1, 2011
Last verified: April 2011
The objective of this study is to collect an image library of diagnostic digital mammograms using the Carestream CR mammography system from patients who have histological-conformed breast cancer to demonstrate the clinical feasibility of this system for detection of breast cancer.

Condition Intervention
Breast Cancer
Device: DIRECTVIEW CR Mammography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Computed Radiography (CR) Data Collection for Mammography Computer Aided Detection (CAD)

Resource links provided by NLM:

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • To collect mammogram from patients with breast cancer using the Carestream Mammo CR device. [ Time Frame: at completion of the study ]

Enrollment: 0
Study Start Date: May 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: DIRECTVIEW CR Mammography
    4 views screening mammogram

Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Requirements

  • Women age 40 to 85
  • Recommended for biopsy and BI-RADS assessment of category 4 (suspicious abnormality) or 5 (highly suggestive of malignancy)
  • Able to have MLO and CC views taken
  • Good general health
  • Able and willing to provide a written Informed Consent

Exclusion Requirements

  • Under age 40
  • Pregnant or suspicious of being pregnant
  • Breast implants
  • Breasts too large to be adequately positioned on a 24 x 30 cassette
  • Personal history of breast cancer treated with a lumpectomy
  • Unable or unwilling to provide a written Informed Consent form
  Contacts and Locations
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Please refer to this study by its identifier: NCT00610831

United States, California
Breast Health Center, University of California Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Carestream Health, Inc.
Principal Investigator: Stephen Feig, MD University of California, Irvine
  More Information

Responsible Party: Stephen Feig, Professor, University of California, Irvine Identifier: NCT00610831     History of Changes
Other Study ID Numbers: UCI-HS-2007-5519
Study First Received: January 12, 2008
Last Updated: April 1, 2011 processed this record on May 22, 2017