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

This study has been completed.
Sponsor:
Collaborator:
Carestream Health, Inc.
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00610831
First received: January 12, 2008
Last updated: April 1, 2011
Last verified: April 2011
History of Changes
  Purpose

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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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
  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610831

Locations
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.
Investigators
Principal Investigator: Stephen Feig, MD University of California, Irvine
  More Information

No publications provided

Responsible Party: Stephen Feig, Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00610831     History of Changes
Other Study ID Numbers: UCI-HS-2007-5519, CH-41914
Study First Received: January 12, 2008
Last Updated: April 1, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013