Status:

WITHDRAWN

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

Lead Sponsor:

University of California, Irvine

Collaborating Sponsors:

Carestream Health, Inc.

Eastman Kodak Company

Conditions:

Breast Cancer

Eligibility:

FEMALE

40-85 years

Phase:

NA

Brief Summary

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 de...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    May 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2008

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00610831

    Start Date

    May 1 2007

    End Date

    June 1 2008

    Last Update

    January 31 2018

    Active Locations (1)

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    Breast Health Center, University of California Irvine Medical Center

    Orange, California, United States, 92868