Computed Radiography (CR) Data Collection for Mammography Computer Aided Detection (CAD)
N/A
40 Years
85 Years
40 Years
85 Years
Not Enrolling
Female
Breast Cancer
Female
Breast Cancer
Trial Information
Computed Radiography (CR) Data Collection for Mammography Computer Aided Detection (CAD)
Inclusion 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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
To collect mammogram from patients with breast cancer using the Carestream Mammo CR device.
Outcome Time Frame:
at completion of the study
Safety Issue:
No
Principal Investigator
Stephen Feig, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of California, Irvine
Authority:
United States: Institutional Review Board
Study ID:
UCI-HS-2007-5519
NCT ID:
NCT00610831
Start Date:
May 2007
Completion Date:
June 2008
Related Keywords:
- Breast Cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Breast Health Center, University of California Irvine Medical Center | Orange, California 92868 |
