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


N/A
40 Years
85 Years
Not Enrolling
Female
Breast Cancer

Thank you

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 CenterOrange, California  92868