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

University of California, Irvine

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Breast Cancer

Interventions

DIRECTVIEW CR MammographyDEVICE

4 views screening mammogram

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Breast Health Center, University of California Irvine Medical Center

Orange, California, United States

Outcomes

Primary Outcomes

To collect mammogram from patients with breast cancer using the Carestream Mammo CR device.

Time frame: at completion of the study

Data from ClinicalTrials.gov

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