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

University of California Irvine (UCI)

Status: Withdrawn

Conditions: Breast Cancer

Treatments: Device: DIRECTVIEW CR Mammography

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00610831

CH-41914 (Other Grant/Funding Number)

UCI-HS-2007-5519

Details and patient eligibility

About

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.

Sex: Female

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

DirectView CR Mammography

Experimental group

Description:

Each subject will have routine clinical care imaging obtained and 4 standard mammogram views (RMLO, RCC, LMLO, LCC) using CR mammography. If routine mammograms were obtained on a day previous to enrollment in the study, those images (4 views; 2 views for mastectomy patients) will not be repeated for this study; only the CR images will be obtained.

Treatment:

Device: DIRECTVIEW CR Mammography