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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00610831
• Other study ID #: UCI-HS-2007-5519
• Secondary ID: CH-41914
• Status: Withdrawn
• Phase: N/A
• First received: January 12, 2008
• Last updated: January 29, 2018
• Start date: May 2007
• Est. completion date: June 2008

Study information

• Verified date: January 2018
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 demonstrate the clinical feasibility of this system for detection of breast cancer.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• DIRECTVIEW CR Mammography
4 views screening mammogram

Locations

Country	Name	City	State
United States	Breast Health Center, University of California Irvine Medical Center	Orange	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Irvine	Carestream Health, Inc., Eastman Kodak Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To collect mammogram from patients with breast cancer using the Carestream Mammo CR device.		at completion of the study