NCT00450359

Computer-Aided Breast Cancer Detection in Women Undergoing Screening Mammography

A Prospective Evaluation of Computer Aided Detection (CAD) in the NHS Breast Screening Programme [CADET II]

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30,000 (estimated)
• Sponsor: Aberdeen Royal Infirmary · Academic / Other
• Sex: Female
• Age: 50 Years – 70 Years
• Healthy volunteers: Accepted

Summary

RATIONALE: A computer-aided detection program may help doctors find breast cancer sooner, when it may be easier to treat, in women undergoing screening mammography. PURPOSE: This randomized clinical trial is studying how well computer-aided breast cancer detection works in women undergoing screening mammography.

Detailed description

OBJECTIVES: * Compare, prospectively, the breast cancer detection rate and recall rate of single reading using computer-aided detection vs standard double reading in women undergoing screening mammography. OUTLINE: This is a prospective, randomized, multicenter study. Participants are randomized to 1 of 3 screening arms. * Arm I (double reading): Screening mammograms are independently reviewed by two readers (i.e., radiologist or radiographer), each of whom reports on any abnormalities and decides whether a participant is recalled for further assessment or returned home to routine screening. In the event there is disagreement between the readers' findings, a third reader acts as an arbitrator by rendering an interpretation of the mammogram and making the final decision to recall the participant or return to routine screening. * Arm II (single reading with computer-aided detection \[CAD\]): Screening mammograms are reviewed initially by a single reader who reports on any abnormalities. The reader then re-examines the mammogram with the aid of CAD, a system that uses computer prompts to recall suspicious features or abnormalities that may have been overlooked or previously dismissed as being normal. Based on these evaluations, a recommendation is made by the reader to either recall the participant for further assessment or return home to routine screening. If there is a discrepancy between the reader's interpretation and the CAD findings, another reader may be consulted to review the mammogram. * Arm III (double reading followed by single reading with CAD): Screening mammograms are reviewed by double reading as in arm I followed by single reading with CAD as in arm II. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 30,000 participants will be accrued for this study.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	breast imaging study
PROCEDURE	comparison of screening methods
PROCEDURE	radiomammography

Timeline

• Start date: 2006-09-01
• Completion: 2008-10-01
• First posted: 2007-03-22
• Last updated: 2013-08-02

Locations

4 sites across 1 country: United Kingdom