Computer-Aided Breast Cancer Detection in Women Undergoing Screening Mammography

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: March 20, 2007
Last updated: August 1, 2013
Last verified: October 2008

March 20, 2007
August 1, 2013
September 2006
Not Provided
  • Breast cancer detection rate [ Designated as safety issue: No ]
  • Recall rate [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00450359 on Archive Site
Film reader performance using computer-aided detection [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
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]

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.


  • 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.

Not Provided
Allocation: Randomized
Primary Purpose: Screening
Breast Cancer
  • Procedure: breast imaging study
  • Procedure: comparison of screening methods
  • Procedure: radiomammography
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2008
Not Provided


  • Currently undergoing 2-view mammography for routine breast cancer screening at any of the following participating National Health Services Breast Cancer Screening Program centers:

    • Manchester
    • Coventry
    • Nottingham
  • Hormone receptor status not specified


  • Female
  • Menopausal status not specified


  • Not specified
50 Years to 70 Years
Contact information is only displayed when the study is recruiting subjects
United Kingdom
Not Provided
Not Provided
Aberdeen Royal Infirmary
Not Provided
Study Chair: Fiona Gilbert, MD Aberdeen Royal Infirmary
National Cancer Institute (NCI)
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP