Computer-Aided Breast Cancer Detection in Women Undergoing Screening Mammography
|ClinicalTrials.gov Identifier: NCT00450359|
Recruitment Status : Completed
First Posted : March 22, 2007
Last Update Posted : August 2, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: breast imaging study Procedure: comparison of screening methods Procedure: radiomammography||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30000 participants|
|Official Title:||A Prospective Evaluation of Computer Aided Detection (CAD) in the NHS Breast Screening Programme [CADET II]|
|Study Start Date :||September 2006|
|Actual Study Completion Date :||October 2008|
- Breast cancer detection rate
- Recall rate
- Film reader performance using computer-aided detection
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00450359
|Coventry, England, United Kingdom, CV2 2DX|
|Manchester, England, United Kingdom, M20 8LR|
|Nottingham City Hospital NHS Trust|
|Nottingham, England, United Kingdom, NG5 1PB|
|Aberdeen Royal Infirmary|
|Aberdeen, Scotland, United Kingdom, AB25 2ZN|
|Study Chair:||Fiona Gilbert, MD||Aberdeen Royal Infirmary|