Computer-Aided Breast Cancer Detection in Women Undergoing Screening Mammography
- Conditions
- Breast Cancer
- Registration Number
- NCT00450359
- Lead Sponsor
- Aberdeen Royal Infirmary
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 30000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Breast cancer detection rate Recall rate
- Secondary Outcome Measures
Name Time Method Film reader performance using computer-aided detection
Trial Locations
- Locations (4)
Walsgrave Hospital
🇬🇧Coventry, England, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Scotland, United Kingdom
Withington Hospital
🇬🇧Manchester, England, United Kingdom
Nottingham City Hospital NHS Trust
🇬🇧Nottingham, England, United Kingdom