Computer-Aided Breast Cancer Detection in Women Undergoing Screening Mammography
NCT ID: NCT00450359
Last Updated: 2013-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30000 participants
INTERVENTIONAL
2006-09-30
2008-10-31
Brief Summary
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PURPOSE: This randomized clinical trial is studying how well computer-aided breast cancer detection works in women undergoing screening mammography.
Detailed Description
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* 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
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Keywords
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Study Design
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RANDOMIZED
SCREENING
Interventions
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breast imaging study
comparison of screening methods
radiomammography
Eligibility Criteria
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Inclusion Criteria
* 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
PATIENT CHARACTERISTICS:
* Female
* Menopausal status not specified
PRIOR CONCURRENT THERAPY:
* Not specified
50 Years
70 Years
FEMALE
Yes
Sponsors
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Aberdeen Royal Infirmary
OTHER
Principal Investigators
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Fiona Gilbert, MD
Role: STUDY_CHAIR
Aberdeen Royal Infirmary
Locations
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Walsgrave Hospital
Coventry, England, United Kingdom
Withington Hospital
Manchester, England, United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Countries
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References
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James JJ, Gilbert FJ, Wallis MG, Gillan MG, Astley SM, Boggis CR, Agbaje OF, Brentnall AR, Duffy SW. Mammographic features of breast cancers at single reading with computer-aided detection and at double reading in a large multicenter prospective trial of computer-aided detection: CADET II. Radiology. 2010 Aug;256(2):379-86. doi: 10.1148/radiol.10091899.
Gilbert FJ, Astley SM, Gillan MG, Agbaje OF, Wallis MG, James J, Boggis CR, Duffy SW; CADET II Group. Single reading with computer-aided detection for screening mammography. N Engl J Med. 2008 Oct 16;359(16):1675-84. doi: 10.1056/NEJMoa0803545. Epub 2008 Oct 1.
Other Identifiers
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CDR0000534404
Identifier Type: REGISTRY
Identifier Source: secondary_id
CRUK-CADET-II
Identifier Type: -
Identifier Source: secondary_id
ABROIN-CADET-II
Identifier Type: -
Identifier Source: secondary_id
EU-20709
Identifier Type: -
Identifier Source: secondary_id
ABROIN-06-MRE01-14
Identifier Type: -
Identifier Source: org_study_id