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Computer-Aided Breast Cancer Detection in Women Undergoing Screening Mammography

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00450359
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 ClinicalTrials.gov 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.

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.

Interventional
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30000
October 2008
Not Provided

DISEASE CHARACTERISTICS:

  • 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
Female
50 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00450359
ABROIN-06-MRE01-14, CDR0000534404, CRUK-CADET-II, ABROIN-CADET-II, EU-20709
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