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
  Purpose

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 Intervention
Breast Cancer
Procedure: breast imaging study
Procedure: comparison of screening methods
Procedure: radiomammography

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Screening
Official Title: A Prospective Evaluation of Computer Aided Detection (CAD) in the NHS Breast Screening Programme [CADET II]

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Breast cancer detection rate [ Designated as safety issue: No ]
  • Recall rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Film reader performance using computer-aided detection [ Designated as safety issue: No ]

Estimated Enrollment: 30000
Study Start Date: September 2006
Study Completion Date: October 2008
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.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00450359

Locations
United Kingdom
Walsgrave Hospital
Coventry, England, United Kingdom, CV2 2DX
Withington Hospital
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
Sponsors and Collaborators
Aberdeen Royal Infirmary
Investigators
Study Chair: Fiona Gilbert, MD Aberdeen Royal Infirmary
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00450359     History of Changes
Other Study ID Numbers: ABROIN-06-MRE01-14, CDR0000534404, CRUK-CADET-II, ABROIN-CADET-II, EU-20709
Study First Received: March 20, 2007
Last Updated: August 1, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 26, 2014