Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450359
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2007-03-20
Brief Title:
Computer-Aided Breast Cancer Detection in Women Undergoing Screening Mammography
Sponsor:
Aberdeen Royal Infirmary
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Prospective Evaluation of Computer Aided Detection CAD in the NHS Breast Screening Programme CADET II
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ie 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 readers 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 30000 participants will be accrued for this study
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 ie 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 readers 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 30000 participants will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20709 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000534404 | REGISTRY | None | None |
| CRUK-CADET-II | None | None | None |
| ABROIN-CADET-II | None | None | None |