Trial Information

A Prospective Evaluation of Computer Aided Detection (CAD) in the NHS Breast Screening Programme [CADET II]

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.