This is a prospective clinical trial following a paired screen-positive design, with the aims to assess the performance of an artificial intelligence (AI) computer-aided detection (CAD) algorithm as an independent reader, in addition to two radiologists, of screening mammograms in a true screening population. Since all decisions by individual readers will be recorded, it is possible to determine what the outcome would have been had one or two of the readers not been allowed to assess images, and to determine what the outcome would have been had the recall decision been performed by consensus decision (actual) compared to single reader arbitration of discordant cases.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
55,579
The Lunit INSIGHT MMG will be used as the AI CAD in our study. Initially, version 1.6.1.1 will be installed. The software version will be continuously updated with subsequent software releases, after confirming in a historic calibration dataset that the performance is improved. The operating point will be set based on a historic calibration dataset to attain a joint sensitivity of breast cancer detection of AI and first reader which is 2% higher than for first and second reader.
Standard of care, each radiologist will assess the mammography examination, making a binary flagging decision (flag the examination to continue to consensus discussion, or not)
Capio St Göran Hospital
Stockholm, Sweden
Incident breast cancer
Breast cancer diagnosis by pathologist
Time frame: At Screening
Incident breast cancer
Breast cancer diagnosis by pathologist
Time frame: Within 12 months after screening
Incident breast cancer
Breast cancer diagnosis by pathologist
Time frame: Within 23 months after screening
Reader flagging
Radiologist or AICAD assessing the mammograms as suspicious or not suspicious for malignancy
Time frame: At screening
Consensus recall
A decision by the consensus discussion to recall the woman for further work-up
Time frame: At screening
Tissue sampling
Biopsy or fine needle aspiration performed
Time frame: At screening
Process failure
Failure of the AI CAD software to generate AI scores
Time frame: At screening
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