An interventional study of AI CAD and Radiologist reading in Breast Neoplasm Female, sponsored by Karolinska University Hospital. Status unknown at 1 site in Sweden. Open to female participants aged 40 Years to 74 Years. Per ClinicalTrials.gov, last updated 2023-03-14.
Sponsored by Karolinska University Hospital · Not applicable, Interventional, and Diagnostic
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.
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 55,579 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Karolinska University Hospital is the lead sponsor of 275 studies on the registry; 54 are open to participants now.
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Exclusion Criteria:
Standard of Care means all examinations will receive a flagging decision by: first reader and second reader radiologist as usual. However, in this paired design all participants will belong to both arms.
Diagnostic Test: Radiologist reading
AI CAD combination in the primary end-point means the combination of the flagging decision of the first reader and AI CAD; in the secondary end-points it means any combination of AI alone, or AI in combination with first, second and both readers.
Diagnostic Test: AI CAD · Diagnostic Test: Radiologist reading
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.
Also known as: Lunit INSIGHT MMG
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)
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
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — To the extent allowed by source institution, legal agreements, and applicable laws and regulations
Supporting information: Study protocol, Sap
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Karolinska University Hospital