At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Single-blinded, Controlled Trial on the Efficacy of Mammography Screening With Artificial Intelligence - the MASAI Study
In Brief
A clinical study evaluating AI screening modality and Conventional screening modality for Breast Cancer. Completed, enrolled 100,000 participants across 1 site.
Detailed Summary
The purpose of this randomized controlled trial is to assess whether AI can improve the efficacy of mammography screening, by adapting single and double reading based on AI derived cancer-risk scores and to use AI as a decision support in the screen reading, compared with conventional mammography screening (double reading without AI).
Study Details
Timeline
Interventions
Screen exam will be analysed with an AI system (Transpara, ScreenPoint, Nijmegen, The Netherlands) that assigns exams with a cancer-risk score from 1 to 10, as well as presenting CAD-marks at suspicious findings. Exams with risk score 1-9 will be single read and exam with score 10 will be double read. Risk scores and CAD-marks are provided to the reader(s). The reader(s) will decide whether to recall the woman for work-up or not (as per standard of care). In addition, exams with the highest 1% risk will by default be recalled with the exception of obvious false positives.
Screen exams will be read by two radiologists without the support of AI.