International validation of AISmartDensity

Purpose and goal

We will carry out an international validation of the AI tool AISmartDensity, which was developed by researchers at Karolinska Institutet and the Royal Institute of Engineering. AISmartDensity identifies those who have undergone screening mammography without signs of cancer, and where an examination with a more sensitive radiological method should be added to rule out breast cancer. A clinical study showed excellent results, these need to be validated in retrospective cohorts in the US and UK.

Expected effects and result

Expected results is that we can show that AISmartDensity achieves similar accuracy in datasets from the UK and the USA, as we demonstrated at Karolinska in Sweden. The effect thereafter is to facilitate regulatory approval and subsequent clinical implementation. In the long run, this is expected to lead to earlier detection of breast cancer and improved survival.

Planned approach and implementation

First, a research agreement is established between KI and participating foreign parties. They then compile datasets of mammography images linked to clinical outcomes. After technical installation, we let AISmartDensity process the images and produce predictions. These predictions are analyzed statistically by the project parties, and we then compile the results. The results will be published in scientific journals and conferences, as well as discussed with various stakeholders in Sweden.