Artificial Intelligence in BreastScreen Norway - a Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this randomized controlled trial is to compare the number of breast cancers detected among women who had their screening mammograms interpreted by artificial intelligence (AI) in combination with one or two breast radiologists to the number of breast cancers detected after standard independent double reading in BreastScreen Norway. The aims of the study is to prove that screening interpretation with AI in combination with one or two radiologists (the intervention) is non-inferior to standard interpretation procedure.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 50
Maximum Age: 69
Healthy Volunteers: t
View:
• Women attending the population-based mammography screening program BreastScreen Norway providing a signed, informed consent
Locations
Other Locations
Norway
Cancer Registry of Norway, Norwegian Institute of Public Health
RECRUITING
Oslo
Contact Information
Primary
Solveig Hofvind, PhD
sshh@kreftregisteret.no
22928828
Backup
Åsne S Holen, MSc
asho@kreftregisteret.no
Time Frame
Start Date: 2024-11-25
Estimated Completion Date: 2033-06
Participants
Target number of participants: 150000
Treatments
Experimental: Intervention arm
AI assisted mammography screening interpretation
Active_comparator: Control arm
Standard mammography screening interpretation (standard procedure)
Related Therapeutic Areas
Sponsors
Leads: Norwegian Institute of Public Health
Collaborators: Helse Midt-Norge, Helse Nord, Norwegian Cancer Society, Helse Vest