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Clinical Trials in Norway / NCT06032390
Recruiting Not applicable

Artificial Intelligence in Mammography Screening in Norway

NCT06032390 · tracked via the Priya Life Science Norway tracker
Sponsor
Norwegian Institute of Public Health
Phase
Not applicable
Started
2024-11-25
Last updated
2026-01-14

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

AI assisted mammography screening interpretationStandard mammography screening interpretation

AI assisted mammography screening interpretation: Screening examinations will be analyzed by the AI system (Transpara, ScreenPoint Medical, Nijmegen, The Netherlands) that assigns each examination a cancer risk score 1-10. Examinations with a score 1-7 will be single read and examinations with score 8-10 will be double read. Examinations selected by one or two readers will be discussed in a consensus meeting. Examinations with an AI score of \>9.8 will be selected for the consensus meeting by default. AI risk scores and image markings are provided to the readers only in the consensus meetings. The readers will decide whether to recall the woman for further assessment in consensus (standard procedure).

Standard mammography screening interpretation: Screening examinations will be assessed according to standard of care: independently double read, examinations selected by one or two readers will be discussed in a consensus meeting, and the radiologists will decide whether to recall the woman for further assessment. Screening examinations will be analyzed by the AI system retrospectively but the results will not be made available to the radiologist, only used for comparison to the intervention group in results analyses.

Study 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

Sex
FEMALE
Min age
50 Years
Max age
69 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Women attending the population-based mammography screening program BreastScreen Norway providing a signed, informed consent Exclusion Criteria: * Women attending the population-based mammography screening program BreastScreen Norway not providing a signed, informed consent

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Cancer Registry of Norway, Norwegian Institute of Public Health Oslo Norway Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06032390 on ClinicalTrials.gov ↗ ← All trials in Norway