Artificial Intelligence in Mammography Screening in Norway

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.

Conditions

• Breast Cancer

Interventions

OTHER

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).

OTHER

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.

Sponsors & Collaborators

• Helse Vest

  collaborator OTHER

• Helse Midt-Norge

  collaborator OTHER

• Helse Nord

  collaborator INDUSTRY

• Norwegian Cancer Society

  collaborator OTHER

• Norwegian Institute of Public Health

  lead OTHER_GOV

Principal Investigators

• Solveig Hofvind, PhD · Norwegian Institute of Public Health

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

69 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-11-25

Primary Completion

2026-11-30

Completion

2033-06-30

Countries

• Norway

Study Locations