Artificial Intelligence in Mammography Screening in Norway

Not Applicable

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06032390
• Lead Sponsor: Norwegian Institute of Public Health

Brief 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.

Detailed Description

Independent double reading with consensus is the recommended practice for breast cancer screening programs in Europe. This is a time-consuming process and more than 99% of examinations are determined to have a negative final outcome in BreastScreen Norway. However, radiologist still overlook cancers, and review-studies have shown 20-25% of screen-detected and interval cancers to be visible at prior screening mammograms. In Norway and other countries, there is also a shortage of breast radiologists.

Retrospective studies on AI in mammographic screening have shown promising results in the classification of cancer negative and cancer positive examinations. However, prospective studies are needed to elucidate questions concerning AI as a support or replacement for the radiologists in the interpretation process.

In this randomized controlled trial women attending screening and consenting to participate in the study, will be randomized (1:1 allocation) to an intervention or a control group. The screening examination will be performed as usual in both groups. The intervention in the trial is the interpretation procedure.

All examinations will be analyzed by AI. In the intervention group, examinations will be triaged according to risk of malignancy defined by an AI score. Examinations with a low AI score (1-7) will have a single reading by one radiologist and examinations with a intermediate or high AI score (8-10) will have an independent double reading by two radiologists. All examinations selected by either one or both radiologist will be discussed at consensus. Examinations with an AI raw score of \>9.8 will be discussed at consensus independent of the radiologists' interpretation. The radiologists will be blinded to whether the mammograms are interpreted by one or two radiologists. AI risk scores and AI image marking of suspicious calcifications and masses are only provided to the radiologists at consensus, not during independent reading. In the control group, two independent radiologists will interpret all screening examinations according to standard procedure, independent double reading. AI results will not be available at either independent reading or consensus, only for comparison with the intervention group in final analyses.

Screen-detected cancers in the intervention and control arm will be analyzed in terms of non-inferiority.

Study Timeline

• Study First Submitted: 2023-07-05
• Study First Submitted QC: 2023-09-04
• Study First Posted: 2023-09-13
• Study Start: 2024-11-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2026-11
• Study Completion: 2033-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Screen-detected breast cancers	36 months from study start-up	Number of breast cancers detected at screening per 1000 screening examinations.

Secondary Outcome Measures

Name	Time	Method
Interval breast cancers	60 months from study start-up	Number of interval breast cancers diagnosed per 1000 screening examinations.
Prognostic and predictive tumor characteristics of screen-detected breast cancer	36 months from study start-up	Distribution of tumor characteristics among the participants with screen-detected breast cancer.
Prognostic and predictive tumor characteristics of interval breast cancer	60 months from study start-up	Distribution of tumor characteristics among the participants with interval breast cancer.
Sensitivity	60 months from study start-up	Proportion of true positives among true positive and false negatives (%).
Consensus rate	24 months from study start-up	Proportion of participant discussed in consensus among all participants (%).
Recall rate	24 months from study start-up	Proportion of women recalled for further assessment among all participants (%).
Specificity	60 months from study start-up	Proportion of true negatives among true negatives and false positives (%).
Mammographic features of screen-detected breast cancer	36 months from study start-up	Distribution of characteristics of tumors observed on the mammograms of participants diagnosed with screen-detected breast cancer.
Time spent screen-reading	36 months from study start-up	Time (minutes:seconds) spent by the individual radiologists interpreting screening mammograms

Trial Locations

Locations (1)

Cancer Registry of Norway, Norwegian Institute of Public Health; 🇳🇴 Oslo, Norway