Artificial Intelligence in Mammography Screening in Norway (AIMS Norway)

January 12, 2026 updated by: Norwegian Institute of Public Health

Artificial Intelligence in BreastScreen Norway - a Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

150000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Norway
      • Oslo, Norway
        • Recruiting
        • Cancer Registry of Norway, Norwegian Institute of Public Health
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm
AI assisted mammography screening interpretation
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).
Active Comparator: Control arm
Standard mammography screening interpretation (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Screen-detected breast cancers
Time Frame: 36 months from study start-up
Number of breast cancers detected at screening per 1000 screening examinations.
36 months from study start-up

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian Institute of Public Health

Collaborators

Helse Vest
Norwegian Cancer Society
Helse Midt-Norge
Helse Nord

Investigators

  • Principal Investigator: Solveig Hofvind, PhD, Norwegian Institute of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

June 1, 2033

Study Registration Dates

First Submitted

July 5, 2023

First Submitted That Met QC Criteria

September 4, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Estimated)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 366405

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will not be shared outside the project group.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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