Artificial Intelligence in Mammography Screening in Norway

NCT06032390 | Recruiting DMC

• 1 other identifier: 366405
• Study Type: interventional
• Target: 150,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer Screening; Digital Mammography; Artificial Intelligence; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Screen-detected breast cancers

  Number of breast cancers detected at screening per 1000 screening examinations.

  36 months from study start-up

Secondary Outcomes (9)

• Consensus rate

  24 months from study start-up

• Recall rate

  24 months from study start-up

• Interval breast cancers

  60 months from study start-up

• Prognostic and predictive tumor characteristics of screen-detected breast cancer

  36 months from study start-up

• Prognostic and predictive tumor characteristics of interval breast cancer

  60 months from study start-up

Study Arms (2)

Intervention arm

EXPERIMENTAL

AI assisted mammography screening interpretation

Other: AI assisted mammography screening interpretation

Control arm

ACTIVE COMPARATOR

Standard mammography screening interpretation (standard procedure)

Other: Standard mammography screening interpretation

Interventions

AI assisted mammography screening interpretation OTHER

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).

Intervention arm

Standard mammography screening interpretation OTHER

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.

Control arm

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women attending the population-based mammography screening program BreastScreen Norway providing a signed, informed consent

You may not qualify if:

• Women attending the population-based mammography screening program BreastScreen Norway not providing a signed, informed consent

Sponsors & Collaborators

• Norwegian Institute of Public Health: lead
• Helse Vest: collaborator
• Helse Midt-Norge: collaborator
• Helse Nord: collaborator
• Norwegian Cancer Society: collaborator

Study Sites (1)

Cancer Registry of Norway, Norwegian Institute of Public Health

Oslo, Norway

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Solveig Hofvind, PhD

  Norwegian Institute of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Solveig Hofvind, PhD

CONTACT

22928828; sshh@kreftregisteret.no

Åsne S Holen, MSc

CONTACT

asho@kreftregisteret.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Neither the participant nor the radiologic technician performing the mammography examination will know to what study arm the participant was allocated. Radiologists reading the screening examinations will be blinded to the intervention at initial reading but not in the consensus meeting.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to an intervention or control arm. Intervention arm will be triaged based on AI result score.

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: September 13, 2023
• Study Start: November 25, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): June 1, 2033
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)