Clinical trial NCT06032390: Artificial Intelligence in Mammography Screening in Norway
Official title: Artificial Intelligence in BreastScreen Norway - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer Screening
Digital Mammography
Artificial Intelligence
Randomized Controlled Trial
Lead sponsor: Norwegian Institute of Public Health
Sponsor class: OTHER_GOV
Collaborators: name: Helse Vest
name: Helse Midt-Norge
name: Helse Nord
name: Norwegian Cancer Society
First posted: 2023-09-13
Enrollment: 150000
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to an intervention or control arm. Intervention arm will be triaged based on AI result score.
Primary purpose: SCREENING

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.

Eligibility criteria: 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 outcomes:
measure: Screen-detected breast cancers
timeFrame: 36 months from study start-up
Secondary outcomes:
measure: Consensus rate
timeFrame: 24 months from study start-up
measure: Recall rate
timeFrame: 24 months from study start-up
measure: Interval breast cancers
timeFrame: 60 months from study start-up
measure: Prognostic and predictive tumor characteristics of screen-detected breast cancer
timeFrame: 36 months from study start-up
measure: Prognostic and predictive tumor characteristics of interval breast cancer
timeFrame: 60 months from study start-up
measure: Sensitivity
timeFrame: 60 months from study start-up
measure: Specificity
timeFrame: 60 months from study start-up
measure: Mammographic features of screen-detected breast cancer
timeFrame: 36 months from study start-up
measure: Time spent screen-reading
timeFrame: 36 months from study start-up
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Cancer Registry of Norway, Norwegian Institute of Public Health
Study officials:
affiliation: Norwegian Institute of Public Health
name: Solveig Hofvind, PhD
role: PRINCIPAL_INVESTIGATOR
References: