Breast Cancer Clinical Trial
— AIMS NorwayOfficial title:
Artificial Intelligence in BreastScreen Norway - a Randomized Controlled Trial
NCT number | NCT06032390 |
Other study ID # | 366405 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2024 |
Est. completion date | June 2033 |
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.
Status | Not yet recruiting |
Enrollment | 150000 |
Est. completion date | June 2033 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 50 Years to 69 Years |
Eligibility | 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, or with breast implants |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Cancer Registry of Norway | Helse Midt-Norge, Helse Nord, Helse Vest, Norwegian Cancer Society |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Screen-detected breast cancers | Number of breast cancers detected at screening per 1000 screening examinations. | 36 months from study start-up | |
Secondary | Consensus rate | Proportion of participant discussed in consensus among all participants (%). | 24 months from study start-up | |
Secondary | Recall rate | Proportion of women recalled for further assessment among all participants (%). | 24 months from study start-up | |
Secondary | Interval breast cancers | Number of interval breast cancers diagnosed per 1000 screening examinations. | 60 months from study start-up | |
Secondary | Prognostic and predictive tumor characteristics of screen-detected breast cancer | Distribution of tumor characteristics among the participants with screen-detected breast cancer. | 36 months from study start-up | |
Secondary | Prognostic and predictive tumor characteristics of interval breast cancer | Distribution of tumor characteristics among the participants with interval breast cancer. | 60 months from study start-up | |
Secondary | Sensitivity | Proportion of true positives among true positive and false negatives (%). | 60 months from study start-up | |
Secondary | Specificity | Proportion of true negatives among true negatives and false positives (%). | 60 months from study start-up | |
Secondary | Mammographic features of screen-detected breast cancer | Distribution of characteristics of tumors observed on the mammograms of participants diagnosed with screen-detected breast cancer. | 36 months from study start-up | |
Secondary | Time spent screen-reading | Time (minutes:seconds) spent by the individual radiologists interpreting screening mammograms | 36 months from study start-up |
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