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Artificial Intelligence in Breast Cancer Screening in Region Östergötland Linkoping

The Use of AI as a Third Reader and During Consensus in a Double Reading Breast Cancer Screening Program in Sweden

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05048095
Acronym
AI-ROL
Enrollment
15500
Registered
2021-09-17
Start date
2021-10-15
Completion date
2022-02-15
Last updated
2022-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Artificial intelligence

Brief summary

The purpose of this observational study is to assess whether the use of AI (Transpara®) can lead to an improved quality of a double reading mammography screening program. This is investigated by performing AI as a third reader and as a decision support during the consensus meeting, compared with conventional mammography screening (double reading and consensus without AI).

Detailed description

The AI cancer detection system will act as a 3rd reader and will recall additional cases to the consensus conference: the exams that were not recalled by double reading but are classified as the 3% most suspicious exams, based on AI derived cancer-risk scores. Secondly, AI is used as a decision support during consensus. AI risk scores and Computer-Aided Detection (CAD)-marks of suspicious calcifications and soft tissue lesions are provided to the reader(s). The hypothesis of this study is that the use of AI has the potential to improve the quality of the screening program by increasing the cancer detection rate without affecting the recall rate.

Interventions

The use of AI as a third reader and as a decision support system during consensus meeting

Sponsors

Ostergotland County Council, Sweden
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 74 Years
Healthy volunteers
No

Inclusion criteria

* Women participating in the regular Breast Cancer Screening Program in Region Östergötland Linkoping

Exclusion criteria

* Women with breast implants or other foreign implants in the mammogram * Women with symptoms or signs of suspected breast cancer

Design outcomes

Primary

MeasureTime frameDescription
Cancer Detection rateAfter 4 months of inclusionProportion of women diagnosed with breast cancer among those recalled after consensus
Recall or referral rateAfter 4 months of inclusionProportion of women who are referred for further diagnostic workup after consensus
Positive predictive value of referralsAfter 4 months of inclusionProportion of women diagnosed with breast cancer among those referred

Secondary

MeasureTime frameDescription
Positive predictive value of Transpara® scoresAfter 4 months of inclusionProportion of breast cancers diagnosed among women with a given AI score

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026