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Completed

NCT Number: NCT05048095

Artificial Intelligence in Breast Cancer Screening in Region Östergötland Linkoping

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).

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Key information

Conditions

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

Age range

40 year–74 year

Sex eligibility

Female

Study type

Observational

Primary location

Region Östergötland

Linköping, Östergötland County, 58185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AI cancer detection system

Other

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

Primary outcomes

  1. Cancer Detection rate

    Time frame: After 4 months of inclusion

    Proportion of women diagnosed with breast cancer among those recalled after consensus

  2. Recall or referral rate

    Time frame: After 4 months of inclusion

    Proportion of women who are referred for further diagnostic workup after consensus

  3. Positive predictive value of referrals

    Time frame: After 4 months of inclusion

    Proportion of women diagnosed with breast cancer among those referred

Secondary outcomes

  1. Positive predictive value of Transpara® scores

    Time frame: After 4 months of inclusion

    Proportion of breast cancers diagnosed among women with a given AI score

Sponsors and collaborators

Lead sponsor

Ostergotland County Council, Sweden

Other

Registry information

Official study title

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

Acronym: AI-ROL

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 17, 2021
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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