Artificial Intelligence in Breast Cancer Screening in Region Östergötland Linkoping (AI-ROL)

April 19, 2022 updated by: Håkan Gustafsson, Ostergotland County Council, Sweden

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

15500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Östergötland
      • Linköping, Östergötland, Sweden, 58185
        • Region Östergötland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women eligible for population-based mammography screening

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Screened women in Region Östergötland Linkoping
Other: AI cancer detection system
The use of AI as a third reader and as a decision support system during consensus meeting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer Detection rate
Time Frame: After 4 months of inclusion
Proportion of women diagnosed with breast cancer among those recalled after consensus
After 4 months of inclusion
Recall or referral rate
Time Frame: After 4 months of inclusion
Proportion of women who are referred for further diagnostic workup after consensus
After 4 months of inclusion
Positive predictive value of referrals
Time Frame: After 4 months of inclusion
Proportion of women diagnosed with breast cancer among those referred
After 4 months of inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
After 4 months of inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ostergotland County Council, Sweden

Investigators

  • Principal Investigator: Håkan Gustafsson, PhD, Linköping University - University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2021

Primary Completion (Actual)

February 15, 2022

Study Completion (Actual)

February 15, 2022

Study Registration Dates

First Submitted

September 8, 2021

First Submitted That Met QC Criteria

September 8, 2021

First Posted (Actual)

September 17, 2021

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT20210157-AI-ROL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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