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The Use of AI to Safely Reduce the Workload in Breast Cancer Screening With Mammography in Region Östergötland

NCT06187350 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60000

Last updated 2025-06-06

No results posted yet for this study

Summary

The overall aim of the project is to investigate how artificial intelligence (AI) can be used to streamline and at the same time increase diagnostic safety in breast cancer screening with mammography. AI has been shown in a number of studies to have great potential for both increasing diagnostic certainty (e.g. reduced occurrence of interval cancers) and at the same time reducing the workload for doctors. However, much research remains to clinically validate these new tools and to increase the understanding of how they affect the work of doctors. The specific goal of the project is to investigate whether the implementation of AI in breast cancer screening in Östergötland, Sweden, can increase the sensitivity (the mammography examination's ability to find breast cancer) and the specificity (that is, the right case is selected for further investigation: a minimum of healthy women are recalled but so many breast cancer cases that are possible are selected for further investigation) and at the same time make screening more efficient through reduced workload. AI will be implemented in the clinical routine and performance metrics such as cancer detection rate etc will be closely monitored. The study do not assign specific interventions to the study participants.

Conditions

  • Artificial Intelligence
  • Breast Diseases
  • Neoplasms
  • Breast Neoplasms

Interventions

DEVICE

AI cancer detection system

The AI system Transpara (Screenpoint Medical, The Netherlands) will be implemented for triaging two-image mammography examinations based on the probability of malignancy. Transpara assigns a score from 1 to 10 to each examination, indicating the risk of malignancy. A score between 1 and 7 indicates a low risk of cancer, 8-9 indicates an intermediate and 10 an elevated risk of cancer. Examinations with an AI score between 1 and 7 will be reviewed by only one radiologist, while examinations with an AI score \> 7 will be double-reviewed as normal.

Sponsors & Collaborators

  • Ostergotland County Council, Sweden

    lead OTHER

Principal Investigators

  • Håkan Gustafsson, Ph.D. · Region Östergötland

Eligibility

Min Age
40 Years
Max Age
74 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2025-03-20
Completion
2025-03-20
FDA Device
Yes

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06187350 on ClinicalTrials.gov