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Artificial Intelligence in Large-scale Breast Cancer Screening

NCT04778670 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55579

Last updated 2023-03-14

No results posted yet for this study

Summary

This is a prospective clinical trial following a paired screen-positive design, with the aims to assess the performance of an artificial intelligence (AI) computer-aided detection (CAD) algorithm as an independent reader, in addition to two radiologists, of screening mammograms in a true screening population. Since all decisions by individual readers will be recorded, it is possible to determine what the outcome would have been had one or two of the readers not been allowed to assess images, and to determine what the outcome would have been had the recall decision been performed by consensus decision (actual) compared to single reader arbitration of discordant cases.

Conditions

  • Breast Neoplasm Female

Interventions

DIAGNOSTIC_TEST

AI CAD

The Lunit INSIGHT MMG will be used as the AI CAD in our study. Initially, version 1.6.1.1 will be installed. The software version will be continuously updated with subsequent software releases, after confirming in a historic calibration dataset that the performance is improved. The operating point will be set based on a historic calibration dataset to attain a joint sensitivity of breast cancer detection of AI and first reader which is 2% higher than for first and second reader.

DIAGNOSTIC_TEST

Radiologist reading

Standard of care, each radiologist will assess the mammography examination, making a binary flagging decision (flag the examination to continue to consensus discussion, or not)

Sponsors & Collaborators

  • Capio Sankt Görans Hospital

    collaborator OTHER

  • Lunit Inc.

    collaborator INDUSTRY

  • Karolinska Institutet

    collaborator OTHER

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • Fredrik Strand, MD PhD · Karolinska University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2022-06-09
Completion
2024-12-31

Countries

  • Sweden

Study Locations

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Entities

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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 NCT04778670 on ClinicalTrials.gov