Artificial Intelligence in Large-scale Breast Cancer Screening (ScreenTrustCAD)

March 10, 2023 updated by: Fredrik Strand, Karolinska University Hospital

Artificial Intelligence in a Population-based Breast Cancer Screening - the Prospective Clinical Trial ScreenTrust CAD

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55579

Phase

  • Not Applicable

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
      • Stockholm, Sweden, 11219
        • Capio St Göran Hospital

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

Description

Inclusion Criteria:

  • Participants in regular population-based breast cancer screening at Capio St Göran Hospital

Exclusion Criteria:

  • Incomplete exam (complete exam: mediolateral oblique and craniocaudal images of Left and Right breast)
  • Breast implant
  • Complete mastectomy (excluded from screening positive group)
  • Participant in surveillance program for prior 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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care
Standard of Care means all examinations will receive a flagging decision by: first reader and second reader radiologist as usual. However, in this paired design all participants will belong to both arms.
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)
Experimental: AI CAD combination
AI CAD combination in the primary end-point means the combination of the flagging decision of the first reader and AI CAD; in the secondary end-points it means any combination of AI alone, or AI in combination with first, second and both readers.
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)
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.
Other Names:
  • Lunit INSIGHT MMG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incident breast cancer
Time Frame: At Screening
Breast cancer diagnosis by pathologist
At Screening
Incident breast cancer
Time Frame: Within 12 months after screening
Breast cancer diagnosis by pathologist
Within 12 months after screening
Incident breast cancer
Time Frame: Within 23 months after screening
Breast cancer diagnosis by pathologist
Within 23 months after screening

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reader flagging
Time Frame: At screening
Radiologist or AICAD assessing the mammograms as suspicious or not suspicious for malignancy
At screening
Consensus recall
Time Frame: At screening
A decision by the consensus discussion to recall the woman for further work-up
At screening
Tissue sampling
Time Frame: At screening
Biopsy or fine needle aspiration performed
At screening
Process failure
Time Frame: At screening
Failure of the AI CAD software to generate AI scores
At screening

Collaborators and Investigators

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

Sponsor

Karolinska University Hospital

Collaborators

Karolinska Institutet
Lunit Inc.
Capio Sankt Görans Hospital

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)

April 1, 2021

Primary Completion (Actual)

June 9, 2022

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

February 22, 2021

First Submitted That Met QC Criteria

February 26, 2021

First Posted (Actual)

March 3, 2021

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 10, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STGKS001
  • EPM 2020-00487 (Other Identifier: Ethical Review Authority (Sweden))
  • K 2020-0807 (Other Identifier: Karolinska University Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

To the extent allowed by source institution, legal agreements, and applicable laws and regulations

IPD Sharing Time Frame

At study start

IPD Sharing Access Criteria

Anyone can access study protocol and SAP.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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