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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04778670
Recruitment Status : Active, not recruiting
First Posted : March 3, 2021
Last Update Posted : August 22, 2022
Sponsor:
Collaborators:
Capio Sankt Görans Hospital
Lunit Inc.
Karolinska Institutet
Information provided by (Responsible Party):
Fredrik Strand, Karolinska University Hospital

Tracking Information
First Submitted Date  ICMJE February 22, 2021
First Posted Date  ICMJE March 3, 2021
Last Update Posted Date August 22, 2022
Actual Study Start Date  ICMJE April 1, 2021
Actual Primary Completion Date June 9, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2021)
  • Incident breast cancer [ Time Frame: At Screening ]
    Breast cancer diagnosis by pathologist
  • Incident breast cancer [ Time Frame: Within 12 months after screening ]
    Breast cancer diagnosis by pathologist
  • Incident breast cancer [ Time Frame: Within 23 months after screening ]
    Breast cancer diagnosis by pathologist
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2021)
  • Reader flagging [ Time Frame: At screening ]
    Radiologist or AICAD assessing the mammograms as suspicious or not suspicious for malignancy
  • Consensus recall [ Time Frame: At screening ]
    A decision by the consensus discussion to recall the woman for further work-up
  • Tissue sampling [ Time Frame: At screening ]
    Biopsy or fine needle aspiration performed
  • Process failure [ Time Frame: At screening ]
    Failure of the AI CAD software to generate AI scores
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Artificial Intelligence in Large-scale Breast Cancer Screening
Official Title  ICMJE Artificial Intelligence in a Population-based Breast Cancer Screening - the Prospective Clinical Trial ScreenTrust CAD
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
This is a prospective clinical trial following a paired screen-positive design (Pepe, Alonzo; 2001), with the aims to assess the performance of an AI algorithm combined with radiologists(s) compared to standard-of-care being two radiologists assessing 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.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Positive disease status is ascertained by pathology-verified breast cancer. Disease status is not known to any of the actors (except for the outcomes assessor by necessity). AI decision is not known by the care provider radiologists until they have made their decisions. In the subsequent consensus discussion where a decision is made to recall or not to recall a woman, the AI decision is known. After AI decision has been recorded and outcomes have been assessed, the investigators will have full information on outcomes and AI decisions.
Primary Purpose: Diagnostic
Condition  ICMJE Breast Neoplasm Female
Intervention  ICMJE
  • 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 Name: Lunit INSIGHT MMG
  • 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)
Study Arms  ICMJE
  • 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.
    Intervention: Diagnostic Test: Radiologist reading
  • 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.
    Interventions:
    • Diagnostic Test: AI CAD
    • Diagnostic Test: Radiologist reading
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 18, 2022)
55579
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2021)
55000
Estimated Study Completion Date  ICMJE December 2024
Actual Primary Completion Date June 9, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04778670
Other Study ID Numbers  ICMJE STGKS001
EPM 2020-00487 ( Other Identifier: Ethical Review Authority (Sweden) )
K 2020-0807 ( Other Identifier: Karolinska University Hospital )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: To the extent allowed by source institution, legal agreements, and applicable laws and regulations
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: At study start
Access Criteria: Anyone can access study protocol and SAP.
Current Responsible Party Fredrik Strand, Karolinska University Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Karolinska University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Capio Sankt Görans Hospital
  • Lunit Inc.
  • Karolinska Institutet
Investigators  ICMJE
Principal Investigator: Fredrik Strand, MD PhD Karolinska University Hospital
PRS Account Karolinska University Hospital
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP