Artificial Intelligence in Large-scale Breast Cancer Screening (ScreenTrustCAD)
Primary Purpose
Breast Neoplasm Female
Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
AI CAD
Radiologist reading
Sponsored by

About this trial
This is an interventional diagnostic trial for Breast Neoplasm Female focused on measuring Artificial Intelligence, Breast Cancer, Mammography, Screening
Eligibility Criteria
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
Sites / Locations
- Capio St Göran Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard of Care
AI CAD combination
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Incident breast cancer
Breast cancer diagnosis by pathologist
Incident breast cancer
Breast cancer diagnosis by pathologist
Incident breast cancer
Breast cancer diagnosis by pathologist
Secondary Outcome Measures
Reader flagging
Radiologist or AICAD assessing the mammograms as suspicious or not suspicious for malignancy
Consensus recall
A decision by the consensus discussion to recall the woman for further work-up
Tissue sampling
Biopsy or fine needle aspiration performed
Process failure
Failure of the AI CAD software to generate AI scores
Full Information
NCT ID
NCT04778670
First Posted
February 22, 2021
Last Updated
March 10, 2023
Sponsor
Karolinska University Hospital
Collaborators
Capio Sankt Görans Hospital, Lunit Inc., Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT04778670
Brief Title
Artificial Intelligence in Large-scale Breast Cancer Screening
Acronym
ScreenTrustCAD
Official Title
Artificial Intelligence in a Population-based Breast Cancer Screening - the Prospective Clinical Trial ScreenTrust CAD
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
June 9, 2022 (Actual)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Capio Sankt Görans Hospital, Lunit Inc., Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm Female
Keywords
Artificial Intelligence, Breast Cancer, Mammography, Screening
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
ParticipantCare ProviderInvestigator
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.
Allocation
Non-Randomized
Enrollment
55579 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
AI CAD combination
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
AI CAD
Other Intervention Name(s)
Lunit INSIGHT MMG
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Radiologist reading
Intervention Description
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)
Primary Outcome Measure Information:
Title
Incident breast cancer
Description
Breast cancer diagnosis by pathologist
Time Frame
At Screening
Title
Incident breast cancer
Description
Breast cancer diagnosis by pathologist
Time Frame
Within 12 months after screening
Title
Incident breast cancer
Description
Breast cancer diagnosis by pathologist
Time Frame
Within 23 months after screening
Secondary Outcome Measure Information:
Title
Reader flagging
Description
Radiologist or AICAD assessing the mammograms as suspicious or not suspicious for malignancy
Time Frame
At screening
Title
Consensus recall
Description
A decision by the consensus discussion to recall the woman for further work-up
Time Frame
At screening
Title
Tissue sampling
Description
Biopsy or fine needle aspiration performed
Time Frame
At screening
Title
Process failure
Description
Failure of the AI CAD software to generate AI scores
Time Frame
At screening
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fredrik Strand, MD PhD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Capio St Göran Hospital
City
Stockholm
ZIP/Postal Code
11219
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Artificial Intelligence in Large-scale Breast Cancer Screening
We'll reach out to this number within 24 hrs