Clinical trial NCT04778670: Artificial Intelligence in Large-scale Breast Cancer Screening
Official title: Artificial Intelligence in a Population-based Breast Cancer Screening - the Prospective Clinical Trial ScreenTrust CAD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Neoplasm Female
Keywords: Artificial Intelligence
Breast Cancer
Mammography
Screening
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Capio Sankt Görans Hospital
name: Lunit Inc.
name: Karolinska Institutet
First posted: 2021-03-03
Enrollment: 55579
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Incident breast cancer
timeFrame: At Screening
measure: Incident breast cancer
timeFrame: Within 12 months after screening
measure: Incident breast cancer
timeFrame: Within 23 months after screening
Secondary outcomes:
measure: Reader flagging
timeFrame: At screening
measure: Consensus recall
timeFrame: At screening
measure: Tissue sampling
timeFrame: At screening
measure: Process failure
timeFrame: At screening
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Capio St Göran Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Fredrik Strand, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: