KMT018 PEGASUS: Prospective RCT for AI in Double Reading Workflow
Research type
Research Study
Full title
A prospective randomised controlled trial (RCT) to assess the impact and benefits of using an AI system in live double reading practice for breast cancer screening
IRAS ID
339966
Contact name
Alice Leaver
Contact email
Sponsor organisation
Kheiron Medical Technologies Ltd
Duration of Study in the UK
1 years, 0 months, days
Research summary
This prospective study is a randomised controlled trial (RCT) designed to evaluate the impact of live use of the medical device ‘Mia’, a software using artificial intelligence technology to interpret mammograms.
The primary study objective and endpoint will evaluate the primary double reading workflow with Mia in the first phase of the study to confirm the safety and efficacy of using Mia in live double reading in real-world settings. The primary Mia workflow is where Mia triages negative cases to save the workload of a second human reader. This means if the first human reader and Mia agree not to recall the case, it will only be reviewed by one human rather than two human radiologists. This workflow is also known as double reader triage (DRT). Additionally, Mia is used as an extra reader where Mia flags suspicious cases for additional review after an initial no recall decision is made in the DRT portion of the workflow.
A secondary Mia workflow will also be evaluated to provide additional evidence of this variation in a second phase. These two Mia workflow variations have been previously rigorously evaluated to be safe and to provide optimal benefits to breast screening.
In the study, eligible participants are randomised into one of two arms, Arm A and Arm B. Those randomised into Arm B will receive standard of care breast screening, with their mammograms being ‘double read’ by at least two human radiologists. Participants in Arm A will have their case read by at least one human radiologist and by a second human reader or by Mia, based on the implemented Mia workflow variation.
REC name
South East Scotland REC 02
REC reference
24/SS/0027
Date of REC Opinion
3 May 2024
REC opinion
Further Information Favourable Opinion