Deployment of an AI solution for supporting breast cancer diagnosis
Research type
Research Study
Full title
DEployment of an AI-based solution for supporting Breast cancer diagnosis and assessment of Overall cost-effectiveness, Reliability, Accuracy and impact on Healthcare (DEBORAH)
IRAS ID
341229
Contact name
Manuela Vecsler
Contact email
Sponsor organisation
Ibex Medical Analytics LTD
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 6 months, 29 days
Research summary
This study is a funded Phase 4 AI in Health and Care Award that aims to demonstrate the clinical and economic impact of the Galen Breast in the NHS to inform procurement decisions and facilitate systems adoption.
The objective of the study is to evaluate whether pathologists supported by the Galen Breast workflow achieve shorter turnaround time, as well as to evaluate the efficiency of the AI-supported workflow in terms of pathologists’ review time and diagnostic accuracy, when compared to the baseline (standard of care). Although this AI solution has shown very high performance when assessing biopsy cores in other healthcare settings, it is important to assess its utility, interoperability/integration within NHS settings and generalizability on a UK-based population as differences in processing tissue, pathology reporting and workflows might impact on the tool’s utility.
Galen™ Breast is CE marked and registered with the UK MHRA, and it is routinely used in NHS trusts, multiple EU countries, and worldwide.
REC name
London - Bromley Research Ethics Committee
REC reference
24/LO/0312
Date of REC Opinion
25 Apr 2024
REC opinion
Further Information Favourable Opinion