MedPath

MIDI (MR Imaging Abnormality Deep Learning Identification)

Recruiting
Conditions
Neurological Disorder
Registration Number
NCT04368481
Lead Sponsor
King's College Hospital NHS Trust
Brief Summary

The study involves the development and testing of an artificial intelligence (AI) tool that can identify abnormalities using patient head scans conducted for routine clinical care and research volunteer scans. A deep learning algorithm will be developed using a dataset of retrospective and prospective MRI head scans to train, validate, and test convolutional networks using software developed at the Department of Biomedical Engineering, King's College London. The reference standard will be consultant radiologist reports of the MRI head scans.

Detailed Description

An automated strategy for identifying abnormalities in head scans could address the unmet clinical need for faster abnormality identification times, potentially allowing for early intervention to improve short- and long-term clinical outcomes. Radiologist shortages and increased demand for MRI scans lead to delays in reporting, particularly in the outpatient setting.

Furthermore, there is a wide variation in the management of incidental findings (IFs) discovered in 'healthy volunteers.' The routine reporting of 'healthy volunteer' scans by a radiologist poses logistical and financial challenges. It would be valuable to devise automated strategies to reliably and accurately identify IFs, potentially reducing the number of scans requiring routine radiological review by up to 90%, thus increasing the feasibility of implementing a routine reporting strategy.

Deep learning is a novel technique in computer science that automatically learns hierarchies of relevant features directly from the raw inputs (such as MRI or CT) using multi-layered neural networks. A deep learning algorithm will be trained on a large database of head MRI scans to recognize scans with abnormalities. This algorithm will be trained to classify a subset of these scans as normal or abnormal and then tested on an independent subset to determine its validity.

If the tested neural network demonstrates high diagnostic accuracy, future research participants and patients may benefit, as not all institutions currently review their research scans for incidental findings and clinical scans may not be reported for weeks in some cases. In both research and clinical scenarios, an algorithm could rapidly identify abnormal pathology and prioritize scans for reporting.

In summary, the aim is to develop a deep learning abnormality detection algorithm for use in both research and clinical settings.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
30000
Inclusion Criteria
  • All head MRI scans with compatible sequences
  • > 18 years old
Exclusion Criteria
  • No corresponding radiologist report
  • No consent for future use of the research images held within the historic database stored at The Centre for Neuroimaging Sciences (Kings College London).
  • Poor image quality

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Sensitivity and specificity of a convolutional neural network to recognise abnormalities on head MRI scans.At end of study (5-year study)

Sensitivity, specificity, positive predictive value, and negative predictive values.

Secondary Outcome Measures
NameTimeMethod
Sensitivity and specificity of a convolutional neural network to broadly categorise abnormalities on head MRI scans.At end of study (5-year study)

Sensitivity, specificity, positive predictive value, and negative predictive values.

Trial Locations

Locations (32)

South Eastern Health & Social Care Trust

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Dundonald, United Kingdom

The Queen Elizabeth Hospital King'S Lynn Nhs Trust

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King's Lynn, United Kingdom

Princess Royal University Hospital, King's College Hospital NHS Foundation Trust

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Orpington, Kent, United Kingdom

Buckinghamshire Healthcare Nhs Trust (Stoke Mandeville)

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Aylesbury, United Kingdom

Mid and South Essex NHS Foundation Trust

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Basildon, United Kingdom

Forth Valley Royal Hospital

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Larbert, United Kingdom

Leeds Teaching Hospital NHS Trust

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Leeds, United Kingdom

Medway Nhs Foundation Trust

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Gillingham, United Kingdom

Bedfordshire Hospitals Nhs Foundation Trust

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Bedford, United Kingdom

Northern Lincolnshire and Goole Nhs Foundation Trust

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Scunthorpe, United Kingdom

East Kent Hospitals University Nhs Foundation Trust

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Canterbury, United Kingdom

Queen Victoria Hospital Nhs Foundation Trust

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East Grinstead, United Kingdom

Kingston Hospital Nhs Foundation Trust

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Kingston, United Kingdom

Kings' College Hospital

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London, United Kingdom

Calderdale and Huddersfield NHS Foundation Trust

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Huddersfield, United Kingdom

NHS FIFE

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Kirkcaldy, United Kingdom

CNS, Maudsley Hospital, South London and Maudsley NHS Foundation Trust

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London, United Kingdom

Croydon University Hospital, Croydon Health Services NHS Trust

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London, United Kingdom

Norfolk and Norwich University Hospitals Nhs Foundation Trust

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Norwich, United Kingdom

Guy's Hospital, Guy's and St Thomas's NHS Foundation Trust

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London, United Kingdom

St George'S University Hospitals Nhs Foundation Trust

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Tooting, United Kingdom

Queen's Medical Centre University Hospital, Nottingham University Hospitals NHS Foundation Trust

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Nottingham, United Kingdom

St George's Hospital, St George's University Hospital NHS Foundation Trust

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London, United Kingdom

Betsi Cadwaladr University Health Board

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Bodelwyddan, United Kingdom

University Hospitals of Leicester Nhs Trust

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Leicester, United Kingdom

St Thomas' Hospital, Guy's and St Thomas's NHS Foundation Trust

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London, United Kingdom

Mid and South Essex Nhs Foundation Trust

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Southend, United Kingdom

Surrey and Sussex Healthcare Nhs Trust

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Redhill, United Kingdom

East Sussex Healthcare Nhs Trust

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Saint Leonards-on-Sea, United Kingdom

Torbay and South Devon Nhs Foundation Trust

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Torquay, United Kingdom

West Hertfordshire Hospitals Nhs Trust

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Watford, United Kingdom

Royal Cornwall Hospitals Nhs Trust

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Truro, United Kingdom

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