NCT04368481

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
1 country

33 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

5.4 years

First QC Date

February 18, 2020

Last Update Submit

April 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity of a convolutional neural network to recognise abnormalities on head MRI scans.

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

    At end of study (5-year study)

Secondary Outcomes (1)

  • Sensitivity and specificity of a convolutional neural network to broadly categorise abnormalities on head MRI scans.

    At end of study (5-year study)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult MRI head scan patients presenting at secondary and tertiary NHS centres across the UK for any indication.

You may qualify if:

  • All head MRI scans with compatible sequences
  • \> 18 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

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

Orpington, Kent, United Kingdom

RECRUITING

Buckinghamshire Healthcare Nhs Trust (Stoke Mandeville)

Aylesbury, United Kingdom

RECRUITING

Mid and South Essex NHS Foundation Trust

Basildon, United Kingdom

RECRUITING

Bedfordshire Hospitals Nhs Foundation Trust

Bedford, United Kingdom

RECRUITING

Betsi Cadwaladr University Health Board

Bodelwyddan, United Kingdom

RECRUITING

East Kent Hospitals University Nhs Foundation Trust

Canterbury, United Kingdom

RECRUITING

South Eastern Health & Social Care Trust

Dundonald, BT16 1RH, United Kingdom

RECRUITING

Queen Victoria Hospital Nhs Foundation Trust

East Grinstead, United Kingdom

RECRUITING

Medway Nhs Foundation Trust

Gillingham, United Kingdom

RECRUITING

Northern Lincolnshire and Goole Nhs Foundation Trust

Grimsby, United Kingdom

RECRUITING

Calderdale and Huddersfield NHS Foundation Trust

Huddersfield, United Kingdom

RECRUITING

The Queen Elizabeth Hospital King'S Lynn Nhs Trust

Kings Lynn, United Kingdom

RECRUITING

Kingston Hospital Nhs Foundation Trust

Kingston, United Kingdom

RECRUITING

NHS FIFE

Kirkcaldy, KY2 5AH, United Kingdom

RECRUITING

Forth Valley Royal Hospital

Larbert, FK5 4WR, United Kingdom

RECRUITING

Leeds Teaching Hospital NHS Trust

Leeds, United Kingdom

RECRUITING

University Hospitals of Leicester Nhs Trust

Leicester, United Kingdom

RECRUITING

Kings' College Hospital

London, SE5 9RS, United Kingdom

COMPLETED

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

London, United Kingdom

RECRUITING

Croydon University Hospital, Croydon Health Services NHS Trust

London, United Kingdom

RECRUITING

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

London, United Kingdom

RECRUITING

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

London, United Kingdom

RECRUITING

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

London, United Kingdom

RECRUITING

Norfolk and Norwich University Hospitals Nhs Foundation Trust

Norwich, United Kingdom

RECRUITING

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

Nottingham, United Kingdom

RECRUITING

Surrey and Sussex Healthcare Nhs Trust

Redhill, United Kingdom

RECRUITING

East Sussex Healthcare Nhs Trust

Saint Leonards-on-Sea, United Kingdom

RECRUITING

Northern Lincolnshire and Goole Nhs Foundation Trust

Scunthorpe, United Kingdom

RECRUITING

Mid and South Essex Nhs Foundation Trust

Southend, United Kingdom

RECRUITING

St George'S University Hospitals Nhs Foundation Trust

Tooting, United Kingdom

RECRUITING

Torbay and South Devon Nhs Foundation Trust

Torquay, United Kingdom

COMPLETED

Royal Cornwall Hospitals Nhs Trust

Truro, United Kingdom

RECRUITING

West Hertfordshire Hospitals Nhs Trust

Watford, United Kingdom

RECRUITING

Related Publications (1)

  • Wood DA, Guilhem E, Kafiabadi S, Al Busaidi A, Dissanayake K, Hammam A, Mansoor N, Townend M, Agarwal S, Wei Y, Mazumder A, Barker GJ, Sasieni P, Ourselin S, Cole JH, Nair N, Geetha A, Onyekwuluje C, Dineen R, Dhillon P, Costigan C, Fatania K, Igra M, Nichols R, Saada J, Juette A, Barbara RR, Spohr H, Booth TC; MIDI Consortium Group. Self-Supervised Text-Vision Alignment for Automated Brain MRI Abnormality Detection: A Multicenter Study (ALIGN Study). Radiol Artif Intell. 2026 Mar;8(2):e240619. doi: 10.1148/ryai.240619.

MeSH Terms

Conditions

Nervous System Diseases

Study Officials

  • Thomas Booth

    King's College Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2020

First Posted

April 29, 2020

Study Start

April 1, 2019

Primary Completion

August 31, 2024

Study Completion

March 31, 2025

Last Updated

April 10, 2024

Record last verified: 2024-04

Locations