Triage Radiology Imaging Assessment for Greater Effectiveness

NCT07671664 | Not Yet Recruiting DMC

• 1 other identifier: 350683
• Study Type: interventional
• Target: 100,800
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the trial is to understand whether a computerised tool designed to quickly spot problems in brain scans (MIDI) can help doctors diagnose cases faster. This will help patients by getting them the treatment they need sooner. How useful doctors find the tool will also be measured, and whether it is cost-saving for the National Health Service (NHS).

Conditions

Brain

Keywords

TRIAGE; MIDI; AI Brain MRI

Outcome Measures

Primary Outcomes (1)

• Turnaround time for abnormal outpatient brain MRI scans

  Time from abnormal MRI acquisition to radiologist report authorisation over 8 months.

Secondary Outcomes (19)

• Turnaround time for abnormal inpatient brain MRI scans

  Time from abnormal MRI acquisition to radiologist report authorisation over 8 months.

• Turnaround time for abnormal combined Brain MRI scans

  Time from abnormal MRI acquisition to radiologist report authorisation over 8 months.

• Cost Effectiveness - Incremental cost per reduction in brain MRI scan turnaround time, radiologist reporting time, insourcing/outsourcing of reporting activity

  From MRI scan acquisition to final radiologist report authorisation over 8 months.

• Cost Effectiveness for patients with suspected TIA or Stroke - incremental cost per reduction in brain MRI turnaround time, time to diagnosis and time to treatment change

  From MRI scan acquisition to initiation of treatment over 8 months.

• Cost Effectiveness for patients newly diagnosed with brain metastases secondary to melanoma, lung cancer, or breast cancer

  From MRI scan acquisition to initiation of treatment within 8 months as well as from MRI scan acquisition to 28 and 90 days for mortality and 90 days for ECOG/KPS outcomes.

Study Arms (2)

Intervention - MIDI ON

EXPERIMENTAL

Scans are triaged by the MIDI AI tool. The system automatically classifies each MRI scan as either "normal" or "abnormal" shortly after image acquisition.

Device: MIDI

Control - MIDI OFF

NO INTERVENTION

MRI scans are reported according to standard care in chronological order, with no AI prioritisation.

Interventions

MIDI DEVICE

MIDI is an AI-based TRIAGE tool and its primary purpose is workflow triage of brain MRI scans.

Intervention - MIDI ON

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For main trial
• Adult patient (≥ 18 years of age) at the time of MRI.
• Brain MRI scan performed at a participating NHS site during the defined study period (intervention or control arm).
• Brain MRI scan series will automatically be included if they contain the required scan sequences and are of the required resolution.
• For O3 subgroup ● Radiologists, radiographers, and referring clinicians involved with the use of the MIDI tool at sites who consent to completing the staff survey
• For O7 subgroup
• Adult patient (≥ 18 years of age) at the time of MRI.
• Brain MRI scan performed at a participating NHS site during the defined study period (intervention or control arm).
• Brain MRI scan series will automatically be included if they contain the required scan sequences and are of the required resolution.
• Patient with suspected de novo stroke/TIA in TIA/Stroke pathway.
• Patient with suspected de novo stroke/TIA in Acute Neurology pathway.
• Patient with suspected de novo stroke/TIA identified via SSNAP review.
• For O8 subgroup
• Adult patient (≥ 18 years of age) at the time of MRI.
• Brain MRI scan performed at a participating NHS site during the defined study period (intervention or control arm).

You may not qualify if:

• For main trial
• Patient is under 18 years of age at the time of MRI.
• Brain MRI scan not performed at a participating NHS site or outside the defined study period.
• Data will be excluded for those patients who have opted out of the use of their data for research under the National Data Opt-Out.
• Brain MRI scan series will automatically be excluded if they do not contain the required scan sequences and/or the required resolution.
• For O3 subgroup ● Radiologists, radiographers, and referring clinicians involved with the use of the MIDI tool at sites who do not consent to completing the staff survey
• For O7 subgroup
• Patient is under 18 years of age at the time of MRI.
• Brain MRI scan not performed at a participating NHS site or outside the defined study period.
• Data will be excluded for those patients who have opted out of the use of their data for research under the National Data Opt-Out.
• Brain MRI scan series will automatically be excluded if they do not contain the required scan sequences and/or the required resolution.
• Patient without suspected de novo stroke/TIA or not on TIA/Stroke pathway.
• Patient without suspected de novo stroke/TIA or not on Acute Neurology pathway.
• For O8 subgroup
• Patient is under 18 years of age at the time of MRI.

Sponsors & Collaborators

• King's College London: lead
• Queen Mary University of London: collaborator
• The Leeds Teaching Hospitals NHS Trust: collaborator

Related Publications (11)

• Candel MJ, van Breukelen GJ. Sample size calculation for treatment effects in randomized trials with fixed cluster sizes and heterogeneous intraclass correlations and variances. Stat Methods Med Res. 2015 Oct;24(5):557-73. doi: 10.1177/0962280214563100. Epub 2014 Dec 17.

  PMID: 25519890 BACKGROUND

• van Breukelen GJ, Candel MJ. Calculating sample sizes for cluster randomized trials: we can keep it simple and efficient! J Clin Epidemiol. 2012 Nov;65(11):1212-8. doi: 10.1016/j.jclinepi.2012.06.002.

  PMID: 23017638 BACKGROUND

• Hooper R, Teerenstra S, de Hoop E, Eldridge S. Sample size calculation for stepped wedge and other longitudinal cluster randomised trials. Stat Med. 2016 Nov 20;35(26):4718-4728. doi: 10.1002/sim.7028. Epub 2016 Jun 28.

  PMID: 27350420 BACKGROUND

• Powers DMW (2011). "Evaluation: From Precision, Recall and F-Measure to ROC, Informedness, Markedness & Correlation". Journal of Machine Learning Technologies. 2 (1): 37-63. doi:10.1186/s12880-015-0068-x.

  BACKGROUND

• ClinicalTrials.gov. Study NCT04368481. https://clinicaltrials.gov/study/NCT04368481https://www.sciencedirect.com/science/article/pii/S1361841522000433

  BACKGROUND

• Wood DA, Kafiabadi S, Busaidi AA, Guilhem E, Montvila A, Lynch J, Townend M, Agarwal S, Mazumder A, Barker GJ, Ourselin S, Cole JH, Booth TC. Deep learning models for triaging hospital head MRI examinations. Med Image Anal. 2022 May;78:102391. doi: 10.1016/j.media.2022.102391. Epub 2022 Feb 12.

  PMID: 35183876 BACKGROUND

• NHS England (2023). Faster Diagnosis Standard. https://www.england.nhs.uk/cancer/faster-diagnosis

  BACKGROUND

• NICE (2022). Evidence Standards Framework for Digital Health Technologies. https://www.nice.org.uk/corporate/ecd7

  BACKGROUND

• Rothwell PM et al. (2007). Early risk of stroke after a transient ischaemic attack. JAMA, 297(14), 1472-1482. https://jamanetwork.com/journals/jama/fullarticle/193353

  BACKGROUND

• Royal College of Radiologists (2023). Clinical Radiology Workforce Census Report. https://www.rcr.ac.uk

  BACKGROUND

• Hanna TP, King WD, Thibodeau S, Jalink M, Paulin GA, Harvey-Jones E, O'Sullivan DE, Booth CM, Sullivan R, Aggarwal A. Mortality due to cancer treatment delay: systematic review and meta-analysis. BMJ. 2020 Nov 4;371:m4087. doi: 10.1136/bmj.m4087.

  PMID: 33148535 BACKGROUND

Study Officials

• Thomas C Booth

  King's College London

  STUDY CHAIR

Central Study Contacts

PCTU Trial Management team

CONTACT

00; pctu-triage@qmul.ac.uk

Giusi Manfredi, PhD

CONTACT

00; giusi.manfredi@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The TRIAGE study is a definitive, cluster-randomised crossover trial (CRT). Each participating site will be involved for a total duration of 22 months, and the study has four stages: * Run In Period * Phase I of Intervention * Wash-Out Period * Phase II of Intervention At randomisation, sites are allocated (in a 1:1 ratio) to two sequences of intervention conditions. There are two possible intervention conditions: * Intervention- MIDI ON: Scans are triaged by the MIDI AI tool. Abnormal scans are flagged and moved to the front of the radiologist's worklist in real-time; * Control-MIDI OFF: MRI scans are reported according to standard care in chronological order, with no AI prioritisation. The two possible sequences to which a site may be randomised are: MIDI on in the first phase, crossing over to MIDI OFF in the second phase; or MIDI OFF in the first phase, crossing over to MIDI ON in the second phase.

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: June 26, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share