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NCT Number: NCT07671664

Triage Radiology Imaging Assessment for Greater Effectiveness

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).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

NHS radiology services are under unprecedented pressure as rising demand outpaces available workforce capacity. MRI utilisation across the NHS has increased by 9% year-on-year. As a result, many departments have relied on unsustainable measures such as outsourcing and weekend insourcing to manage reporting backlogs.

Delays in scan reporting have serious implications, including missed or delayed diagnoses, prolonged hospital stays, higher healthcare costs, and poorer patient outcomes. A systematic review and meta-analysis found that each month of delay in initiating cancer treatment increases mortality risk by approximately 10%.

There is an urgent need for validated digital tools that can reduce TATs without compromising diagnostic accuracy. The TRIAGE study (Triage Radiology Imaging Assessment for Greater Effectiveness (TRIAGE): a Cluster-Randomised Crossover Trial Evaluating the Reporting Turn-Around-Time of Brain Magnetic Resonance Images using an AI-enabled Abnormality Detector for Prioritisation) evaluates whether MIDI can reduce the average TAT of abnormal scans in routine NHS clinical practice.

The primary purpose of MIDI is workflow triage: it enables prioritisation of abnormal scans within radiology reporting worklists, helping departments manage high volumes efficiently.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).
  • Brain MRI scan series will automatically be included if they contain the required scan sequences and are of the required resolution.
  • Patient with stage III/IV malignant melanoma undergoing regular surveillance MRI brain scans presenting with de novo brain metastases.
  • Patient with lung cancer undergoing pre-radical treatment staging MRI brain scans presenting with de novo brain metastases.
  • Patients with de novo symptomatic brain metastases secondary to melanoma and/or lung cancer and/or breast cancer detected on MRI brain scans from all patient pathways.

Additionally for those completing EORTC questionnaires:

● Able to give consent and likely to be able to complete EORTC questionnaires.

Exclusion criteria

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.
  • 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 stage III/IV malignant melanoma, or not undergoing regular surveillance MRI brain scans, or not presenting with de novo brain metastases.
  • Patient without lung cancer undergoing pre-radical treatment staging MRI brain scans, or not presenting with de novo brain metastases.
  • Patients without de novo symptomatic brain metastases secondary to melanoma and/or lung cancer and/or breast cancer detected on MRI brain scans.

Additionally for those completing EORTC questionnaires:

● Unable to give consent and unlikely to be able to complete EORTC questionnaires.

Treatment and study plan

MIDI

Device

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

Primary outcomes

  1. Turnaround time for abnormal outpatient brain MRI scans

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

Secondary outcomes

  1. Turnaround time for abnormal inpatient brain MRI scans

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

  2. Turnaround time for abnormal combined Brain MRI scans

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

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

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

  4. 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

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

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

    Time frame: 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.

    Incremental cost per change in turnaround time, time to diagnosis, time to treatment change, in 28-day mortality, in 90-day mortality, in ECOG/KPS at 90 days.

  6. Staff satisfaction - Questionnaire score from radiologists, radiographers, and referring clinicians, collected at month 6 of the intervention

    Time frame: From the start to month 6 of the intervention.

  7. Turnaround time for all brain MRI scans (normal and abnormal combined)

    Time frame: Time from MRI acquisition to final radiologist report acquisition over 8 months

  8. Turnaround Time for Critically Abnormal Brain MRI scans

    Time frame: Acquisition of critically abnormal brain MRI scans to final radiologist report authorisation over 8 months.

  9. Performance accuracy - MIDI assessment of abnormal/normal brain MRI scan, radiologist assessment of abnormal/normal brain MRI scan and reference standard of abnormal/normal brain MRI scan

    Time frame: MRI scan acquisition to final radiologist report authorisation over 8 months.

  10. Clinical Effectiveness Outcomes in patients with Suspected Transient Ischemic Attack/Stroke (time from MRI acquisition to definitive diagnosis, censoring or treatment change)

    Time frame: Time from MRI Acquisition to Definitive Diagnosis or Censoring, Time from MRI Acquisition to Treatment Change during Phase I and II (19 months)

  11. Proportion of diagnoses within 14 days in a subgroup of patients diagnosed with melanoma or lung cancer with de novo metastases

    Time frame: Within 14 days following index brain scan containing brain metastases

  12. Mortality rates in a subgroup of patients diagnosed with melanoma or lung cancer with de novo metastases

    Time frame: Within 28 days following the index MRI brain scan and within 90 days following the index MRI brain scan

  13. Days alive and out of hospital following index MRI brain scan in a subgroup of patients diagnosed with melanoma or lung cancer with de novo metastases

    Time frame: Days alive and out of hospitals within 90 days following index MRI brain scan

  14. Time to Treatment Change in a subgroup of patients diagnosed with melanoma or lung cancer with de novo metastases

    Time frame: Time from MRI scan acquisition to treatment (or censoring at the end of the data collection period) within 8 months.

  15. Occurrence of treatment/SRS (Stereotactic Radiosurgery) treatment in a subgroup of patients diagnosed with melanoma or lung cancer with de novo metastases

    Time frame: Treatment - Within 48 days following index MRI brain scan Treatment with SRS - Within 90 days following index brain MRI scan

  16. Functional status using ECOG and KPS where possible in a subgroup of patients diagnosed with melanoma or lung cancer with de novo metastases

    Time frame: Within 90 days following index MRI brain scan

    ECOG: Standardised 0 to 4 scale - 0 is fully active, 4 is completely disabled KPS - 10 to 100 scale - 10 is critically ill, 100 is no evidence of disease

  17. Brain tumour-related Quality of Life in a consenting sub-group of patients with eligible brain metastases measured using EORTC QLQ-C30 questionnaire

    Time frame: At 90 days (± 14 days) following the index MRI brain scan

  18. Functional status in a consenting sub-group of patients with eligible brain metastases using ECOG and KPS scoring

    Time frame: At 90 days (± 14 days) following index MRI brain scan

    ECOG: Standardised 0 to 4 scale - 0 is fully active, 4 is completely disabled KPS - 10 to 100 scale - 10 is critically ill, 100 is no evidence of disease

  19. Brain tumour-related Quality of Life in a consenting sub-group of patients with eligible brain metastases measured using EORTC QLQ-BN20 questionnaire

    Time frame: At 90 days (± 14 days) following the index MRI brain scan

Study contacts

Contact information is provided by the study sponsor or research team.

Giusi Manfredi, PhD

CONTACT

[email protected]

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PCTU Trial Management team

CONTACT

[email protected]

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Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • Queen Mary University of London
  • The Leeds Teaching Hospitals NHS Trust

Registry information

Official study title

Triage Radiology Imaging Assessment for Greater Effectiveness (TRIAGE): a Cluster-Randomised Crossover Trial Evaluating the Reporting Turn-Around-Time of Brain Magnetic Resonance Images Using an AI-enabled Abnormality Detector for Prioritisation

Acronym: TRIAGE

Important dates

Study start
2027
Primary completion
2030
Study completion
2030
First posted
Jun 26, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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