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Triage Radiology Imaging Assessment for Greater Effectiveness (TRIAGE)

25 juni 2026 bijgewerkt door: King's College London

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

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).

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

100800

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Intervention - MIDI ON
Scans are triaged by the MIDI AI tool. The system automatically classifies each MRI scan as either "normal" or "abnormal" shortly after image acquisition.
Apparaat: MIDI
MIDI is an AI-based TRIAGE tool and its primary purpose is workflow triage of brain MRI scans.
Geen tussenkomst: Control - MIDI OFF
MRI scans are reported according to standard care in chronological order, with no AI prioritisation.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Turnaround time for abnormal outpatient brain MRI scans
Tijdsspanne: Time from abnormal MRI acquisition to radiologist report authorisation over 8 months.
Time from abnormal MRI acquisition to radiologist report authorisation over 8 months.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Turnaround time for abnormal inpatient brain MRI scans
Tijdsspanne: Time from abnormal MRI acquisition to radiologist report authorisation over 8 months.
Time from abnormal MRI acquisition to radiologist report authorisation over 8 months.
Turnaround time for abnormal combined Brain MRI scans
Tijdsspanne: Time from abnormal MRI acquisition to radiologist report authorisation over 8 months.
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
Tijdsspanne: From MRI scan acquisition to final radiologist report authorisation over 8 months.
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
Tijdsspanne: From MRI scan acquisition to initiation of treatment over 8 months.
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
Tijdsspanne: 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.
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.
Staff satisfaction - Questionnaire score from radiologists, radiographers, and referring clinicians, collected at month 6 of the intervention
Tijdsspanne: From the start to month 6 of the intervention.
From the start to month 6 of the intervention.
Turnaround time for all brain MRI scans (normal and abnormal combined)
Tijdsspanne: Time from MRI acquisition to final radiologist report acquisition over 8 months
Time from MRI acquisition to final radiologist report acquisition over 8 months
Turnaround Time for Critically Abnormal Brain MRI scans
Tijdsspanne: Acquisition of critically abnormal brain MRI scans to final radiologist report authorisation over 8 months.
Acquisition of critically abnormal brain MRI scans to final radiologist report authorisation over 8 months.
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
Tijdsspanne: MRI scan acquisition to final radiologist report authorisation over 8 months.
MRI scan acquisition to final radiologist report authorisation over 8 months.
Clinical Effectiveness Outcomes in patients with Suspected Transient Ischemic Attack/Stroke (time from MRI acquisition to definitive diagnosis, censoring or treatment change)
Tijdsspanne: Time from MRI Acquisition to Definitive Diagnosis or Censoring, Time from MRI Acquisition to Treatment Change during Phase I and II (19 months)
Time from MRI Acquisition to Definitive Diagnosis or Censoring, Time from MRI Acquisition to Treatment Change during Phase I and II (19 months)
Proportion of diagnoses within 14 days in a subgroup of patients diagnosed with melanoma or lung cancer with de novo metastases
Tijdsspanne: Within 14 days following index brain scan containing brain metastases
Within 14 days following index brain scan containing brain metastases
Mortality rates in a subgroup of patients diagnosed with melanoma or lung cancer with de novo metastases
Tijdsspanne: Within 28 days following the index MRI brain scan and within 90 days following the index MRI brain scan
Within 28 days following the index MRI brain scan and within 90 days following the index MRI brain scan
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
Tijdsspanne: Days alive and out of hospitals within 90 days following index MRI brain scan
Days alive and out of hospitals within 90 days following index MRI brain scan
Time to Treatment Change in a subgroup of patients diagnosed with melanoma or lung cancer with de novo metastases
Tijdsspanne: Time from MRI scan acquisition to treatment (or censoring at the end of the data collection period) within 8 months.
Time from MRI scan acquisition to treatment (or censoring at the end of the data collection period) within 8 months.
Occurrence of treatment/SRS (Stereotactic Radiosurgery) treatment in a subgroup of patients diagnosed with melanoma or lung cancer with de novo metastases
Tijdsspanne: Treatment - Within 48 days following index MRI brain scan Treatment with SRS - Within 90 days following index brain MRI scan
Treatment - Within 48 days following index MRI brain scan Treatment with SRS - Within 90 days following index brain MRI scan
Functional status using ECOG and KPS where possible in a subgroup of patients diagnosed with melanoma or lung cancer with de novo metastases
Tijdsspanne: 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
Within 90 days following index MRI brain scan
Brain tumour-related Quality of Life in a consenting sub-group of patients with eligible brain metastases measured using EORTC QLQ-C30 questionnaire
Tijdsspanne: At 90 days (± 14 days) following the index MRI brain scan
At 90 days (± 14 days) following the index MRI brain scan
Functional status in a consenting sub-group of patients with eligible brain metastases using ECOG and KPS scoring
Tijdsspanne: 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
At 90 days (± 14 days) following index MRI brain scan
Brain tumour-related Quality of Life in a consenting sub-group of patients with eligible brain metastases measured using EORTC QLQ-BN20 questionnaire
Tijdsspanne: At 90 days (± 14 days) following the index MRI brain scan
At 90 days (± 14 days) following the index MRI brain scan

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

King's College London

Medewerkers

The Leeds Teaching Hospitals NHS Trust
Queen Mary University of London

Onderzoekers

  • Studie stoel: Thomas C Booth, King's College London

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 maart 2027

Primaire voltooiing (Geschat)

1 maart 2030

Studie voltooiing (Geschat)

1 maart 2030

Studieregistratiedata

Eerst ingediend

18 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

25 juni 2026

Eerst geplaatst (Werkelijk)

26 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

25 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 350683

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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