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Triage Radiology Imaging Assessment for Greater Effectiveness (TRIAGE)

25 giugno 2026 aggiornato da: 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).

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

100800

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Diagnostico
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: MIDI
MIDI is an AI-based TRIAGE tool and its primary purpose is workflow triage of brain MRI scans.
Nessun intervento: Control - MIDI OFF
MRI scans are reported according to standard care in chronological order, with no AI prioritisation.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Turnaround time for abnormal outpatient brain MRI scans
Lasso di tempo: Time from abnormal MRI acquisition to radiologist report authorisation over 8 months.
Time from abnormal MRI acquisition to radiologist report authorisation over 8 months.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Turnaround time for abnormal inpatient brain MRI scans
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: At 90 days (± 14 days) following the index MRI brain scan
At 90 days (± 14 days) following the index MRI brain scan

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

King's College London

Collaboratori

The Leeds Teaching Hospitals NHS Trust
Queen Mary University of London

Investigatori

  • Cattedra di studio: Thomas C Booth, King's College London

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 marzo 2027

Completamento primario (Stimato)

1 marzo 2030

Completamento dello studio (Stimato)

1 marzo 2030

Date di iscrizione allo studio

Primo inviato

18 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

25 giugno 2026

Primo Inserito (Effettivo)

26 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 350683

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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