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Triage Radiology Imaging Assessment for Greater Effectiveness (TRIAGE)

25. června 2026 aktualizováno: 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).

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

100800

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Diagnostický
  • Přidělení: Randomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Přístroj: MIDI
MIDI is an AI-based TRIAGE tool and its primary purpose is workflow triage of brain MRI scans.
Žádný zásah: Control - MIDI OFF
MRI scans are reported according to standard care in chronological order, with no AI prioritisation.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Časové okno
Turnaround time for abnormal outpatient brain MRI scans
Časové okno: Time from abnormal MRI acquisition to radiologist report authorisation over 8 months.
Time from abnormal MRI acquisition to radiologist report authorisation over 8 months.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Turnaround time for abnormal inpatient brain MRI scans
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: At 90 days (± 14 days) following the index MRI brain scan
At 90 days (± 14 days) following the index MRI brain scan

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

King's College London

Spolupracovníci

The Leeds Teaching Hospitals NHS Trust
Queen Mary University of London

Vyšetřovatelé

  • Studijní židle: Thomas C Booth, King's College London

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. března 2027

Primární dokončení (Odhadovaný)

1. března 2030

Dokončení studie (Odhadovaný)

1. března 2030

Termíny zápisu do studia

První předloženo

18. května 2026

První předloženo, které splnilo kritéria kontroly kvality

25. června 2026

První zveřejněno (Aktuální)

26. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

26. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

25. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

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