BrainTRIAGENCT07671664
Triage Radiology Imaging Assessment for Greater Effectiveness
A study testing MIDI in people with Brain, run by King's College London.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain
- What is being tested?
- MIDI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100,800 participants
- Where
- No sites listed yet
- Study dates
- Mar 2027to Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 21Show fewer
- 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.
Who cannot join
- 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
Show all 23Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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).
Read the detailed description
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.
- Conditions
- Brain
- Being tested
- MIDI
- Keywords
- TRIAGE, MIDI, AI Brain MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIDIDevice
MIDI is an AI-based TRIAGE tool and its primary purpose is workflow triage of brain MRI scans.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MIDI |
| Control - MIDI OFF | No intervention | MRI scans are reported according to standard care in chronological order, with no AI prioritisation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Turnaround time for abnormal outpatient brain MRI scans
Measured: Time from abnormal MRI acquisition to radiologist report authorisation over 8 months.
Secondary outcomes (19)
Turnaround time for abnormal inpatient brain MRI scans
Measured: Time from abnormal MRI acquisition to radiologist report authorisation over 8 months.
Turnaround time for abnormal combined Brain MRI scans
Measured: 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
Measured: 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
Measured: 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
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.
Measured: 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
Measured: From the start to month 6 of the intervention.
Turnaround time for all brain MRI scans (normal and abnormal combined)
Measured: Time from MRI acquisition to final radiologist report acquisition over 8 months
Turnaround Time for Critically Abnormal Brain MRI scans
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
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
Measured: 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
Measured: 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
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
Measured: 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
Measured: At 90 days (± 14 days) following the index MRI brain scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study startMar 2027 (estimated)
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for BrainStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary University of London, The Leeds Teaching Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Thomas C Booth, Study chair, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671664
- Sponsor's protocol ID
- 350683
- Acronym
- TRIAGE
- Status last verified
- Jun 2026
- First submitted
- 18 May 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25519890van 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.
PubMed 23017638Hooper 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.
PubMed 27350420Powers 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.
ClinicalTrials.gov. Study NCT04368481. https://clinicaltrials.gov/study/NCT04368481https://www.sciencedirect.com/science/article/pii/S1361841522000433
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.
PubMed 35183876NHS England (2023). Faster Diagnosis Standard. https://www.england.nhs.uk/cancer/faster-diagnosis
NICE (2022). Evidence Standards Framework for Digital Health Technologies. https://www.nice.org.uk/corporate/ecd7
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
Royal College of Radiologists (2023). Clinical Radiology Workforce Census Report. https://www.rcr.ac.uk
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.
PubMed 33148535
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07671664
- Acronym / sponsor ID
- TRIAGE / 350683
- Conditions
- Brain
- Keywords
- TRIAGE, MIDI, AI Brain MRI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100,800 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Queen Mary University of London, The Leeds Teaching Hospitals NHS Trust
- Study start
- Mar 2027 (estimated)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention - MIDI ON | Experimental | Device: MIDIScans are triaged by the MIDI AI tool. The system automatically classifies each MRI scan as either "normal" or "abnormal" shortly after image acquisition. |
| Control - MIDI OFF | No intervention | –MRI scans are reported according to standard care in chronological order, with no AI prioritisation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIDIMIDI is an AI-based TRIAGE tool and its primary purpose is workflow triage of brain MRI scans. | Device | Intervention - MIDI ON |
Primary outcome
Turnaround time for abnormal outpatient brain MRI scans
Time frame: Time from abnormal MRI acquisition to radiologist report authorisation over 8 months.
19 secondary outcomes
Turnaround time for abnormal inpatient brain MRI scans
Time frame: Time from abnormal MRI acquisition to radiologist report authorisation over 8 months.
Turnaround time for abnormal combined Brain MRI scans
Time frame: 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
Time frame: 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
Time frame: 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
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.
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.
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
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.
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.
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)
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
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
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
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.
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Background: PubMed 25519890Candel 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.
- Background: PubMed 23017638van 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.
- Background: PubMed 27350420Hooper 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.
- BackgroundPowers 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.
- BackgroundClinicalTrials.gov. Study NCT04368481. https://clinicaltrials.gov/study/NCT04368481https://www.sciencedirect.com/science/article/pii/S1361841522000433
- Background: PubMed 35183876Wood 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.
- BackgroundNHS England (2023). Faster Diagnosis Standard. https://www.england.nhs.uk/cancer/faster-diagnosis
- BackgroundNICE (2022). Evidence Standards Framework for Digital Health Technologies. https://www.nice.org.uk/corporate/ecd7
- BackgroundRothwell 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
- BackgroundRoyal College of Radiologists (2023). Clinical Radiology Workforce Census Report. https://www.rcr.ac.uk
- Background: PubMed 33148535Hanna 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.
- Individual participant dataSharing planned: No
Related trials for Brain
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Recruiting
Dietary Intervention for Migraine Relief
Migraine
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas C Booth study chair
King's College London
Questions about this trial
What is this clinical trial studying?
A study testing MIDI in people with Brain, run by King's College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PCTU Trial Management team (00, pctu-triage@qmul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Turnaround time for abnormal outpatient brain MRI scans (time frame: Time from abnormal MRI acquisition to radiologist report authorisation over 8 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07671664, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.