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AI-enhanced LF-MRI in Epilepsy

Evaluation of Artificial Intelligence-enhanced Low Field

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07717632
Acronym
ALF-ME
Enrollment
39
Registered
2026-07-21
Start date
2025-09-18
Completion date
2026-08-31
Last updated
2026-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

Low-field MRI, Low- and middle-income countries, Epilepsy, Neuroimaging, Resource-limited

Brief summary

The global burden of epilepsy is high affecting over 50 million people worldwide. Majority live in low- and middleincome countries (LMICs) where access to diagnosis and treatment is limited. Accurate diagnosis of epilepsy and identification of the underlying cause through brain imaging is key to providing appropriate treatment. Magnetic resonance imaging (MRI) is the recommended modality of choice for brain imaging. However, in many LMICs it is scarce, and the cost of maintenance is unattainable. This study aims to explore the usefulness of a lower cost, more portable MRI machine for epilepsy diagnosis. It will be a proof-of-concept study evaluating the utility of low magnetic field MRI (LF-MRI) in epilepsy diagnosis. It will include 30 adults with epilepsy who have undergone a high field MRI (HF-MRI) brain scan as part of their routine clinical care under the University College London (UCL) Hospitals (UCLH), within twelve months of recruitment. Participants will be consecutively recruited and offered a LF-MRI brain scan on the Swoop MR Imaging System (Hyperfine) at the Birbeck-UCL Centre for Neuroimaging (BUCNI). Image post-processing will be performed using the open access machine learning program, LF-SynthSR, to enhance the image quality and allow for quantitative image analysis. Anonymised HF- and LF-MRI scans will be independently reported using a structured reporting template by two neuroradiologists. A perception survey will be administered to all participants to assess their tolerability of the LF-MRI. This study will serve as a foundation for future studies in this field and in areas where such innovations are most needed.

Detailed description

The aim of this study is to determine the utility of AI-enhanced Low Field (AI-LF) MRI in the identification of focal brain lesions in adults with epilepsy. This is a proof-of-concept study evaluating the utility of AI-LF-MRI in aiding identification of potentially epileptogenic brain lesions, by comparing neuroradiologists' lesion detection on this modality versus standard HF-MRI. It will include \ 30 adults with epilepsy who have undergone a high field (1.5T or 3T) MRI (HF-MRI) brain scan as part of their routine clinical care at University College London (UCL) Hospitals (UCLH), within the previous twelve months. Participants will be consecutively recruited and offered a LF-MRI brain scan on the 0.064T Swoop MR Imaging System (Hyperfine®) at the Birkbeck-UCL Centre for Neuroimaging (BUCNI). Image post-processing will be performed using the open access machine learning program, LF-SynthSR, to enhance the image quality and allow for quantitative image analysis. Anonymised HF- and LF-MRI scans will be independently reported using a structured reporting template by two neuroradiologists. A perception survey will be administered to all participants to assess their tolerability of the LF-MRI. Each participant will only have a single encounter with the study on the day they get their LF-MRI scan. There is no follow-up required with this study. Inclusion criteria: 1. Adults aged between \>18 years and \<70 years 2. Diagnosis of epilepsy and attending a UCLH-affiliated outpatient epilepsy clinic 3. Undergone a 1.5T or 3T MRI Brain scan within 12 months of recruitment as part of standard clinical care. 4. Can tolerate MRI scanning without sedation. Exclusion criteria 1\. Cognitive impairment that precludes ability to consent or assent to the study 2. Inability to lie flat for the duration of the scan 3. Body habitus incompatible with LF-MRI device 4. Presence of MRI contraindications as stipulated by standard MRI operating procedures We will recruit at least 30 patients, of these, 20 patients will have a visible lesion on the HF-MRI scan (reference standard). A sample size of 20 patients will be sufficient to demonstrate that the proportion of lesions similarly identified is at least 0.8, against a null hypothesis of 0.5, using a one-sample, one-sided exact binomial test with a 5% significance level and a power of 80%. The rest will not have a visible potentially epileptogenic lesion on the HF-MRI scan. Two consultant neuroradiologists will separately and independently report AI-LF- then HF-MRI scans according to set criteria, including, MRI scanner field strength, presence of lesion, lesion location and artefacts. They will be provided with basic participant clinical details such as age, seizure type and. EEG findings, but blinded to diagnosis. Rates of lesion detection and false positives in the AI-LF-MRI scans will be compared with the reference standard of a recent clinical HF-MRI and reported as proportions. Sensitivity and specificity analyses will be performed for the qualitative analysis of AI-LF-MRI. Intraclass coefficients and Bland Altman analyses will be used to compare quantitative inter-rater and inter-method agreement, respectively. Descriptive statistics such as medians (IQR) and proportions will be used to describe participants' demographic information and survey responses.

Interventions

DIAGNOSTIC_TESTMRI

Low magnetic field MRI of the brain

Sponsors

University College, London
Lead SponsorOTHER
University College London Hospitals
CollaboratorOTHER
The Leverhulme Trust
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Single group. All participants will undergo a scan on the device being investigated for diagnostic accuracy.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

1. Adults aged between \>17 years and \<70 years 2. Diagnosis of epilepsy and attending at UCLH-affiliated outpatient epilepsy clinic 3. Undergone a 1.5T or 3T MRI Brain scan within 12 months of recruitment as part of standard clinical care 4. Can tolerate MRI scanning without sedation.

Exclusion criteria

1. Cognitive impairment that precludes ability to consent or assent to the study 2. Inability to lie flat 3. Body habitus incompatible with LF-MRI device 4. Presence of MRI contraindications as stipulated by standard MRI operating procedures

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity of AI-LF-MRI for lesion detection, measured as the proportion of lesions identified on HF-MRI that are also detected on AI-LF-MRI by blinded neuroradiologist review.Baseline assessment (within the study imaging visit). Participant will only undergo a low-field MRI scan which will be compared to a reference high-field MRI scan done within 12 months of enrolment.The rate of correctly identified abnormalities on the AI-enhanced low-field MRI when compared to standard of care high-field MRI. There is no pre-specified "good" rate assigned for this pilot study.

Secondary

MeasureTime frameDescription
Proportion of scans with clinically significant artefacts, determined by blinded neuroradiologist assessment, on AI-LF-MRI compared with HF-MRIBaseline assessment (within the study imaging visit)Rate of reported artefacts, including movement, blurring and signal inhomogeneity, on AI-LF-MRI compared to HF-MRI
Inter-rater agreement among blinded neuroradiologists for qualitative lesion detection and classification on AI-LF-MRI and HF-MRI, measured using Cohen's kappa for pairwise agreement between raters and Fleiss' kappa for agreement across all ratersBaseline assessment (within the study imaging visit)Compare agreement of lesions identified among radiologists reading the scans
Inter-method agreement between AI-LF-MRI and HF-MRI for quantitative imaging measures, assessed using Bland-Altman analysis.Baseline assessment (within the study imaging visit)Comparative analysis of hippocampal volume segmentation of the SuperSynth (AI tool) of low-field vs high-field MRI
Acceptability of the LF-MRI scanning process, assessed using participant responses to a custom acceptability questionnaireBaseline assessment (within the study imaging visit)Participants answer a custom-made questionnaire immediately after their low-field MRI scan on the Hyperfine. The questionnaire has closed-ended questions about their experience, with a few opportunities for open comment.

Countries

United Kingdom

Contacts

PRINCIPAL_INVESTIGATORJohn S Duncan, DM

University College, London

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 24, 2026