AI-enhanced LF-MRI in Epilepsy (ALF-ME)

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.