Evaluation of Artificial Intelligence-enhanced Low Field
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Proportion of similarly detected lesions on AI-LF-MRI compared to HF-MRI.
研究概览
简要总结
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.
详细描述
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:
- Adults aged between >18 years and <70 years
- Diagnosis of epilepsy and attending a UCLH-affiliated outpatient epilepsy clinic
- Undergone a 1.5T or 3T MRI Brain scan within 12 months of recruitment as part of standard clinical care.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged between >17 years and <70 years
- •Diagnosis of epilepsy and attending at UCLH-affiliated outpatient epilepsy clinic
- •Undergone a 1.5T or 3T MRI Brain scan within 12 months of recruitment as part of standard clinical care
- •Can tolerate MRI scanning without sedation.
排除标准
- •Cognitive impairment that precludes ability to consent or assent to the study
- •Inability to lie flat
- •Body habitus incompatible with LF-MRI device
- •Presence of MRI contraindications as stipulated by standard MRI operating procedures
研究组 & 干预措施
Low-field MRI Scan
MRI Brain scan on the Hyperfine 0.064T Swoop System
干预措施: MRI (Diagnostic Test)
结局指标
主要结局
Proportion of similarly detected lesions on AI-LF-MRI compared to HF-MRI.
时间窗: 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.
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.
时间窗: 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.
次要结局
- Proportion of artefacts on AI-LF-MRI compared to HF-MRI(Baseline assessment (within the study imaging visit))
- Inter-rater agreement on qualitative analysis of AI-LF-MRI vs HF-MRI(Baseline assessment (within the study imaging visit))
- Inter-method agreement on quantitative analysis of AI-LF-MRI vs HF-MRI(Baseline assessment (within the study imaging visit))
- Acceptability of LF-MRI scanning process(Baseline assessment (within the study imaging visit))
- Proportion of scans with clinically significant artefacts, determined by blinded neuroradiologist assessment, on AI-LF-MRI compared with HF-MRI(Baseline assessment (within the study imaging visit))
- 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 raters(Baseline assessment (within the study imaging visit))
- 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))
- Acceptability of the LF-MRI scanning process, assessed using participant responses to a custom acceptability questionnaire(Baseline assessment (within the study imaging visit))