NCT06262217

Mobile MRI for Immediate Radiological Acute Cerebral Lesion Evaluation in Stroke

Mobile MRI for Immediate Radiological Acute Cerebral Lesion Evaluation in Stroke: Investigating the Use of a Small Mobile MRI Scanner to Aid Investigation of Stroke

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: NHS Greater Glasgow and Clyde · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective observational study will evaluate the potential value of mobile MRI in patients with suspected or proven acute stroke and Transient Ischemic Attack (TIA), undertaking additional imaging in the emergency department, acute stroke unit, or outpatient settings, and comparing diagnostic accuracy, Diffusion-weighted imaging (DWI) lesion volume and detection of complications (brain swelling or haemorrhagic transformation). Information on ease of use, tolerability and image quality will also be gathered.

Detailed description

The study will investigate mobile MRI for immediate radiological acute cerebral lesion evaluation in Stroke. The objectives are: 1. Among patients with possible acute minor stroke or TIA, to compare the detection rate of acute DWI lesions on mobile MRI scan with routine imaging, describe number and distribution of lesions, and describe the intervals between mobile MRI and routine diagnostic scan, and time to final clinical diagnosis 2. Among patients with acute stroke of uncertain onset time, to compare the presence of DWI-Fluid attenuated inversion recovery (FLAIR) mismatch pattern on mobile MRI with CT perfusion (CTP) mismatch. 3. Among patients with confirmed acute ischaemic stroke, to compare the volume of DWI lesion on mobile MRI with the core volume on CTP 4. Among patients with established stroke post-thrombolysis or thrombectomy, to compare the incidence of brain swelling and haemorrhagic transformation on mobile MRI with routine imaging 5. In all groups, to evaluate the tolerability and ease of use of the mobile MRI scanner, and to rate image quality

Conditions

• Stroke, Acute

Interventions

Type	Name	Description
DEVICE	Mobile MRI scanner	Use of mobile MRI scanner in patients with suspected or confirmed acute stroke (including Transient Ischaemic attacks)

Timeline

• Start date: 2023-11-11
• Primary completion: 2024-05-31
• Completion: 2024-08-01
• First posted: 2024-02-15
• Last updated: 2024-02-15

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study