An interventional study of Very-low-field MRI in Stroke, sponsored by Centre Hospitalier St Anne. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Centre Hospitalier St Anne · Not applicable, Interventional, and Diagnostic
The goal of this clinical trial is to learn if a very-low-field MRI scanner (0.064 Tesla), combined with artificial intelligence (AI) image enhancement, can accurately diagnose acute ischemic stroke in adults with suspected stroke. Healthy adult volunteers are also included to optimize image quality. The main questions it aims to answer are:
How accurately does AI-enhanced very-low-field MRI detect ischemic stroke (sensitivity and specificity) compared with standard high-field MRI (3 Tesla)? Does AI enhancement improve diagnostic performance compared with very-low-field MRI images without AI?
Researchers will compare very-low-field MRI images, with and without AI enhancement, to the 3 Tesla MRI performed as part of routine care. Two neuroradiologists will read the images independently, without knowing the results of the other scan.
This study has three parts:
Part 1: healthy volunteers (30 participants). Participants will undergo one 3 Tesla MRI and one very-low-field MRI on the same day (45 minutes maximum).
Part 2: patients with recent stroke, 1 to 7 days after onset (40 participants). Participants will undergo one very-low-field MRI within 6 hours of their routine 3 Tesla MRI.
Part 3: patients with suspected stroke within the last 24 hours (160 participants). Participants will undergo one very-low-field MRI (about 30 minutes) within 4 hours of their routine 3 Tesla MRI, after any emergency treatment. About half will have a second very-low-field MRI around 24 hours later.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 230 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Centre Hospitalier St Anne is the lead sponsor of 101 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All participants:
Part 1 (healthy volunteers):
Part 2 (subacute stroke):
Part 3 (suspected hyperacute stroke):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Very-low-field MRI
Device: Very-low-field MRI
Device: Very-low-field MRI
Brain MRI acquired on a 0.064 Tesla very-low-field scanner, including diffusion-weighted, FLAIR, T1-weighted sequences. Images are reconstructed with and without AI-based enhancement.
Sensitivity of AI-enhanced very-low-field MRI for the diagnosis of acute ischemic stroke
Sensitivity (%) of AI-enhanced very-low-field MRI (0.064 T) for detecting acute ischemic stroke in patients with suspected hyperacute stroke (Part 3), using high-field 3T MRI as the reference standard. Images are read independently by two neuroradiologists blinded to 3T MRI results, with consensus in case of disagreement. Non-interpretable very-low-field MRI scans are classified as negative for stroke.
Time frame: At inclusion (very-low-field MRI performed within 4 hours after 3T MRI)
Specificity of AI-enhanced very-low-field MRI for the diagnosis of acute ischemic stroke
Specificity (%) of AI-enhanced very-low-field MRI (0.064 T) for excluding acute ischemic stroke in patients with suspected hyperacute stroke (Part 3), using high-field 3T MRI as the reference standard. Images are read independently by two neuroradiologists blinded to 3T MRI results, with consensus in case of disagreement. Non-interpretable very-low-field MRI scans are classified as negative for stroke.
Time frame: At inclusion (very-low-field MRI performed within 4 hours after 3T MRI)
Sensitivity and specificity of very-low-field MRI without AI enhancement for acute ischemic stroke
Sensitivity and specificity (%) of non-enhanced very-low-field MRI for acute ischemic stroke, compared with AI-enhanced very-low-field MRI (McNemar test), using 3T MRI as reference.
Time frame: At inclusion (very-low-field MRI performed within 4 hours after 3T MRI)
Diagnostic accuracy of very-low-field MRI for intracranial hemorrhage
Sensitivity and specificity (%) of very-low-field MRI (with and without AI enhancement) for detecting intracranial hemorrhage, using 3T MRI as reference.
Time frame: At inclusion (very-low-field MRI performed within 4 hours after 3T MRI)
Diagnostic accuracy of very-low-field MR angiography for proximal arterial occlusion
Sensitivity and specificity (%) of very-low-field MR angiography for detecting proximal intracranial arterial occlusion, using 3T 3D time-of-flight MR angiography as reference
Time frame: At inclusion (very-low-field MRI performed within 4 hours after 3T MRI)
Diagnostic accuracy of very-low-field MRI for stroke mimics
Proportion (%) of stroke mimics correctly identified on very-low-field MRI, using the final diagnosis based on 3T MRI as reference.
Time frame: At inclusion (very-low-field MRI performed within 4 hours after 3T MRI)
Agreement in ischemic lesion volume between very-low-field and 3T MRI
Ischemic lesion volume (mL) measured on very-low-field and 3T diffusion-weighted images, compared with Pearson correlation and Bland-Altman analysis
Time frame: At inclusion (very-low-field MRI performed within 4 hours after 3T MRI)
Diagnostic accuracy of very-low-field MRI for hemorrhagic transformation
Detection of hemorrhagic transformation (ECASS II classification) on follow-up very-low-field MRI.
Time frame: 24 ± 12 hours after inclusion (patients with follow-up very-low-field MRI)
Intra- and inter-reader agreement
Cohen's kappa coefficients for intra- and inter-reader agreement on the diagnosis of ischemic stroke on very-low-field MRI
Time frame: At inclusion (very-low-field MRI performed within 4 hours after 3T MRI)
Agreement on simulated therapeutic decisions
Agreement (kappa) between simulated treatment decisions made by four reader pairs based on very-low-field MRI and decisions based on 3T MRI
Time frame: At inclusion (very-low-field MRI performed within 4 hours after 3T MRI)
Image quality metrics of AI-enhanced very-low-field MRI
Peak signal-to-noise ratio (PSNR) and structural similarity index (SSIM) of AI-enhanced very-low-field images compared with 3T images.
Time frame: At inclusion (very-low-field MRI performed within 4 hours after 3T MRI)
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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