Not yet recruitingNCT07930013ClinicalTrials.gov record

Very-Low-Field MRI for the Diagnosis of Acute Stroke

Stroke

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THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Interventional
Phase: Not applicable
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Accepted
Participants: 230 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

All participants:

Age 18 years or older
Affiliated with or beneficiary of a social security scheme

Part 1 (healthy volunteers):

No known neurological disease
Written informed consent
Registered in the national file of healthy volunteers (VRB)

Part 2 (subacute stroke):

Confirmed acute ischemic stroke on 3T MRI
Symptom onset 1 to 7 days before inclusion
Very-low-field MRI feasible within 6 hours of 3T MRI
Written informed consent

Part 3 (suspected hyperacute stroke):

Clinical suspicion of acute stroke with symptom onset within 24 hours
3T MRI performed as part of routine care
Very-low-field MRI feasible within 4 hours of 3T MRI, during working hours (8 a.m.-6 p.m.)
Informed consent from the patient, or, if the patient is unable to consent, from a relative, the trusted person or an independent physician (emergency procedure, Article L.1122-1-3 of the French Public Health Code), followed by the patient's consent to continue as soon as possible

Exclusion Criteria:

Contraindication to MRI (e.g., non-MRI-compatible pacemaker or implanted device, metallic foreign body)
Pregnancy or breastfeeding
Clinical instability incompatible with an additional MRI examination
Inability to remain still for the duration of the examination
Adults under legal protection (guardianship or curatorship), unless allowed by the protocol
Participation in another interventional study that may interfere with this study

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not randomized
Masking: Single masked

Part 1 - Healthy volunteers

Not reported in this registry record.

Device: Very-low-field MRI

Part 2 - Subacute stroke patients

Not reported in this registry record.

Device: Very-low-field MRI

Part 3 - Suspected hyperacute stroke patients

Not reported in this registry record.

Device: Very-low-field MRI

Very-low-field MRI DEVICE

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.

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