Clinical trial NCT07004140: Proving Utility of a New Field-cycling MRI Prototype in Acute Stroke Patients
Official title: Proving Utility of a New Field-cycling MRI Prototype in Acute Stroke Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stroke Acute
Keywords: Stroke
Field-Cycling Imaging
FCI
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: NHS Grampian
First posted: 2025-06-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with acute stroke admitted to Aberdeen Royal Infirmary.

Brief summary: The goal of this study is to test if a new type of MRI scanner, called Field-Cycling Imaging (FCI), can show changes in the brain within the first day of a stroke due to a blocked blood vessel or bleeding in the brain. The main question it aims to answer is:

• Can FCI identify brain tissue that might recover within the first few hours after a stroke begins?

Participants will undergo a standard MRI scan and an FCI scan, as soon as possible after hospital admission.

Participants who have had a blocked blood vessel will also provide a blood sample and will have a follow up visit at 30 days for repeat of both scans and providing another blood sample.


Eligibility criteria: Inclusion Criteria:

* Acute stroke (\<24 hours from symptom onset).
* NIHSS ≥4 and \<25 with cortical involvement and/or large vessel occlusion on baseline imaging.
* Able to undergo 3T and FCI MRI \<24h of onset.
* With or without thrombolysis.

Exclusion Criteria:

* Contraindications to MRI.
* Medically unstable.
* Unable to comprehend or comply with instructions regarding scanning
* Prior mRS of \>3.
* Identified for thrombectomy.
* Non-stroke pathology or previous cortical infarct on CT scan \> 1/3 of middle cerebral artery territory.

Primary outcomes:
measure: Agreement between extent of ischaemic stroke at-risk tissue/infarct core obtained from FCI dispersion maps and 3T MRI modalities at baseline
timeFrame: Baseline at stroke onset
Secondary outcomes:
measure: Agreement between extent of haemorrhagic volume obtained from FCI dispersion maps and 3T MRI modalities at baseline
timeFrame: Baseline at stroke onset
measure: Agreement of infarct core volume measurements obtained from FCI and 3T MRI at day 30 in ischaemic stroke patients
timeFrame: 30 days after stroke onset
measure: Agreement between T1 dispersion curve measurements obtained from in vivo clot in large intracerebral vessels and clot formed in vitro.
timeFrame: At baseline and 30 days after stroke onset
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: University of Aberdeen
Study officials:
References:
citation: Mallikourti V, Ross PJ, Maier O, Guzman-Gutierrez G, Franko E, Lurie DJ, Broche LM, Macleod MJ. Field-Cycling MRI for Identifying Minor Ischemic Stroke Below 0.2 T. Radiology. 2024 Aug;312(2):e232972. doi: 10.1148/radiol.232972.
citation: Senn N, Ross PJ, Ayde R, Mallikourti V, Krishna A, James C, de Vries CF, Broche LM, Waiter GD, MacLeod MJ. Field-cycling imaging yields repeatable brain R1 dispersion measurement at fields strengths below 0.2 Tesla with optimal fitting routine. MAGMA. 2025 Feb 15. doi: 10.1007/s10334-025-01230-w. Online ahead of print.