Proving Utility of a New Field-cycling MRI Prototype in Acute Stroke Patients

NCT07004140 | Recruiting

• 2 other identifiers: 2-001-2525/SS/0021
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Acute

Keywords

Stroke; Field-Cycling Imaging; FCI

Outcome Measures

Primary Outcomes (1)

• Agreement between extent of ischaemic stroke at-risk tissue/infarct core obtained from FCI dispersion maps and 3T MRI modalities at baseline

  Receiver operator curves (ROC) curves comparing extent of at-risk tissue/infarct core obtained from FCI dispersion maps and from 3T MRI modalities at baseline at stroke onset.

  Baseline at stroke onset

Secondary Outcomes (3)

• Agreement between extent of haemorrhagic volume obtained from FCI dispersion maps and 3T MRI modalities at baseline

  Baseline at stroke onset

• Agreement of infarct core volume measurements obtained from FCI and 3T MRI at day 30 in ischaemic stroke patients

  30 days after stroke onset

• Agreement between T1 dispersion curve measurements obtained from in vivo clot in large intracerebral vessels and clot formed in vitro.

  At baseline and 30 days after stroke onset

Study Arms (2)

Ischaemic stroke

Ischaemic stroke patients within 24 hours from symptom onset

Other: 3T MRI research scan; Other: Field-Cycling Imaging research scan; Other: Follow up 3T MRI research scan; Other: Follow up Field-Cycling Imaging research scan; Other: Blood samples for clotting experiments in vitro

Haemorrhagic stroke

Patients with primary intracerebral haemorrhage within 24 hours from symptom onset

Other: 3T MRI research scan; Other: Field-Cycling Imaging research scan

Interventions

Follow up Field-Cycling Imaging research scan OTHER

Day 30 FCI scan

Ischaemic stroke

Blood samples for clotting experiments in vitro OTHER

Thrombi from whole blood from ischaemic stroke patients will be formed and examined using bench top nuclear magnetic resonance (NMR) assays. At baseline and 30 days after stroke onset.

Ischaemic stroke

3T MRI research scan OTHER

Baseline MRI scan

Haemorrhagic stroke; Ischaemic stroke

Follow up 3T MRI research scan OTHER

Day 30 3T MRI scan

Ischaemic stroke

Field-Cycling Imaging research scan OTHER

Baseline FCI scan

Haemorrhagic stroke; Ischaemic stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with acute stroke admitted to Aberdeen Royal Infirmary.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aberdeen: lead
• NHS Grampian: collaborator

Study Sites (1)

University of Aberdeen

Aberdeen, AB25 2ZD, United Kingdom

RECRUITING

Related Publications (2)

• 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.

  PMID: 39189899 BACKGROUND

• 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 Jul;38(3):465-474. doi: 10.1007/s10334-025-01230-w. Epub 2025 Feb 15.

  PMID: 39955477 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Blood Specimen Collection; In Vitro Techniques

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Mary Joan MacLeod, PhD

CONTACT

+44 1224 437842; m.j.macleod@abdn.ac.uk

Gordon D Waiter, PhD

CONTACT

+44 1224 438356; g.waiter@abdn.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start: September 16, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

GB (1)