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NCT Number: NCT07004140

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Aberdeen

Aberdeen, AB25 2ZD, United Kingdom

Location status: Recruiting

Location contact

Gordon D Waiter, PhD

CONTACT

[email protected]

+44 1224 438356

Gordon D Waiter, PhD

SUB_INVESTIGATOR

Lionel M Broche, PhD

SUB_INVESTIGATOR

Mary Joan MacLeod, PhD

CONTACT

[email protected]

+44 1224 437842

Mary Joan MacLeod, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3T MRI research scan

Other

Baseline MRI scan

Field-Cycling Imaging research scan

Other

Baseline FCI scan

Follow up 3T MRI research scan

Other

Day 30 3T MRI scan

Follow up Field-Cycling Imaging research scan

Other

Day 30 FCI scan

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.

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

    Time frame: Baseline at stroke onset

    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.

Secondary outcomes

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

    Time frame: Baseline at stroke onset

    Receiver operator curves (ROC) curves comparing extent of haemorrhagic volume obtained from FCI dispersion maps and from 3T MRI modalities at baseline at stroke onset.

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

    Time frame: 30 days after stroke onset

    Comparison of infarct core volumes on 30-day 3T FLAIR and baseline/30-day FCI T1 dispersion maps in ischaemic stroke patients.

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

    Time frame: At baseline and 30 days after stroke onset

    Extent of agreement between quantified T1 dispersion curve measurements obtained from in vivo imaging and benchtop Fast Field Cycling Nuclear Magnetic Resonance (FFC-NMR). Extent of correlation between thrombo-elastography measurements against in vivo measurements of T1 dispersion.

Study contacts

Contact information is provided by the study sponsor or research team.

Gordon D Waiter, PhD

CONTACT

[email protected]

+44 1224 438356

Mary Joan MacLeod, PhD

CONTACT

[email protected]

+44 1224 437842

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Collaborators

  • NHS Grampian

Registry information

Acronym: PUFFINS 3

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2025
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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