Stroke AcutePUFFINS 3NCT07004140
Proving Utility of a New Field-cycling MRI Prototype in Acute Stroke Patients
An observational study of Stroke Acute, run by University of Aberdeen at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Acute
- What is being tested?
- 3T MRI research scan, Field-Cycling Imaging research scan and Follow up 3T MRI research scan
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Sep 2025to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with acute stroke admitted to Aberdeen Royal Infirmary.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Aberdeen
Aberdeen, AB25 2ZD
Mary Joan MacLeod, PhD, +44 1224 437842, m.j.macleod@abdn.ac.uk
Gordon D Waiter, PhD, +44 1224 438356, g.waiter@abdn.ac.uk
About this study
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
- Being tested
- 3T MRI research scan, Field-Cycling Imaging research scan, Follow up 3T MRI research scan, Follow up Field-Cycling Imaging research scan, Blood samples for clotting experiments in vitro
- Keywords
- Stroke, Field-Cycling Imaging, FCI
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3T MRI research scanOther
Baseline MRI scan
Field-Cycling Imaging research scanOther
Baseline FCI scan
Follow up 3T MRI research scanOther
Day 30 3T MRI scan
Follow up Field-Cycling Imaging research scanOther
Day 30 FCI scan
Blood samples for clotting experiments in vitroOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Ischaemic stroke | Ischaemic stroke patients within 24 hours from symptom onset Receives: 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 Receives: Other: 3T MRI research scan; Other: Field-Cycling Imaging research scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline at stroke onset
Secondary outcomes (3)
Agreement between extent of haemorrhagic volume obtained from FCI dispersion maps and 3T MRI modalities at baseline
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.
Measured: Baseline at stroke onset
Agreement of infarct core volume measurements obtained from FCI and 3T MRI at day 30 in ischaemic stroke patients
Comparison of infarct core volumes on 30-day 3T FLAIR and baseline/30-day FCI T1 dispersion maps in ischaemic stroke patients.
Measured: 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.
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.
Measured: At baseline and 30 days after stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start16 Sep 2025
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Grampian
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004140
- Sponsor's protocol ID
- 2-001-25
- Other IDs
- 25/SS/0021
- Acronym
- PUFFINS 3
- Status last verified
- Jan 2026
- First submitted
- 26 May 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39189899Senn 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.
PubMed 39955477
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proving Utility of a New Field-cycling MRI Prototype in Acute Stroke Patients
- ClinicalTrials.gov ID
- NCT07004140
- Acronym / sponsor ID
- PUFFINS 3 / 2-001-25
- Conditions
- Stroke Acute
- Keywords
- Stroke, Field-Cycling Imaging, FCI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- NHS Grampian
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischaemic stroke | – | 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 vitroIschaemic stroke patients within 24 hours from symptom onset |
| Haemorrhagic stroke | – | Other: 3T MRI research scan, Other: Field-Cycling Imaging research scanPatients with primary intracerebral haemorrhage within 24 hours from symptom onset |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with acute stroke admitted to Aberdeen Royal Infirmary.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Contraindications to MRI.
- Medically unstable.
- Unable to comprehend or comply with instructions regarding scanning
- Prior mRS of >3.
- Identified for thrombectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3T MRI research scanBaseline MRI scan | Other | Haemorrhagic stroke, Ischaemic stroke |
| Field-Cycling Imaging research scanBaseline FCI scan | Other | Haemorrhagic stroke, Ischaemic stroke |
| Follow up 3T MRI research scanDay 30 3T MRI scan | Other | Ischaemic stroke |
| Follow up Field-Cycling Imaging research scanDay 30 FCI scan | Other | Ischaemic stroke |
| Blood samples for clotting experiments in vitroThrombi 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. | Other | Ischaemic stroke |
Primary outcome
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.
3 secondary outcomes
Agreement between extent of haemorrhagic volume obtained from FCI dispersion maps and 3T MRI modalities at baseline
Time frame: Baseline at stroke onset
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Background: PubMed 39189899Mallikourti 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.
- Background: PubMed 39955477Senn 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke Acute, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Joan MacLeod, PhD (+44 1224 437842, m.j.macleod@abdn.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07004140, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.