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PET-MRI Imaging in Patients With Symptomatic Carotid Artery Stenosis

Hybrid 18F-fluoride Positron Emission Tomography-Magnetic Resonance Imaging in Patients With Symptomatic Carotid Artery Stenosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03215550
Enrollment
20
Registered
2017-07-12
Start date
2017-10-12
Completion date
2020-01-10
Last updated
2020-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Carotid Stenosis

Keywords

atherosclerosis, imaging

Brief summary

Ischaemic stroke is a major cause of death and disability worldwide. In patients with recent stroke, the 18F-fluoride positron emission tomography-computed tomography highlights high-risk culprit carotid plaque and is more discriminatory than 18F-fluorodeoxyglucose. Using hybrid positron emission tomography-magnetic resonance imaging investigators propose to build upon these findings by prospectively assessing 18F-fluoride uptake in a broad range of patients with acute transient ischaemic attack or ischaemic stroke. Investigators will specifically examine the association of 18F-fluoride uptake with multiparametric magnetic resonance imaging assessments of atherosclerotic plaque, especially the role of thrombus and lipid. Finally, using transcranial Doppler and diffusion-weighted magnetic resonance brain imaging, an assessment of the functional consequences of 18F-fluoride-positive atherosclerotic plaque will be performed. If successful, this technique has a number of valuable translational applications including the better selection of patients for carotid intervention.

Detailed description

The ability to identify the culprit carotid plaque represents a key goal in carotid artery imaging. Although an array of non-invasive imaging techniques can detect a wide spectrum of complementary high-risk characteristics, no single modality can reliably identify vulnerable plaques associated with future stroke development. Substantial histological data suggests that specific plaque components identify patients at high-risk for future ipsilateral stroke and cardiovascular events. This implies that investigators need to look beyond the traditional paradigm where the basis for carotid endarterectomy were formulated by an invasive imaging modality that provided no information on the arterial wall composition. Alternative imaging strategies are therefore required targeting not only in vivo carotid morphology but also plaque biology and disease activity. This is fundamental to optimal risk-stratification and appropriate selection of patients for high-risk vascular intervention. One new approach is to use non-invasive molecular imaging targeted at plaque biology using hybrid systems such as positron emission tomography-magnetic resonance imaging.

Interventions

PROCEDURECEA

Carotid Endarterectomy

RADIATION18F PET-MRI

18F-fluoride Hybrid PET-MRI

DIAGNOSTIC_TESTTranscranial Doppler

Microembolic Signals detection

Sponsors

University of Edinburgh
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Patients with carotid artery stenosis (\>50% for men and \>70% for women, by NASCET criteria) above 40 years of age.

Exclusion criteria

* Patients with new stroke and a modified Rankin score \>3 * Chronic kidney disease with an estimated Glomerular Filtration Rate (eGFR) of \<30 ml/min/1.73 m2 * Atrial fibrillation * Pregnant women * Prior ipsilateral carotid intervention * Prior neck radiotherapy * Inability to tolerate the supine position * Participation in the study would result in delay to surgery * Psychiatric illness/social situations that would limit compliance with study requirements * History of allergic reaction attributed to 18F-fluoride * History of allergic reaction to gadolinium contrast media * Metal implants and devices including pacemakers and defibrillators

Design outcomes

Primary

MeasureTime frameDescription
18F-fluoride uptake in the culprit plaque in carotid, aortic and intra-cranial vessels.2 weeks18F-fluoride uptake will be measured by the mean and max Standardised Uptake Values (SUV) derived from the culprit atherosclerotic plaques.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026