18F FDG and 68Ga FAPI PET/MR Imaging of Carotid Artery Plaque Vulnerability: A Clinical Study in Carotid Artery Plaque Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Carotid Artery Plaque, Ischemic Stroke, PET / MR. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Carotid atherosclerotic plaque rupture is the main cause of ischemic stroke attacks, and early and precise assessment of plaque vulnerability can prevent ischemic stroke. High-resolution MRI can reflect vulnerable plaque features such as thin fibrous caps and large lipid cores, but cannot assess their metabolic information; Fibro-activated proteins (FAPs) of PET are specifically expressed in atherosclerosis and suggest vulnerable plaques by reflecting inflammation-induced fibrosis. The aim of this study was to apply 18F FDG\&68Ga-FAPI PET/MR imaging to investigate the vulnerability of carotid atherosclerotic plaques, to obtain quantitative evaluation indexes of active fibrosis within carotid plaques, and to clarify the PET/MR characteristics of unstable plaques in carotid arteries
Primary outcome measures
- stroke from baseline to 1months after PET/MR [Time frame: 1 month after PET/MRI]
- stroke from baseline to 6 months after PET/MR [Time frame: 6 month after PET/MRI]
- stroke from baseline to 12 months after PET/MR [Time frame: 12 month after PET/MRI]
- cerebral hemorrhage from baseline to 1months after PET/MR [Time frame: 1 month after PET/MRI]
- Lumen patency rate of ipsilateral carotid artery from baseline to 1 months after PET/MR [Time frame: 1 month after PET/MRI]
- Lumen patency rate of ipsilateral carotid artery from baseline to 6 months after PET/MR [Time frame: 6 month after PET/MRI]
- Lumen patency rate of ipsilateral carotid artery from baseline to 12 months after PET/MR [Time frame: 12 month after PET/MRI]
Secondary outcome measures (3)
- 18F FDG and 68Ga FAPI PET-MRI imaging results from baseline to 1 months after PET/MRI [Time frame: 1month after PET/MRI]
- 18F FDG and 68Ga FAPI PET-MRI imaging results from baseline to 6 months after PET/MRI [Time frame: 6 month after PET/MRI]
- 18F FDG and 68Ga FAPI PET-MRI imaging results from baseline to 12 months after PET/MRI [Time frame: 12 month after PET/MRI]
Eligibility criteria
Inclusion criteria
-Age between 18 and 80 years; Presence of carotid atherosclerotic plaque confirmed by ultrasound within the past two weeks, with carotid intima-media thickness (IMT) ≥ 2 mm (IMT ≥ 1.2 mm is defined as carotid atherosclerosis) or carotid artery stenosis ≥ 50% as indicated by CTA.
Exclusion criteria
- Absolute or relative contraindications related to PET/MR imaging safety (e.g., metallic implants, MRI phobia, etc.); Patients who have undergone carotid endarterectomy (CEA) or carotid artery stenting (CAS); Pregnant or lactating women; Presence of other vascular diseases, such as vasculitis, moyamoya disease, arterial dissection, etc.; Severe agitation or inability to cooperate with imaging procedures.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT07004673 · 18F FDG and 68Ga FAPI PET/MR