Actively Recruiting
18F FDG and 68Ga FAPI PET/MR Imaging of Carotid Artery Plaque Vulnerability: A Clinical Study in Carotid Artery Plaque Patients
Led by Ruijin Hospital · Updated on 2026-03-05
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Ruijin Hospital
Lead Sponsor
N
National Natural Science Foundation of China
Collaborating Sponsor
AI-Summary
What this Trial Is About
Carotid artery plaque rupture is a leading cause of ischemic stroke, and early, accurate assessment of plaque vulnerability can help prevent these strokes. Researchers are studying the use of 18F FDG and 68Ga-FAPI PET/MR imaging to investigate features of vulnerable carotid plaques, such as active fibrosis and inflammation, which may better identify unstable plaques compared to standard MRI alone. This observational study aims to clarify imaging characteristics linked to plaque instability in patients with carotid artery plaques. Participants will undergo 18F FDG and 68Ga-FAPI PET/MR scans to assess metabolic and structural plaque features. Treatments such as medication, carotid stenting, or carotid endarterectomy will follow clinical guidelines but are not assigned by the study. The study focuses on evaluating plaque vulnerability through advanced imaging rather than testing specific treatments. During the study, participants will be monitored for stroke and cerebral hemorrhage at 1, 6, and 12 months after their PET/MR scan. Researchers will also assess the openness of the carotid artery (lumen patency rate) and analyze imaging results at these same time points. This approach aims to track plaque changes and clinical outcomes over one year to better understand plaque behavior and risk.
CONDITIONS
Brief Title
18F FDG and 68Ga FAPI PET/MR Imaging of Carotid Artery Plaque Vulnerability: A Clinical Study in Carotid Artery Plaque Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Presence of carotid atherosclerotic plaque confirmed by ultrasound within the past two weeks
- Carotid intima-media thickness (IMT) of 2 mm or more, or carotid artery stenosis of 50% or more as shown by CTA
You will not qualify if you...
- Absolute or relative contraindications to PET/MR imaging (e.g., metallic implants, MRI phobia)
- Previous carotid endarterectomy or carotid artery stenting
- Pregnant or lactating women
- Presence of other vascular diseases such as vasculitis, moyamoya disease, or arterial dissection
- Severe agitation or inability to cooperate with imaging procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo PET/MR imaging to assess carotid artery plaque vulnerability.
1 imaging visit (in-person)
Duration - 12 months
Participants are observed for stroke occurrence, cerebral hemorrhage, and carotid artery status for up to 12 months after imaging.
Follow-up visits at 1 month, 6 months, and 12 months after imaging
Trial Site Locations
Total: 1 location
1
Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
J
JUN LIU Professor
B
BIN LIU PhD student
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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