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ID07004673

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

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo PET/MR imaging to assess carotid artery plaque vulnerability.

1 imaging visit (in-person)

Long-term Monitoring

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

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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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