Clinical trial NCT07004673: 18F FDG and 68Ga FAPI PET/MR Imaging of Carotid Artery Plaque Vulnerability: A Clinical Study in Carotid Artery Plaque Patients
Official title: 18F FDG and 68Ga FAPI PET/MR Imaging of Carotid Artery Plaque Vulnerability: A Clinical Study in Carotid Artery Plaque Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carotid Artery Plaque
Ischemic Stroke
PET / MR
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2025-06-04
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included a total of 100 patients with internal carotid artery atherosclerosis, divided into 50 cases in the symptomatic group and 50 cases in the asymptomatic group.

Brief summary: 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


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.

Primary outcomes:
measure: stroke from baseline to 1months after PET/MR
timeFrame: 1 month after PET/MRI
measure: stroke from baseline to 6 months after PET/MR
timeFrame: 6 month after PET/MRI
measure: stroke from baseline to 12 months after PET/MR
timeFrame: 12 month after PET/MRI
measure: cerebral hemorrhage from baseline to 1months after PET/MR
timeFrame: 1 month after PET/MRI
measure: Lumen patency rate of ipsilateral carotid artery from baseline to 1 months after PET/MR
timeFrame: 1 month after PET/MRI
measure: Lumen patency rate of ipsilateral carotid artery from baseline to 6 months after PET/MR
timeFrame: 6 month after PET/MRI
measure: Lumen patency rate of ipsilateral carotid artery from baseline to 12 months after PET/MR
timeFrame: 12 month after PET/MRI
Secondary outcomes:
measure: 18F FDG and 68Ga FAPI PET-MRI imaging results from baseline to 1 months after PET/MRI
timeFrame: 1month after PET/MRI
measure: 18F FDG and 68Ga FAPI PET-MRI imaging results from baseline to 6 months after PET/MRI
timeFrame: 6 month after PET/MRI
measure: 18F FDG and 68Ga FAPI PET-MRI imaging results from baseline to 12 months after PET/MRI
timeFrame: 12 month after PET/MRI
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Department of Neurology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine Study Chair
name: Jun Liu Jun Liu
role: STUDY_CHAIR
References: