18F FDG and 68Ga FAPI PET/MR Imaging of Carotid Artery Plaque Vulnerability: A Clinical Study in Carotid Artery Plaque Patients

Recruiting

• Conditions: Carotid Artery Plaque; Ischemic Stroke; PET / MR

• Registration Number: NCT07004673
• Lead Sponsor: Ruijin Hospital

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04-12
• Study First Submitted: 2025-04-21
• Study First Submitted QC: 2025-05-26
• Last Update Submitted: 2025-05-26
• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-04
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
stroke from baseline to 1months after PET/MR	1 month after PET/MRI	1. Incidence of ipsilateral carotid cerebral infarction Incidence within 1 month of standard drug therapy or carotid stenting or carotid endarterectomy
stroke from baseline to 6 months after PET/MR	6 month after PET/MRI	1. Incidence of ipsilateral carotid cerebral infarction Incidence within 6 month of standard drug therapy or carotid stenting or carotid endarterectomy
stroke from baseline to 12 months after PET/MR	12 month after PET/MRI	1. Incidence of ipsilateral carotid cerebral infarction Incidence within 12 month of standard drug therapy or carotid stenting or carotid endarterectomy
cerebral hemorrhage from baseline to 1months after PET/MR	1 month after PET/MRI	1. Incidence of ipsilateral carotid cerebral hemorrhage Incidence within 1 month of standard drug therapy or carotid stenting or carotid endarterectomy
Lumen patency rate of ipsilateral carotid artery from baseline to 1 months after PET/MR	1 month after PET/MRI	1、The rate of ipsilateral carotid artery lumen patency Observe the rate of lumen patency within 1 month after standard drug therapy or carotid stenting or carotid endarterectomy.
Lumen patency rate of ipsilateral carotid artery from baseline to 6 months after PET/MR	6 month after PET/MRI	1、The rate of ipsilateral carotid artery lumen patency Observe the rate of lumen patency within 6 month after standard drug therapy or carotid stenting or carotid endarterectomy.
Lumen patency rate of ipsilateral carotid artery from baseline to 12 months after PET/MR	12 month after PET/MRI	1、The rate of ipsilateral carotid artery lumen patency Observe the rate of lumen patency within 12 month after standard drug therapy or carotid stenting or carotid endarterectomy.

Secondary Outcome Measures

Name	Time	Method
18F FDG and 68Ga FAPI PET-MRI imaging results from baseline to 1 months after PET/MRI	1month after PET/MRI	1. Changes in metabolic rate of ipsilateral carotid plaque Changes in metabolic rate of 18F FDG and 68Ga FAPI within 1 month after standard drug therapy or carotid stenting or carotid endarterectomy were observed
18F FDG and 68Ga FAPI PET-MRI imaging results from baseline to 6 months after PET/MRI	6 month after PET/MRI	1. Changes in metabolic rate of ipsilateral carotid plaque Changes in metabolic rate of 18F FDG and 68Ga FAPI within 6 month after standard drug therapy or carotid stenting or carotid endarterectomy were observed
18F FDG and 68Ga FAPI PET-MRI imaging results from baseline to 12 months after PET/MRI	12 month after PET/MRI	1. Changes in metabolic rate of ipsilateral carotid plaque Changes in metabolic rate of 18F FDG and 68Ga FAPI within 12 month after standard drug therapy or carotid stenting or carotid endarterectomy were observed

Trial Locations

Locations (1)

Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China