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

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

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: JUN LIU Professor; Phone Number: +86-021-64370045; Email: lj11128@rjh.com.cn
• Study Contact Backup: Name: BIN LIU PhD student; Phone Number: +86-021-64370045; Email: ousi@163.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200025
      • Recruiting
      • Department of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
      • Contact: JUN LIU Professor; Phone Number: +86-021-64370045; Email: lj11128@rjh.com.cn
      • Contact: LIU BIN PhD Student; Phone Number: +86-021-64370045; Email: ousi@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Carotid plaque & carotid atherosclerotic stenosis; Medication or carotid stenting or carotid endarterectomy according to clinical guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stroke from baseline to 1months after PET/MR	1. Incidence of ipsilateral carotid cerebral infarction Incidence within 1 month of standard drug therapy or carotid stenting or carotid endarterectomy	1 month after PET/MRI
stroke from baseline to 6 months after PET/MR	1. Incidence of ipsilateral carotid cerebral infarction Incidence within 6 month of standard drug therapy or carotid stenting or carotid endarterectomy	6 month after PET/MRI
stroke from baseline to 12 months after PET/MR	1. Incidence of ipsilateral carotid cerebral infarction Incidence within 12 month of standard drug therapy or carotid stenting or carotid endarterectomy	12 month after PET/MRI
cerebral hemorrhage from baseline to 1months after PET/MR	1. Incidence of ipsilateral carotid cerebral hemorrhage Incidence within 1 month of standard drug therapy or carotid stenting or carotid endarterectomy	1 month after PET/MRI
Lumen patency rate of ipsilateral carotid artery from baseline to 1 months after PET/MR	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.	1 month after PET/MRI
Lumen patency rate of ipsilateral carotid artery from baseline to 6 months after PET/MR	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.	6 month after PET/MRI
Lumen patency rate of ipsilateral carotid artery from baseline to 12 months after PET/MR	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.	12 month after PET/MRI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
18F FDG and 68Ga FAPI PET-MRI imaging results from baseline to 1 months 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	1month after PET/MRI
18F FDG and 68Ga FAPI PET-MRI imaging results from baseline to 6 months 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	6 month after PET/MRI
18F FDG and 68Ga FAPI PET-MRI imaging results from baseline to 12 months 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	12 month after PET/MRI

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: National Natural Science Foundation of China
• Investigators: Study Chair: Jun Liu Jun Liu, Department of Neurology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine Study Chair

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 21, 2025
• First Submitted That Met QC Criteria: May 26, 2025
• First Posted (Actual): June 4, 2025

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases; Stroke; Carotid Artery Diseases; Ischemic Stroke; Carotid Stenosis
• Other Study ID Numbers: 18F FDG and 68Ga FAPI PET/MR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No