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

NCT07004673 | Recruiting

• 1 other identifier: 18F FDG and 68Ga FAPI PET/MR
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Carotid Artery Plaque; Ischemic Stroke; PET / MR

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (3)

• 18F FDG and 68Ga FAPI PET-MRI imaging results from baseline to 1 months after PET/MRI

  1month after PET/MRI

• 18F FDG and 68Ga FAPI PET-MRI imaging results from baseline to 6 months after PET/MRI

  6 month after PET/MRI

• 18F FDG and 68Ga FAPI PET-MRI imaging results from baseline to 12 months after PET/MRI

  12 month after PET/MRI

Study Arms (1)

Carotid plaque & carotid atherosclerotic stenosis

Medication or carotid stenting or carotid endarterectomy according to clinical guidelines

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Carotid Stenosis; Ischemic Stroke

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke

Study Officials

• Jun Liu Jun Liu

  Department of Neurology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine Study Chair

  STUDY CHAIR

Central Study Contacts

JUN LIU Professor

CONTACT

+86-021-64370045; lj11128@rjh.com.cn

BIN LIU PhD student

CONTACT

+86-021-64370045; ousi@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: June 4, 2025
• Study Start: April 12, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 5, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)