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

NCT ID: NCT07004673

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-12

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Carotid Artery Plaque Ischemic Stroke PET / MR

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Carotid plaque & carotid atherosclerotic stenosis

Medication or carotid stenting or carotid endarterectomy according to clinical guidelines

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jun Liu Jun Liu

Role: STUDY_CHAIR

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

Locations

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

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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JUN LIU Professor

Role: CONTACT

15221303819

BIN LIU PhD student

Role: CONTACT

17317267759

Facility Contacts

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JUN LIU Professor

Role: primary

15221303819

LIU BIN PhD Student

Role: backup

17317267759

Other Identifiers

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18F FDG and 68Ga FAPI PET/MR

Identifier Type: -

Identifier Source: org_study_id

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