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NCT Number: NCT07004673

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

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Key information

Conditions

Carotid Artery Plaque Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases PET / MR Stroke Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. stroke from baseline to 1months after PET/MR

    Time frame: 1 month after PET/MRI

    • Incidence of ipsilateral carotid cerebral infarction Incidence within 1 month of standard drug therapy or carotid stenting or carotid endarterectomy

  2. stroke from baseline to 6 months after PET/MR

    Time frame: 6 month after PET/MRI

    • Incidence of ipsilateral carotid cerebral infarction Incidence within 6 month of standard drug therapy or carotid stenting or carotid endarterectomy

  3. stroke from baseline to 12 months after PET/MR

    Time frame: 12 month after PET/MRI

    • Incidence of ipsilateral carotid cerebral infarction Incidence within 12 month of standard drug therapy or carotid stenting or carotid endarterectomy

  4. cerebral hemorrhage from baseline to 1months after PET/MR

    Time frame: 1 month after PET/MRI

    • Incidence of ipsilateral carotid cerebral hemorrhage Incidence within 1 month of standard drug therapy or carotid stenting or carotid endarterectomy

  5. Lumen patency rate of ipsilateral carotid artery from baseline to 1 months after PET/MR

    Time frame: 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.

  6. Lumen patency rate of ipsilateral carotid artery from baseline to 6 months after PET/MR

    Time frame: 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.

  7. Lumen patency rate of ipsilateral carotid artery from baseline to 12 months after PET/MR

    Time frame: 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 outcomes

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

    Time frame: 1month after PET/MRI

    • 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

  2. 18F FDG and 68Ga FAPI PET-MRI imaging results from baseline to 6 months after PET/MRI

    Time frame: 6 month after PET/MRI

    • 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

  3. 18F FDG and 68Ga FAPI PET-MRI imaging results from baseline to 12 months after PET/MRI

    Time frame: 12 month after PET/MRI

    • 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

Study contacts

Contact information is provided by the study sponsor or research team.

BIN LIU PhD student

CONTACT

[email protected]

+86-021-64370045

JUN LIU Professor

CONTACT

[email protected]

+86-021-64370045

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • National Natural Science Foundation of China

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2025
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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