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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorRuijin Hospital

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: Carotid plaque & carotid atherosclerotic stenosis

Trial outcomes

Primary outcomes

1

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

Time frame
1 month after PET/MRI
2

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

Time frame
6 month after PET/MRI
3

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

Time frame
12 month after PET/MRI
4

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

Time frame
1 month after PET/MRI

Secondary outcomes

1

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

Time frame
1month after PET/MRI
2

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

Time frame
6 month after PET/MRI
3

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

Time frame
12 month after PET/MRI

Other outcomes

Sponsors and contacts

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Ruijin Hospital

Lead sponsor

National Natural Science Foundation of China

Collaborator