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18F-S2P PET Imaging in the Evaluation of Large Artery Atherosclerosis

ConditionLarge-Artery Atherosclerosis (Embolus/Thrombosis)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorFirst Affiliated Hospital of Zhejiang University

About this trial

The aim of this study is to evaluate the lesion detection performance and safety of 18F-S2P positron emission tomography (PET) in patients with large-artery atherosclerosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 40 to 80 years old;

Clinically suspected large artery atherosclerosis;

Able to understand and comply with all study requirements;

Participants aged ≥65 years with full civil capacity may sign informed consent independently; those with limited civil capacity shall sign the informed consent together with their legal guardians.

Disqualifiers

Pregnant or breastfeeding female patients;

Patients with severe claustrophobia, radiophobia, mental disorders or primary emotional disorders;

Abnormal laboratory indicators at screening: hemoglobin (Hb) <10 g/dL, white blood cell (WBC) <3×10^9/L, platelet (PLT) <90×10^9/L, or creatinine clearance (CrCl) <40 mL/min;

Subjects received ionizing radiation outside this trial within the past year leading to an annual radiation exposure exceeding 50 mSv;

Trial design

Design model

Single group

Treatments tested in this trial

  • 18F-S2P

    Drug

    Patients with large-artery atherosclerosis receive 3.7 MBq/kg of 18F-S2P intravenously followed by PET/CT after 30 min of injection.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: 18F-S2P PET/CT in Large-Artery AtherosclerosisExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Sensitivity of 18F-S2P PET/CT

Sensitivity of 18F-S2P PET/CT for detecting inflammatory atherosclerotic plaques in patients with large-artery atherosclerosis

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

18F-S2P PET performance compared with conventional imaging

Imaging performance of 18F-S2P PET/CT compared with carotid ultrasound

Time frame
up to 24 months
2

18F-S2P PET performance compared with conventional imaging

Imaging performance of 18F-S2P PET/CT compared with magnetic resonance angiography (MRA)

Time frame
up to 24 months
3

Quantitative uptake parameters of 18F-S2P in atherosclerotic plaques

Evaluate 18F-S2P uptake parameters within atherosclerotic lesions

Time frame
through study completion, 3-4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital of Zhejiang University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: