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

N/ANot Yet RecruitingNCT07815860

First Affiliated Hospital of Zhejiang University200 enrolled

Overview

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.

Atherosclerotic lesions contain macrophages expressing stabilin-2 (STAB2), which can be targeted by 18F-S2P. However, conventional vascular imaging modalities mainly reflect the anatomical characteristics of atherosclerotic lesions and have limited ability to assess plaque inflammatory activity, which may affect the identification and risk evaluation of vulnerable plaques. In addition, routine vascular imaging lacks specific molecular biomarkers for evaluating plaque inflammation. 18F-S2P is a novel 18F-labeled peptide tracer targeting STAB2. Preclinical data suggest that 18F-S2P has favorable biodistribution and lesion-targeting properties, with no apparent toxicity observed in animal studies. Patients can undergo PET imaging 0.5 hours after injection without special preparation. Our study will assess the safety profile, image quality, and lesion detection performance of 18F-S2P. Patients with clinically suspected large-artery atherosclerosis will be enrolled in this study.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

200

Conditions

Large-Artery Atherosclerosis (Embolus/Thrombosis)

Interventions

18F-S2PDRUG

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria 1. Aged 40 to 80 years old; 2. Clinically suspected large artery atherosclerosis; 3. Able to understand and comply with all study requirements; 4. 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. Exclusion Criteria 1. Pregnant or breastfeeding female patients; 2. Patients with severe claustrophobia, radiophobia, mental disorders or primary emotional disorders; 3. 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; 4. Subjects received ionizing radiation outside this trial within the past year leading to an annual radiation exposure exceeding 50 mSv; 5. Subjects received any investigational drugs or devices with unconfirmed safety/efficacy within one month before enrollment; 6. Any condition judged by the principal investigator that may bring potential harm to participants during the trial.

Locations (1)

The First Affiliated Hospital of Zhejiang University School of Medicine

Zhejiang, China

Outcomes

Primary Outcomes

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

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

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

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

Central Contacts

Dilibire Adili

CONTACT

86 19916941901 12418731@zju.edu.cn

Data from ClinicalTrials.gov

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