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Not yet recruitingNCT07815860Updated Sep 11, 2026

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

An interventional study of 18F-S2P in Large-Artery Atherosclerosis (Embolus/Thrombosis), sponsored by First Affiliated Hospital of Zhejiang University. Not yet recruiting at 1 site in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by First Affiliated Hospital of Zhejiang University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
40 Years to 80 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Large-Artery Atherosclerosis (Embolus/Thrombosis)
03

In context

Embolism

104 studies on the registry are indexed under Embolism; 14 are open to participants now.

This study's planned enrollment of 200 is above the median of 150 across 61 interventional studies indexed under Embolism.

Browse Embolism studies →

Lead sponsor

First Affiliated Hospital of Zhejiang University is the lead sponsor of 263 studies on the registry; 144 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 independently; those with limited civil capacity shall sign the informed consent together with their legal guardians.

Exclusion criteria

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: (Hb) \<10 g/dL, white blood cell (WBC) \<3×10\^9/L, (PLT) \<90×10\^9/L, or (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 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    18F-S2P PET/CT in Large-Artery Atherosclerosis

    Each patient receives a single intravenous injection of 18F-S2P 3.7 MBq/kg and undergoes PET/CT scan after 30 min post-injection.

    Drug: 18F-S2P

Interventions

  • Drug18F-S2P

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

06

What researchers measure

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

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Study locations

1 site
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07815860
Responsible party
Sponsor
First posted
Sep 11, 2026
Start date
Sep 2026 (estimated)
Primary completion
Sep 2029 (estimated)
Completion
Sep 2031 (estimated)
Last update
Sep 11, 2026

Study contacts

Dilibire Adili
Contact
12418731@zju.edu.cn
86 19916941901

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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