Large-Artery Atherosclerosis (Embolus/Thrombosis)NCT07815860
18F-S2P PET Imaging in the Evaluation of Large Artery Atherosclerosis
A study testing 18F-S2P in people with Large-Artery Atherosclerosis (Embolus/Thrombosis), run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Large-Artery Atherosclerosis (Embolus/Thrombosis)
- What is being tested?
- 18F-S2P
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
- Subjects received any investigational drugs or devices with unconfirmed safety/efficacy within one month before enrollment;
- Any condition judged by the principal investigator that may bring potential harm to participants during the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Zhejiang University School of Medicine
Zhejiang
Xinhui Su, 86 13806071262, suxinhui@zju.edu.cn
Dilibire Adili, 86 19916941901, 12418731@zju.edu.cn
About this study
Official title: A Prospective Clinical Study of 18F-S2P-Targeted STAB2 Receptor PET Imaging in the Diagnosis of Large Artery Atherosclerosis
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.
- Being tested
- 18F-S2P
- Medical subject headings
- Embolism, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 18F-S2P PET/CT in Large-Artery Atherosclerosis | Experimental | Each patient receives a single intravenous injection of 18F-S2P 3.7 MBq/kg and undergoes PET/CT scan after 30 min post-injection. Receives: Drug: 18F-S2P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of 18F-S2P PET/CT
Sensitivity of 18F-S2P PET/CT for detecting inflammatory atherosclerotic plaques in patients with large-artery atherosclerosis
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
18F-S2P PET performance compared with conventional imaging
Imaging performance of 18F-S2P PET/CT compared with carotid ultrasound
Measured: 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)
Measured: up to 24 months
Quantitative uptake parameters of 18F-S2P in atherosclerotic plaques
Evaluate 18F-S2P uptake parameters within atherosclerotic lesions
Measured: through study completion, 3-4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large-Artery Atherosclerosis (Embolus/Thrombosis)Studies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815860
- Sponsor's protocol ID
- S2P-AS
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study of 18F-S2P-Targeted STAB2 Receptor PET Imaging in the Diagnosis of Large Artery Atherosclerosis
- ClinicalTrials.gov ID
- NCT07815860
- Acronym / sponsor ID
- S2P-AS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-S2P PET/CT in Large-Artery Atherosclerosis | Experimental | Drug: 18F-S2PEach patient receives a single intravenous injection of 18F-S2P 3.7 MBq/kg and undergoes PET/CT scan after 30 min post-injection. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
- Subjects received any investigational drugs or devices with unconfirmed safety/efficacy within one month before enrollment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-S2PPatients with large-artery atherosclerosis receive 3.7 MBq/kg of 18F-S2P intravenously followed by PET/CT after 30 min of injection. | Drug | 18F-S2P PET/CT in Large-Artery Atherosclerosis |
Primary outcome
Sensitivity of 18F-S2P PET/CT
Time frame: through study completion, an average of 1 year
Sensitivity of 18F-S2P PET/CT for detecting inflammatory atherosclerotic plaques in patients with large-artery atherosclerosis
3 secondary outcomes
18F-S2P PET performance compared with conventional imaging
Time frame: up to 24 months
18F-S2P PET performance compared with conventional imaging
Time frame: up to 24 months
Quantitative uptake parameters of 18F-S2P in atherosclerotic plaques
Time frame: through study completion, 3-4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-S2P in people with Large-Artery Atherosclerosis (Embolus/Thrombosis), run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dilibire Adili (86 19916941901, 12418731@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of 18F-S2P PET/CT (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.