FDG and FAPI PET/MR scans to detect vulnerable carotid plaques
Official title: 18F FDG and 68Ga FAPI PET/MR Imaging of Carotid Artery Plaque Vulnerability: A Clinical Study in Carotid Artery Plaque Patients
Run by Ruijin Hospital · NCT07004673 · Data updated 2026-11-12
This project will try FDG and FAPI PET/MR scans to see if they can identify active, unstable carotid artery plaques in adults with carotid atherosclerosis to help prevent strokes.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | April 12, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | March 5, 2026 |
| Trial ID | NCT07004673 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–80 with carotid atherosclerotic plaque confirmed by ultrasound within two weeks (IMT ≥ 2 mm or CTA showing ≥ 50% stenosis) who can safely undergo PET/MR imaging are ideal candidates.
✕Probably not a fit
Patients who have had carotid endarterectomy or stenting, have contraindications to PET/MR (including metallic implants or severe claustrophobia), are pregnant or lactating, or have other vascular diseases such as vasculitis or dissection are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational imaging study will recruit adults with carotid atherosclerotic plaque confirmed by recent ultrasound or CTA and perform combined 18F-FDG and 68Ga-FAPI PET/MR scans. The scans aim to provide metabolic and structural information by measuring inflammation-related FDG uptake and fibrosis-related FAPI uptake alongside high-resolution MR plaque features. Quantitative PET/MR indexes of active fibrosis and metabolic activity within plaques will be obtained and correlated with MR markers of vulnerability such as thin fibrous cap and large lipid core. The study seeks to characterize imaging signatures that distinguish unstable from stable carotid plaques without introducing interventional treatments.
Why it matters
Potential benefit: If successful, this approach could allow earlier and more precise identification of high-risk carotid plaques, which may help guide preventive treatment and reduce stroke risk.
How similar studies have gone: FDG PET has previously shown promise imaging plaque inflammation while 68Ga-FAPI is a newer tracer for fibrosis with limited but emerging clinical data suggesting it may identify active fibrotic processes in atherosclerosis.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: -Age between 18 and 80 years; Presence of carotid atherosclerotic plaque confirmed by ultrasound within the past two weeks, with carotid intima-media thickness (IMT) ≥ 2 mm (IMT ≥ 1.2 mm is defined as carotid atherosclerosis) or carotid artery stenosis ≥ 50% as indicated by CTA. Exclusion Criteria: * 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.
Where it's running
-
Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: JUN LIU Professor
- Email: lj11128@rjh.com.cn
- Phone: +86-021-64370045
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals
This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.
-
Remote ischemic conditioning for post-stroke insomnia
A 136-person, randomized study will test whether a non-invasive arm-cuff procedure done twice daily for 90 days can improve sleep after a first ischemic stroke in adults 18–80.
-
Ear-based nerve stimulation to help sleep after a stroke
A device that delivers vagal nerve stimulation through the ear is tested to see if it helps stroke patients in rehab sleep better.
-
Theta Burst Stimulation to Help Stroke Recovery (Upper and Lower Limbs)
This trial tests whether applying theta burst stimulation to the motor cortex, in combination with standard rehabilitation, helps people over 45 who recently had a first ischemic stroke recover arm and leg movement.
-
Preventing another ischemic stroke with a smart bracelet and app
This study tests whether a digital prevention program using a wearable and a mobile app can help people who recently had an ischemic stroke reduce the chance of another stroke and improve risk-factor control.
-
Photon-counting CT to check intracranial stents
This study tests whether ultra-high-resolution photon-counting CT can reliably visualize intracranial stents and detect in-stent restenosis during follow-up of patients with prior stents.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.