FDG and FAPI PET/MR scans to detect vulnerable carotid plaques
18F FDG and 68Ga FAPI PET/MR Imaging of Carotid Artery Plaque Vulnerability: A Clinical Study in Carotid Artery Plaque Patients
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07004673 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.