PET/MR multimodal analysis of brain blood flow and metabolism in carotid ischemia

PET/MR Multimodal Quantitative Imaging of Cerebral Ischemia With CBF and CMRGlc Assessment in Cephalo-Carotid Atherosclerosis

This project uses combined PET and MRI scans to test whether measuring cerebral blood flow and glucose metabolism helps guide diagnosis and treatment for people with significant carotid artery narrowing who had a recent ischemic stroke or TIA.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years to 80 Years
• Sex: Male
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07079345 on ClinicalTrials.gov

What this trial studies

This observational study will enroll 200 patients with unilateral anterior circulation carotid stenosis (>70%) who had a TIA or ischemic stroke in the affected territory more than 3 weeks but within 12 months. Participants will undergo PET/MR multimodal imaging at enrollment and have data collected again at 6- and 12-month follow-ups while receiving standard medical or surgical care. The project aims to optimize non-invasive quantitative algorithm models for cerebral blood flow (CBF) and cerebral metabolic rate of glucose (CMRGlc), identify new imaging markers, and relate quantitative metrics to clinical and treatment outcomes. Strict image quality control and exclusion of other neurologic disorders are used to ensure reliable quantitative measurements.

Who should consider this trial

Good fit: Adults with unilateral anterior circulation carotid artery stenosis >70% who experienced a TIA or ischemic stroke in the affected territory within the past 12 months (and at least 3 weeks since the last event) and who can undergo PET/MR and follow scheduled follow-ups.

Not a fit: Patients with poor scan quality, other neurologic diseases that cause brain dysfunction, posterior circulation or bilateral high-grade stenosis, or inability to complete PET/MR imaging and follow-up visits are unlikely to benefit.

Why it matters

Potential benefit: If successful, this could provide better non-invasive imaging markers to personalize treatment decisions and monitor recovery for patients with carotid atherosclerosis and ischemic events.

How similar studies have performed: Prior PET and MRI studies have shown promise in mapping cerebral perfusion and metabolism, but fully integrated quantitative PET/MR models for guiding treatment in carotid stenosis remain relatively novel and are still being validated.

Eligibility criteria

Inclusion Criteria:

1. Angiography diagnosed unilateral anterior circulation head carotid artery stenosis, the diameter of the tube was reduced by \>70%, and the contralateral anterior circulation and bilateral posterior circulation did not exceed the stenosis of \>50% of the diameter reduction;
2. Must have had a transient ischemic attack or ischemic stroke within the area of the diseased vessel within the past 12 months, with the most recent onset being more than 3 weeks;
3. MRI showed no new infarct lesions in the skull;
4. There is no infarct lesion in the previous pontine area;
5. Research participants and informants can complete relevant examinations and follow-ups;
6. Informed consent signed by the study participant or his/her authorized representative;

Exclusion Criteria:

1. Poor image quality caused by head movement or other reasons during scanning
2. Presence of other neurological diseases that can cause brain dysfunction (such as depression, brain tumor, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, brain trauma, normal pressure hydrocephalus, etc.)
3. Presence of other systemic diseases that can cause cognitive impairment, such as hepatic insufficiency, renal insufficiency, thyroid dysfunction, severe anemia, folic acid and vitamin B12 deficiency, specific infections (such as syphilis, HIV), alcohol and drug abuse, etc
4. Presence of other known diseases that may cause cognitive impairmentPresence of other known diseases that may cause cognitive impairment
5. Individuals with severe visual or hearing impairment, claustrophobia, or other conditions that prevent cooperation with MRI examination
6. Individuals suffering from diseases that make it impossible to cooperate with cognitive examinations
7. Refusal to sign the informed consent form at baseline

Where this trial is running

Beijing

• Xuanwu Hospitail, Capital Medical University — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Bixiao Cui

Conditions PET/MR; Stroke Ischemic