Brain scan with a new imaging agent in people who had a stroke
Tests a PET/MR imaging agent in stroke patients compared with healthy people.
Plain-language title generated from the registry record
Registry title: Research on the Application of Sigma Radiopharmaceutical FBFP in Cerebral Stroke
Key facts
- Where
- Beijing, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who had a stroke or mini-stroke linked to a narrowed artery on one side of the brain. It also takes healthy volunteers as a comparison group.
- Age
- 18 to 99 years
- Sex
- All sexes
- Disease stage
- Stroke or transient ischemic attack (mini-stroke) in the past 12 months, with one narrowed artery in the front part of the brain (more than 70% narrowing). The most recent attack lasted more than 3 weeks. No stenosis of more than 50% on the other side or in the back arteries. No new brain infarction on MRI.
- Biomarker or test result
- PET/MR imaging must show blood flow or metabolism in the affected side of the brain reduced by more than 10% compared with the other side.
Main reasons for not taking part
- Other brain or nerve diseases, such as brain tumor, Parkinson's disease, epilepsy or encephalitis
- Other illnesses that can affect thinking, such as liver, kidney or thyroid problems, or alcohol and drug abuse
- Mental or nerve development delay
- Cannot cooperate with MRI, for example because of claustrophobia or severe vision or hearing problems
- Refusal to sign the informed consent form
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Source: NCT07558577, who can take part
Where in China
- Xuanwu HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Xuanwu Hospital, Beijing
- Trial code
- NCT07558577
- Record updated
- 30 April 2026
- Original description
This clinical research, aims to investigate the uptake of [18F]FBFP, a Sigma-1 receptor (Sig 1R) PET imaging agent, in stroke participants, compare differences with healthy controls, and evaluate its diagnostic efficacy, providing objective basis for clinical diagnosis and treatment.Read full original descriptionShow less
Research on the Application of Sigma Radiopharmaceutical FBFP in Cerebral Stroke
This clinical research, aims to investigate the uptake of [18F]FBFP, a Sigma-1 receptor (Sig 1R) PET imaging agent, in stroke participants, compare differences with healthy controls, and evaluate its diagnostic efficacy, providing objective basis for clinical diagnosis and treatment.
The study will recruit 30 stroke participants (with specific inclusion criteria for unilateral ICA stenosis cases) and 20 gender- and age-matched healthy controls from January 2025 to December 2026. Exclusion criteria cover various neurological and systemic diseases that may affect results, as well as conditions preventing cooperation with examinations.
No intervention measures are involved. Follow-ups will be conducted at 6 and 12 months to collect clinical data and observe neurological symptom progression. Key measurements include clinical information (via questionnaires and scales like NIHSS and mRS) and PET/MR imaging data (analyzed using PMOD software to calculate SUVmean and uptake differences with cerebellar cortex as reference).
Statistical analysis will use SPSS 21.0, applying descriptive statistics, t-test, ANOVA, regression models, ROC curves, etc., with P < 0.05 as significant. Safety evaluation notes PET/MR radiation dose (3-5mSv) is much lower than the safe threshold.
Participant protection includes ethical approval, informed consent, voluntary participation, risk disclosure, no fees for related exams, and privacy protection. The research team and institution have sufficient resources and qualifications, with outputs including a clinical research cohort and a high-quality paper.
Inclusion: Angiography diagnosis shows unilateral anterior circulation head and neck artery stenosis with a diameter reduction of>70%, and there is no stenosis in the contralateral anterior circulation or bilateral posterior circulation with a diameter reduction of>50%; Transient ischemic attack or ischemic stroke that must have occurred within the past 12 months in the affected vascular area, with the most recent attack lasting more than 3 weeks; MRI shows no new intracranial infarction lesions; No previous infarction lesions in the pontine area; Either PET/MR blood flow or metabolic imaging shows reduced blood flow and metabolism in the affected hemisphere, with a reduction rate exceeding 10% compared to the contralateral region; Subjects and informants can complete relevant examinations and follow-up work; The subject or their authorized representative signs the informed consent form.
Exclusion: There are other neurological disorders that can cause brain dysfunction, such as depression, brain tumors, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, traumatic brain injury, normal intracranial pressure hydrocephalus, etc; There are other systemic diseases that can cause cognitive impairment, such as liver dysfunction, kidney dysfunction, thyroid dysfunction, severe anemia, folate and vitamin B12 deficiency, special infections (such as syphilis, HIV), alcohol and drug abuse, etc; There are other known diseases that may cause cognitive impairment; Individuals with severe visual and hearing impairments, claustrophobia, and other conditions who cannot cooperate with MRI examinations; Suffering from diseases that prevent cooperation in completing cognitive examinations; Poor image quality due to head movement and other reasons during the scanning process; Existence of mental and neurological developmental delay; Refusal to sign informed consent form during baseline period -.