Research on the Application of Sigma Radiopharmaceutical FBFP in Cerebral Stroke
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Brain metabolic value
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Poor image quality due to head movement and other reasons during the scanning process.
- •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.
- •Existence of mental and neurological developmental delay.
- •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.
- •Refusal to sign informed consent form during baseline period -
研究组 & 干预措施
Heath control
Heath control received intravenous injection of [18F]FBFP PET/MR under standardized conditions.
Stroke group
Stroke patients received intravenous injection of [18F]FBFP PET/MR under standardized conditions.
干预措施: PET/MR multimodality imaging (Diagnostic Test)
结局指标
主要结局
Brain metabolic value
时间窗: PET/MR examinationDuring MR examination, PET examination was conducted simultaneously. Follow-up visits were conducted at 6 months and 12 months after the examination, including general clinical data of the patients, clinical symptoms, and clinical score
Quantitative detection was performed using an integrated PET/MR scanner. After injecting FBFP at a dose of 1.8 MBq/kg (0.05 mCi/kg), the PET/MR synchronous scan was initiated 60 minutes later and lasted for 30 minutes. Data were collected through a 19-channel head-neck combined coil.
次要结局
未报告次要终点