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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heath control | No Intervention | Heath control received intravenous injection of [18F]FBFP PET/MR under standardized conditions. | |
| Stroke group | Experimental | Stroke patients received intravenous injection of [18F]FBFP PET/MR under standardized conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET/MR multimodality imaging | Diagnostic Test | Application research of Sigma imaging agent FBFP in stroke |
|
| Measure | Description | Time Frame |
|---|---|---|
| Brain metabolic value | 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Lu, Phd | Contact | +86 13309824318 | imaginglu@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jie Lu, Phd | Xuanwu Hospital of Capital Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu hospital | Beijing | Beijing Municipality | 100053 | China |
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| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |