Research on the Application of Sigma Radiopharmaceutical FBFP in Cerebral Stroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorXuanwu Hospital, Beijing
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
PET/MR multimodality imaging
Diagnostic testApplication research of Sigma imaging agent FBFP in stroke
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Heath controlNo intervention 0 interventions
Group B: Stroke groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
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 scoreSponsors and contacts
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Source ClinicalTrials.gov
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