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. 2024 Aug 19;11:1425965. doi: 10.3389/fmed.2024.1425965

TABLE 1.

Interventional studies for nuclear medicine applications in ischemic and haemorrhagic stroke diagnosis.

NCT Number Study Title Conditions Interventions Primary & secondary outcome measures Enrollment Study Design Location
NCT 03943966 (18) In vivo thrombus image with 18F-glycoprotein (GP)1, a novel platelet positron emission tomography (PET) radiotracer Stroke, transient ischemic attack (TIA), pulmonary embolism, deep venous thrombosis, atherothrombosis, prosthetic valve thrombosis, myocardial infarction Novel platelet radiotracer (18F-sodium fluoride) PET computed tomography (CT) scan • The ratio of 18F-GP1 standardized uptake values in thrombus, as a marker of necrotic inflammation in human atherosclerosis, compared with the recorded in blood pool
• To express the distribution of glycoprotein IIb/IIIa receptor within the cardiovascular thrombus in arterial and venous circulation within 6 months
73 adults including older adults Randomized, parallel assignment United Kingdom
ISRCTN 15483452 Brown et al. (19) MINocyclinE to reduce inflammation and blood-brain barrier leakage in small vessel disease: a phase II, randomized, double-blind, placebo-controlled trial Cerebral small vessel disease stroke Minocycline antibiotic with anti-inflammatory properties versus placebo PET functional magnetic resonance imaging (fMRI) scan • Reduction in inflammation measured by changes in cerebrospinal fluid biomarkers of inflammation
• PET imaging to assess changes in regional cerebral blood flow and glucose metabolism, changes in clinical symptoms and disability, measured by scales such as the modified ranking scale or National institute of stroke (NIH) scale, assessed changes in brain function/structure using advanced imaging techniques like diffusion tensor imaging and functional MRI
44 Adults Randomized, parallel, double masking United Kingdom
NCT 03662750 (20) Brain immune cell markers (TSPO) PET as a measure of post-stroke brain inflammation: a natural history imaging cohort Acute ischemic stroke of moderate severity, inflammatory response PET scan with radiotracers attach to brain immune cell markers (TSPO) and light up inflamed areas in brain versus MRI with gadolinium contrast • PET-derived measures of TSPO radiotracer to track the extent and location of inflammation in the brain after stroke and peri-infarct areas (thalamus, hippocampi, amygdalae, midbrain) at day 90 (compared with day 15)
• To explore whether the most inflamed areas in brain undergo the most post-stroke damage correspond to neurological and cognitive deficits (via measure blood inflammatory markers and genetic test for TSPO marker)
25 adults including older adults Prospective cohort study, single masking, open-label United Kingdom
VC21DIDS0085 Yoon et al. (21) The electric simulation and proper positioning for mribased transcranial direct current stimulation in stroke Hemiplegic chronic stroke PET, functional MRI, and diffusion tensor imaging with optimized electrode placement and electrical parameters versus (placebo) or standard rehabilitation therapy • Improvement in motor function of the affected limb, measured by standardized motor function scales such as the Fugl-Meyer Assessment or the Motor Assessment Scale
• PET imaging to quantify changes in regional cerebral blood flow and glucose metabolism and functional MRI to map changes in brain activation patterns during motor tasks, and diffusion tensor imaging to evaluate changes in white matter integrity and neural connectivity
21 Adults Randomized, parallel, double masking Korea
NCT 03584425 (22) Imaging laterality in chronic stroke patients Chronic stroke with motor cortex lesion Rasch modified version of fugl-meyer motor assessment, anatomical image acquisition, functional MRI task and acquisition • Determine the neurobiological quantify a relationship between neural activity and motor performance compare glutamate/gamma-aminobutyric acid (GABA) ratio within contralesionally primary motor cortex using spectroscopy is higher in stroke patients than controls
• Furthermore, in healthy controls prepulse inhibition will positively correlate with GABA/glutamate concentration
44 adults including older adults Phase I, randomized, parallel masking United States
Wu et al. (23) Characterizing physiological heterogeneity of infarction risk in acute ischaemic stroke using MRI Acute ischemic stroke Diffusion-weighted and perfusion-weighted MRI were combined using a generalized linear model • Assessment of physiological heterogeneity in infarction risk
• Evaluation of blood flow and metabolic status on the variability of infarction risk within individual patients and improvement in personalized treatment strategies.
38 adults Randomized, parallel, double masking Denmark Germany
NCT 02452216 (24) Using ferumoxytol-enhanced MRI to measure inflammation in patients with brain tumors or other conditions of the central nervous system Ischemic and haemorrhagic stroke, brain injury, degenerative disorder, infectious disorder, vascular malformation, brain neoplasm Ferumoxytol uptake with relaxation time (T2) MRI • Measurements of iron concentration (indicative of ferumoxytol-enhanced) on T2 weighted MRI on day 1
• Determine number of inflammatory cells (macrophages) in resected biopsy sample at histopathology on days 2–4 for diagnostic, prognostic, and monitor of treatment response of current and future immunotherapies
10 Children, adults including older adults Phase I, single masking, open-label United States
Atchaneeyasakul et al. (25) Intra-arterial ALD401 cell therapy is associated with reduction in stroke volume at 90 days in a subset of the RECOVER-stroke trial Ischemic stroke Intra-arterial administration of ALD401 cell therapy versus control group receiving standard care or a placebo • The reduction in stroke volume, assessed at 90 days post-treatment.
• Improve neurological functional recovery, recording any adverse events associated with intra-arterial administration of ALD401 cell therapy
11 adults Phase III, randomized, parallel, double masking United States
NCT 02809651(26) Confounding factors in the detection of intracranial haemorrhage with the infrascanner Ischemic stroke, intracranial hemorrhage, brain tumor, brain surgery after headache or head trauma Infrascanner compared result of CT scan • Utility determination of the positive and negative predictive value of the infrascanner for detecting of intracranial hemorrhage within 5 minutes
• Delay of in hospital times, time from door to groin puncture (8 hours), rate of dramatic improvement, good functional outcome, and patients treated by endovascular treatment, modified ranking scale score
89 Children, adults including older adults Randomized, parallel, triple masking Belgium
Torres et al. (27) NCT 02405845 Prospective evaluation of carotid free-floating thrombus Stroke, TIA CT angiogram visual marker to distinguish unstable free-floating plaque from stable plaque • Length of intraluminal filling defect on CT angiogram as a measure to distinguish between unstable free-floating thrombi from stable ulcerated plaque with 12 months follow up with clinician treatment strategies used to manage with antithrombotic treatment within 18 months 100 Children, adults including older adults Single masking, open-label Canada
Xu et al. (28) Observation of the clinical effects of danhong injections combined with pitavastatin on blood lipid regulation in patients with ischemic strokes complicated with lipid abnormalities Ischemic stroke complicated with lipid abnormalities danhong injections combined with pitavastatin versus standard care using MRI and CT scans • Clinical measurements of lipid levels, neurological function
• MRI or CT scans to assess brain structure and ischemic damage
• Carotid ultrasound to observe changes in carotid artery plaque and blood flow
116 Adults including older adults Randomized, parallel, double masking China
Featherstone et al. (29) ISRCTN 25337470 Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): a randomised controlled trial with cost-effectiveness analysis Symptomatic atheromatous carotid artery stenosis Carotid artery stenting versus carotid endarterectomy • The incidence of any stroke or death within 30 days post-procedure
• Incidence of disabling stroke, myocardial infarction, stroke or death in the initial 30-day period
• Evaluated using MRI or CT scans to detect new or worsening ischemic lesions in the brain, indicating the occurrence of stroke or transient ischemic attacks
1713 Adults Randomized, parallel, double masking Worldwide
Skjetne et al. (30) NCT 02992821 Pocket sized carotid stenosis screening by junior doctors Stroke, TIA, apoplexy Bed-side pocket-size ultrasound (high frame rate tracking doppler) versus conventional pulsed wave doppler CT angiography for grades carotid stenosis • Determine feasibility and reliability of bed-side ultrasound examinations accuracy of semi quantitative classification (non-significant atherosclerosis versus significant stenosis of carotid arteries) compared with reference imaging methods
• Participants will be followed for a duration of hospital stay, an expected average of approximately within 4 days
75 adults including older adults Single masking, open-label Norway
NCT 00574457 (31) Improving cardiovascular risk prediction use handheld carotid ultrasonography study Atherosclerosis stroke Carotid ultrasound • To determine if non-sonographer health care professionals working in a community medical office practice setting can be trained to detect and evaluate subclinical atherosclerosis, reduce interventions and patient motivation to adhere to therapeutic recommendations within 2 years 355 adults including older adults Phase IV, parallel masking United States