Abstract Background and aims Rapid exclusion of intracranial hemorrhage is critical in acute stroke care. Whether syngo DynaCT Sine Spin non-contrast flat detector CT (FDCT) is sufficient to rule out intracranial hemorrhage compared with conventional multidetector CT (MDCT) remains unknown. Methods SPINNERS is a multicenter, international, prospective, cross-sectional, endpoint assessor–blinded, non-inferiority trial. Patients presenting within 24 hours of last seen well with severe stroke symptoms (NIHSS 7) or symptoms suggestive of intracranial hemorrhage were eligible. MDCT and FDCT were performed within a maximum interval of 4 hours without intervening invasive procedures. The primary endpoint was presence of intracranial hemorrhage (yes/no). Sensitivity and specificity of FDCT were calculated using MDCT as ground truth. FDCT images were independently rated by six blinded readers in a core laboratory. Non-inferiority was predefined as the lower bound of the 95% confidence interval for sensitivity and specificity exceeding 95%. Results Between October 2022 and November 2024, 252 patients were enrolled across 13 centers in Europe and the United States (126 female; 126 ischemic stroke, 126 hemorrhagic stroke, including 14 isolated infratentorial hemorrhages). Median age was 73 years (IQR 61–81.5), and median NIHSS at admission was 13 (IQR 7–18). Final analyses of diagnostic performance are ongoing and will be presented at ESOC 2026. Conclusions SPINNERS will inform physicians whether non-contrast FDCT is sufficient for excluding intracranial hemorrhage in patients with suspected severe acute stroke. ClinicalTrials.gov Identifier: NCT05458908 Conflict of interest
Psychogios et al. (Fri,) studied this question.