ProSPective evaluation of the dIagnostic accuracy of siNe spiN non-contrast flatdEtectoR CT (FDCT) for the detection of intracranial hemorrhage in stroke patients - Protocol of a non-inferiority comparison to multi detector CT
Authors
Marios Psychogios, Department of Diagnostic and Interventional Neuroradiology, University Hospital Basel, Basel, Switzerland.
Alex Brehm, Department of Diagnostic and Interventional Neuroradiology, University Hospital Basel, Basel, Switzerland.
Nitin Goyal, Department of Neurosurgery, Semmes Murphey Clinic and University of Tennessee Health Sciences Center, Memphis, Tennessee, United States of America.
Grégoire Boulouis, Service de Neuroradiologie, CHRU Tours, Tours, France.
Jan-Karl Burkhardt, Department of Cerebrovascular Surgery, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States of America.
Shakeel A. Chowdhry, Department of Neurosurgery, Endeavor Health, Chicago, Illinois, United States of America.
Donald Frei, RIA Neurovascular, Englewood, Colorado, United States of America.
Jan Gralla, Department of Neuroradiology, Inselspital Bern, Bern, Switzerland.
Johannes Kaesmacher, Service de Neuroradiologie, CHRU Tours, Tours, France.
Ryan T. Kellogg, Department of Neurosurgery, University of Virginia, Charlottesville, Virginia, United States of America.
Christopher P. Kellner, Department of Neurosurgery, Mt Sinai Hospital Systems, New York, New York, United States of America.
Demetrius K. Lopes, Advocate Health - MidwestFollow
Eytan Raz, Department of Neuroradiology, NYU Langone Health, New York, New York, United States of America.
Daniel Strbian, Department of Neurology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Laura Mannismäki, Department of Neurology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Alejandro Tomasello, Department of Neuroradiology, Hospital Vall d'Hebron, Barcelona, Spain.
Ioannis Tsogkas, Department of Diagnostic and Interventional Neuroradiology, University Hospital Basel, Basel, Switzerland.
Alexander von Hessling, Section of Neuroradiology, Radiology and Nuclear Medicine, Cantonal Hospital of Lucerne, Lucerne, Switzerland.
Grzegorz M. Karwacki, Section of Neuroradiology, Radiology and Nuclear Medicine, Cantonal Hospital of Lucerne, Lucerne, Switzerland.
Raphael Guzman, Department of Neurosurgery, University Hospital Basel, Basel, Switzerland.
Nikki Rommers, Department of Clinical Research, University Hospital Basel, Basel, Switzerland.
David S. Liebeskind, Department of Neurology, UC Los Angeles, Los Angeles, California, United States of America.
Adam S. Arthur, Department of Neurosurgery, Semmes Murphey Clinic and University of Tennessee Health Sciences Center, Memphis, Tennessee, United States of America.
Recommended Citation
Psychogios M, Brehm A, Goyal N, et al. ProSPective evaluation of the dIagnostic accuracy of siNe spiN non-contrast flatdEtectoR CT (FDCT) for the detection of intracranial hemorrhage in stroke patients - Protocol of a non-inferiority comparison to multi detector CT. PLoS One. 2025;20(8):e0330608. Published 2025 Aug 28. doi:10.1371/journal.pone.0330608
Abstract
Rationale: Whether syngo DynaCT Sine Spin non-contrast flat detector CT (FDCT) imaging is sufficient to rule out intracranial hemorrhage in suspected acute stroke patients is unknown.
Aim: To determine if syngo DynaCT Sine Spin non-contrast FDCT imaging is non-inferior to conventional multidetector CT (MDCT) imaging for the detection and exclusion of intracranial hemorrhages in suspected acute stroke patients.
Sample size: To enroll 252 participants in three buckets (126 ischemic stroke patients, 126 hemorrhagic stroke patients (including 14 patients with an isolated infratentorial hemorrhage).
Methods and design: A multicenter, international, prospective, cross-sectional, endpoint assessor blinded, non-inferiority trial.
Outcomes: The primary outcome is the occurrence of an intracranial hemorrhage (yes versus no). This will be used to calculate the sensitivity and specificity of FDCT imaging for the detection of intracranial hemorrhages. All FDCT images will be rated by six independent raters in a blinded imaging core-lab. The rating of the MDCT images will be deemed as ground-truth. FDCT imaging will be deemed non-inferior if the lower bound of the 95%-Confidence Interval of the sensitivity and specificity is above 95%.
Discussion: This trial will inform physicians whether syngo DynaCT Sine Spin non-contrast FDCT imaging can reliably exclude intracranial hemorrhages in patients with suspected acute stroke.
