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
Year: 2025
Type: article
Study design: Study Protocol
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. TRIAL REGISTRATION: ClinicalTrials.gov NCT05458908.
Source: PLoS ONE
Authors: Marios Psychogios, Alex Brehm, Nitin Goyal, Grégoire Boulouis, Jan-Karl Burkhardt, Shakeel A. Chowdhry, Donald Frei, Jan Gralla, Johannes Kaesmacher, Ryan T. Kellogg, Christopher P. Kellner, Demetrius K. Lopes, Eytan Raz, Daniel Strbian, Laura Mannismäki, Alejandro Tomasello, Ioannis Tsogkas, Alexander von Hessling, Grzegorz M. Karwacki, Raphael Guzman, Nikki Rommers, David S. Liebeskind, Adam S. Arthur, on behalf of the SPINNERS investigators
Institutions: University Hospital of Basel, University of Tennessee Health Science Center, Centre Hospitalier Universitaire de Tours, Hospital of the University of Pennsylvania, University of Pennsylvania, Endeavor Health, University Hospital of Bern, University of Virginia, Mount Sinai Health System, Mount Sinai Hospital, NYU Langone Health, New York University, University of Helsinki, Helsinki University Hospital, Vall d'Hebron Hospital Universitari, Luzerner Kantonsspital, University of California, Los Angeles
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,382
OpenAlex ID: W4413805060