NCT05458908

ProSPective Evaluation of Non-contrast sINe spiN Flat-dEtectoR CT for the Detection of Intracranial hemorrhageS

ProSPective Evaluation of the dIagnostic Accuracy of siNe spiN Noncontrast Flat-dEtectoR CT (FDCT) for the Detection of Intracranial Hemorrhage in Stroke Patients

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 252 (estimated)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Stroke is one of the leading causes of mortality and disability worldwide. Optimization of intra-hospital pathways is as of today one of the most promising research topics in stroke treatment. A potential solution to shorten the time needed for current workflows, and therefore reperfusion, is to do both imaging and subsequent endovascular therapy (EVT) in the angiography suite using non-contrast syngo DynaCT Sine Spin (FDCT) for the exclusion of intracranial hemorrhage and flat detector CT angiography (FDCTA) or digital subtraction angiography for diagnosis of LVO. It is still a matter of debate if FDCT can reliably differentiate between ischemic and hemorrhagic stroke. This study aims to investigate if non-contrast syngo DynaCT Sine Spin imaging is non-inferior to non-contrast MDCT imaging regarding its sensitivity and specificity for the detection of intracranial hemorrhages.

Detailed description

Despite concerted efforts, stroke is still one of the leading causes of mortality and disability worldwide.Stroke can be divided into two main types: ischemic and hemorrhagic stroke. Endovascular therapy (EVT) became the gold-standard for the treatment of acute ischemic stroke due to large-vessel occlusions (LVO). However, as was shown by a post-hoc meta-analysis of five trials clinical outcome is highly associated with the time from hospital admission to treatment. One possibility to substantially shorten this time span is the implementation of a One Stop Management approach. In this workflow both imaging and subsequent EVT is done in the angiography suite using non-contrast flat detector CT (FDCT) for the exclusion of an intracranial hemorrhage. Such workflows dramatically reduce intra-hospital time delays (median reductions of more than 30 minutes) and are associated with improved patient outcomes. One of the biggest hurdles for a large-scale implementation of a One Stop Management approach up to now is the ability to differentiate between ischemic and hemorrhagic stroke with FDCT. In a recent study we have reported very high sensitivity and specificity for the detection of intracranial hemorrhage with FDCT. Recently Siemens Healthineers introduced the new ARTIS icono angiography system with a new non-contrast syngo DynaCT Sine Spin protocol FDCT, which should improve the quality and soft tissue resolution of native cranial FDCT scans especially in the posterior fossa and skull base. Therefore, the study aims to evaluate if non-contrast syngo DynaCT Sine Spin FDCT is non-inferior to non-contrast multidetector CT (MDCT) for the detection of intracranial hemorrhages.

Conditions

• Stroke

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Non-contrast cranial MDCT head scan	Non-contrast cranial MDCT imaging for visualization of the brain parenchyma (the choice of the device is up to the investigator)
DIAGNOSTIC_TEST	Non-contrast syngo DynaCT Sine Spin head scan and application software	Non-contrast syngo DynaCT Sine Spin imaging for visualization of the brain parenchyma with ARTIS icono biplane angiography system and syngo application software with syngo DynaCT Sine Spin 3-D head imaging protocol.

Timeline

• Start date: 2022-10-25
• Primary completion: 2025-11-11
• Completion: 2026-03-15
• First posted: 2022-07-14
• Last updated: 2026-03-03

Locations

14 sites across 5 countries: United States, Finland, France, Spain, Switzerland