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

Stroke Clinical Trial

— SPINNERS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05458908
• Other study ID #: qu20Psychogios_SPINNERS
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: January 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Marios-Nikos Psychogios, Prof Dr
• Phone: +41 61 328 59 36
• Email: marios.psychogios[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 252
• Est. completion date: July 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed Consent as documented by signature or fulfilling the criteria for emergency or deferral consent

• Patients with symptoms suggestive of ischemic stroke (NIHSS = 7) or suggestive of haemorrhagic stroke with a cranial non-contrast MDCT and a feasible non-contrast syngo DynaCT Sine Spin within 4 hours

• Patient presenting within 24 hours of last seen well

• Patients presenting directly to the treating hospital (i.e. mothership patients) OR transfer patients with the indication for repeated imaging according to the standard operation procedures of the treating hospital

• Age above 18 years

• Agreement of treating physician to perform non-contrast syngo DynaCT Sine Spin

Exclusion Criteria:

• Severe metal artifacts on initial MDCT imaging

• Planned invasive interventions between MDCT and FDCT scan

• Clinical deterioration between MDCT and FDCT scan (i.e. an increase of the NIHSS of more than 4 points)

• Evidence of an ongoing pregnancy prior to enrollment. A negative pregnancy test before enrollment is required for all women with child-bearing potential

Related Conditions & MeSH terms

• Hemorrhage
• Intracranial Hemorrhages
• Stroke

Intervention

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)
• 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.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel
Switzerland	Inselspital Bern	Bern
Switzerland	Kantonsspital Luzern	Luzern
United States	Semmes Murphy Clinic	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Siemens Healthineers AG

Countries where clinical trial is conducted

United States,  Switzerland, 

References & Publications (3)

Leyhe JR, Tsogkas I, Hesse AC, Behme D, Schregel K, Papageorgiou I, Liman J, Knauth M, Psychogios MN. Latest generation of flat detector CT as a peri-interventional diagnostic tool: a comparative study with multidetector CT. J Neurointerv Surg. 2017 Dec;9(12):1253-1257. doi: 10.1136/neurintsurg-2016-012866. Epub 2016 Dec 20. — View Citation

Petroulia VD, Kaesmacher J, Piechowiak EI, Dobrocky T, Pilgram-Pastor SM, Gralla J, Wagner F, Mordasini P. Evaluation of Sine Spin flat detector CT imaging compared with multidetector CT. J Neurointerv Surg. 2023 Mar;15(3):292-297. doi: 10.1136/neurintsurg-2021-018312. Epub 2022 Mar 22. — View Citation

Psychogios MN, Behme D, Schregel K, Tsogkas I, Maier IL, Leyhe JR, Zapf A, Tran J, Bahr M, Liman J, Knauth M. One-Stop Management of Acute Stroke Patients: Minimizing Door-to-Reperfusion Times. Stroke. 2017 Nov;48(11):3152-3155. doi: 10.1161/STROKEAHA.117.018077. Epub 2017 Oct 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Adverse Device Events (ADEs)	All device related adverse events (ADEs) will be evaluated up to 24 hours after the study intervention.	At 24 h ± 6h after enrollment
Primary	Occurrence of an intracranial hemorrhage (yes/no)	The primary outcome is the occurrence of intracranial hemorrhages (yes vs no) as assessed by a blinded core-lab. The primary outcome will be used to calculate the sensitivity and specificity of non-contrast syngo DynaCT Sine Spin imaging for the detection of intracranial hemorrhages.; The primary outcome will be assessed on both scans.	Day 0 - within 4 hours of enrollment