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

NCT05458908 | Active Not Recruiting DMC

• 1 other identifier: qu20Psychogios_SPINNERS
• Study Type: interventional
• Target: 252
• Locations: 5 countries
• Sites: 14

Brief 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.

Conditions

Stroke

Keywords

hemorrhagic stroke; ischemic stroke; large-vessel occlusions (LVO); cone beam CT; intracranial hemorrhage; flat detector computer tomography (FDCT)

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (1)

• Change in Adverse Device Events (ADEs)

  At 24 h ± 6h after enrollment

Study Arms (1)

Cranial non-contrast syngo DynaCT Sine Spin scan

EXPERIMENTAL

There is only one arm as all patients undergo the same intervention. Subjects with clinical features/symptoms of a stroke (hemorrhagic and non-hemorrhagic stroke patients) will be enrolled. All patients will undergo first a non-contrast MDCT scan and then a non-contrast syngo DynaCT Sine Spin head scan within a maximum timespan of 4 hours between both scans. Only patients in which no invasive procedure in between is planned can be enrolled.

Diagnostic Test: Non-contrast cranial MDCT head scan; Diagnostic Test: Non-contrast syngo DynaCT Sine Spin head scan and application software

Interventions

Non-contrast cranial MDCT head scan DIAGNOSTIC_TEST

Non-contrast cranial MDCT imaging for visualization of the brain parenchyma (the choice of the device is up to the investigator)

Cranial non-contrast syngo DynaCT Sine Spin scan

Non-contrast syngo DynaCT Sine Spin head scan and application software DIAGNOSTIC_TEST

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.

Cranial non-contrast syngo DynaCT Sine Spin scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Siemens Healthineers AG: collaborator

Study Sites (14)

Swedish Medical Center

Denver, Colorado, 80210, United States

Location

AdvocateAurora Health

Chicago, Illinois, 60068, United States

Location

Nortshore University Health System

Chicago, Illinois, 60201, United States

Location

New York University Langone Health

New York, New York, 10016, United States

Location

Mount Sinai Health System

New York, New York, 10029, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Semmes Murphy Clinic

Memphis, Tennessee, 38120, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22903, United States

Location

HUS

Helsinki, 00290, Finland

Location

CHRU de Tours

Tours, 37000, France

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

University Hospital Basel

Basel, Switzerland

Location

Inselspital Bern

Bern, Switzerland

Location

Kantonsspital Luzern

Lucerne, Switzerland

Location

Related Publications (4)

• Psychogios M, Brehm A, Goyal N, Boulouis G, Burkhardt JK, Chowdhry SA, Frei D, Gralla J, Kaesmacher J, Kellogg RT, Kellner CP, Lopes DK, Raz E, Strbian D, Mannismaki L, Tomasello A, Tsogkas I, von Hessling A, Karwacki GM, Guzman R, Rommers N, Liebeskind DS, Arthur AS; SPINNERS investigators. 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 Aug 28;20(8):e0330608. doi: 10.1371/journal.pone.0330608. eCollection 2025.

  PMID: 40875663 BACKGROUND

• 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.

  PMID: 35318960 BACKGROUND

• 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.

  PMID: 29018132 BACKGROUND

• 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.

  PMID: 27998955 BACKGROUND

MeSH Terms

Conditions

Stroke; Hemorrhagic Stroke; Ischemic Stroke; Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marios-Nikos Psychogios, Prof Dr

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

• Nitin Goyal, MD

  Semmes Murphey Clinic and University of Tennessee Health Sciences Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Blinded assessment of outcome events through an independent Core-Lab
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cross-sectional non-inferiority investigation with prospective open label data collection and blinded endpoint assessment

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: July 14, 2022
• Study Start: October 25, 2022
• Primary Completion: November 11, 2025
• Study Completion: March 15, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-03

Locations

FR (1); FI (1); US (8); CH (3); ES (1)