StrokeSPINNERSNCT05458908
ProSPective Evaluation of Non-contrast sINe spiN Flat-dEtectoR CT for the Detection of Intracranial hemorrhageS
A study testing Non-contrast cranial MDCT head scan and Non-contrast syngo DynaCT Sine Spin head scan and application software in people with Stroke, run by University Hospital, Basel, Switzerland at 14 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Non-contrast cranial MDCT head scan and Non-contrast syngo DynaCT Sine Spin head scan and application software
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 14 sitesin 5 countries
- Study dates
- 25 Oct 2022to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 5 countries.
14 sites in 5 countries
United States8 sites
University of Virginia Health System
Charlottesville, Virginia, 22903
AdvocateAurora Health
Chicago, Illinois, 60068
Nortshore University Health System
Chicago, Illinois, 60201
Swedish Medical Center
Denver, Colorado, 80210
Semmes Murphy Clinic
Memphis, Tennessee, 38120
New York University Langone Health
New York, New York, 10016
Mount Sinai Health System
New York, New York, 10029
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Switzerland3 sites
University Hospital Basel
Basel
Inselspital Bern
Bern
Kantonsspital Luzern
Lucerne
About this study
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
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.
Read the 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
- Being tested
- Non-contrast cranial MDCT head scan, Non-contrast syngo DynaCT Sine Spin head scan and application software
- Keywords
- hemorrhagic stroke, ischemic stroke, large-vessel occlusions (LVO), cone beam CT, intracranial hemorrhage, flat detector computer tomography (FDCT)
- Medical subject headings
- Stroke, Hemorrhagic Stroke, Ischemic Stroke, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-contrast cranial MDCT head scanDiagnostic test
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 softwareDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Non-contrast cranial MDCT head scan; Diagnostic Test: Non-contrast syngo DynaCT Sine Spin head scan and application software |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 - within 4 hours of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start25 Oct 2022
- Primary completion11 Nov 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cross-sectional non-inferiority investigation with prospective open label data collection and blinded endpoint assessment
- Masking
- None (open label)
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Healthineers
- Responsible party
- Sponsor
- Investigators
- Marios-Nikos Psychogios, Prof Dr, Principal investigator, University Hospital, Basel, SwitzerlandNitin Goyal, MD, Study chair, Semmes Murphey Clinic and University of Tennessee Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458908
- Sponsor's protocol ID
- qu20Psychogios_SPINNERS
- Acronym
- SPINNERS
- Status last verified
- May 2026
- First submitted
- 20 Jun 2022
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40875663Petroulia 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.
PubMed 35318960Psychogios 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.
PubMed 29018132Leyhe 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.
PubMed 27998955
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05458908
- Acronym / sponsor ID
- SPINNERS / qu20Psychogios_SPINNERS
- Conditions
- Stroke
- Keywords
- hemorrhagic stroke, ischemic stroke, large-vessel occlusions (LVO), cone beam CT, intracranial hemorrhage, flat detector computer tomography (FDCT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Siemens Healthineers
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 11 Nov 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cross-sectional non-inferiority investigation with prospective open label data collection and blinded endpoint assessment
| Arm | Type | Receives |
|---|---|---|
| Cranial non-contrast syngo DynaCT Sine Spin scan | Experimental | Diagnostic Test: Non-contrast cranial MDCT head scan, Diagnostic Test: Non-contrast syngo DynaCT Sine Spin head scan and application softwareThere 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-contrast cranial MDCT head scanNon-contrast cranial MDCT imaging for visualization of the brain parenchyma (the choice of the device is up to the investigator) | Diagnostic test | Cranial non-contrast syngo DynaCT Sine Spin scan |
| Non-contrast syngo DynaCT Sine Spin head scan and application softwareNon-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. | Diagnostic test | Cranial non-contrast syngo DynaCT Sine Spin scan |
Primary outcome
Occurrence of an intracranial hemorrhage (yes/no)
Time frame: Day 0 - within 4 hours of enrollment
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 40875663Psychogios 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.
- Background: PubMed 35318960Petroulia 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.
- Background: PubMed 29018132Psychogios 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.
- Background: PubMed 27998955Leyhe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marios-Nikos Psychogios, Prof Dr principal investigator
University Hospital, Basel, Switzerland
Nitin Goyal, MD study chair
Semmes Murphey Clinic and University of Tennessee Health Sciences Center
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-contrast cranial MDCT head scan and Non-contrast syngo DynaCT Sine Spin head scan and application software in people with Stroke, run by University Hospital, Basel, Switzerland at 14 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Switzerland, Finland, France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of an intracranial hemorrhage (yes/no) (time frame: Day 0 - within 4 hours of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05458908, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.