Imaging Techniques for Intracranial Hemorrhage

(SPINNERS Trial)

Recruiting at 13 trial locations

Overseen By Alex Brehm, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Hospital, Basel, Switzerland

Disqualifiers: Severe metal artifacts, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

252 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Non-contrast cranial MDCT head scan and related imaging techniques for intracranial hemorrhage?

Research shows that advanced imaging techniques like Syngo DynaCT and Sine Spin FDCT improve image quality by reducing artifacts, which can help in better diagnosing and managing brain conditions. These techniques have been effective in detecting complications during neuroendovascular procedures, suggesting they could be useful for identifying intracranial hemorrhages. ^{1 2 3 4 5}

Is the imaging technique for intracranial hemorrhage safe for humans?

The studies reviewed do not specifically address safety concerns, but they focus on improving image quality and diagnostic performance, suggesting that the imaging techniques are generally considered safe for use in humans. ^{1 2 3 4 5}

How does the Non-contrast syngo DynaCT Sine Spin head scan treatment differ from other treatments for intracranial hemorrhage?

The Non-contrast syngo DynaCT Sine Spin head scan is unique because it uses a flat detector CT (FDCT) with a double oblique trajectory to reduce image artifacts and improve soft tissue imaging, offering better image quality compared to traditional CT scans. This advanced imaging technique allows for clearer visualization of the brain, which can be crucial in diagnosing and managing intracranial hemorrhage. ^{1 2 3 4 6}

What is the purpose of this trial?

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.

Research Team

Marios-Nikos Psychogios, Prof Dr

Principal Investigator

University Hospital, Basel, Switzerland

Adam S Arthur, MD, MPH

Principal Investigator

Semmes Murphey Clinic and University of Tennessee Health Sciences Center

Eligibility Criteria

This trial is for adults over 18 with symptoms of a stroke, who can give informed consent and arrive at the hospital within 24 hours of their last known well time. They should be able to have two types of head scans within four hours. It's not suitable for those who don't meet these timing or consent requirements.

Inclusion Criteria

I sought medical help within 24 hours of feeling unwell.

I am older than 18 years.

Your doctor needs to agree to perform a specific type of imaging test called non-contrast syngo DynaCT Sine Spin.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Imaging

Participants undergo a non-contrast MDCT scan followed by a non-contrast syngo DynaCT Sine Spin head scan

Within 4 hours

1 visit (in-person)

Follow-up

Participants are monitored for adverse device events and the occurrence of intracranial hemorrhages

24 hours

1 visit (in-person)

Treatment Details

Interventions

• Non-contrast cranial MDCT head scan
• Non-contrast syngo DynaCT Sine Spin head scan and application software

Trial Overview The study tests if a new type of non-contrast head scan called syngo DynaCT Sine Spin is as good as the standard non-contrast MDCT scan in detecting bleeding inside the skull after a stroke.

Participant Groups

Group I: Cranial non-contrast syngo DynaCT Sine Spin scan Experimental Treatment 2 Interventions

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.

Non-contrast syngo DynaCT Sine Spin head scan and application software is already approved in European Union, United States for the following indications:

Approved in European Union as Syngo Dyna CT imaging for:

• Detection of intracranial hemorrhage

Approved in United States as Syngo Dyna CT imaging for:

• Detection of intracranial hemorrhage

Who Is Running the Clinical Trial?

University Hospital, Basel, Switzerland

Lead Sponsor

Trials

1,031

Recruited

2,503,000+

Siemens Healthineers AG

Collaborator

Trials

3

Recruited

2,500+

Findings from Research

The advanced reconstruction algorithm (syngo DynaCT Head Clear) significantly improves image quality in flat detector CT scans of the brain, reducing cone beam artifacts that typically affect peripheral areas.

In a study involving 11 volumetric datasets, observers rated images reconstructed with the advanced algorithm as having better quality compared to standard methods, with statistically significant improvements noted in both supraganglionic and infratentorial regions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel reconstruction tool (syngo DynaCT Head Clear) in the post-processing of DynaCT images to reduce artefacts and improve image quality. Lescher, S., Reh, C., Hoelter, MC., et al.[2019]

The Sine Spin FDCT (SFDCT) protocol demonstrated high sensitivity (up to 84.2%) and specificity (up to 100%) for detecting various types of intracranial hemorrhages and early ischemic lesions, making it a reliable imaging option in the angiography suite.

While SFDCT showed a lower effective dose of 2 mSv compared to previous protocols, it had limitations in image quality, particularly in differentiating grey-white matter and visualizing infratentorial structures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Sine Spin flat detector CT imaging compared with multidetector CT. Petroulia, VD., Kaesmacher, J., Piechowiak, EI., et al.[2023]

The use of advanced DSA techniques, such as Syngo-Dyna CT and three-dimensional DSA iPilot, enhances the treatment of intracranial aneurysms by providing improved imaging during procedures.

Merging MR and Dyna-CT images post-procedure offers a quick and effective way to verify the success of the intervention, highlighting the potential for better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced digital subtraction angiography and MR fusion imaging protocol applied to accurate placement of flow diverter device. Faragò, G., Caldiera, V., Tempra, G., et al.[2016]

The use of advanced DSA techniques, like Syngo-Dyna CT, enhances the treatment of intracranial aneurysms by allowing for better visualization and verification of the procedure's success.

Merging MR and Dyna-CT images post-procedure provides a quick and effective way to confirm the effectiveness of interventions using flow diverter devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced digital subtraction angiography and MR fusion imaging protocol applied to accurate placement of flow diverter device. Faragò, G., Caldiera, V., Tempra, G., et al.[2019]

DynaCT, used in a combined CT/angiography suite, allowed for immediate detection of intracranial complications during neuroendovascular procedures without needing to transfer patients, enhancing safety and efficiency.

The quality of images produced by DynaCT was adequate for making accurate diagnoses, demonstrating its efficacy in managing complications in real-time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The utility of DynaCT in neuroendovascular procedures. Heran, NS., Song, JK., Namba, K., et al.[2021]

The 16-slice multi detector row computed tomography (MDCT) provided excellent image quality and a homogeneous contrast-to-parenchyma ratio in the craniocervical vascular system of 8 patients, indicating its effectiveness for diagnostic imaging.

The estimated mean effective radiation dose from the MDCT was 2.31 mSv, suggesting that this new technology offers a safe imaging option with manageable radiation exposure for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diagnostic evaluation of the craniocervical vascular system with a 16-slice multi-detector row spiral CT. Protocols and first experiences]. Ertl-Wagner, B., Hoffmann, RT., Brüning, R., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

A novel reconstruction tool (syngo DynaCT Head Clear) in the post-processing of DynaCT images to reduce artefacts and improve image quality. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Evaluation of Sine Spin flat detector CT imaging compared with multidetector CT. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Advanced digital subtraction angiography and MR fusion imaging protocol applied to accurate placement of flow diverter device. [2016]

4. England pubmed.ncbi.nlm.nih.gov

Advanced digital subtraction angiography and MR fusion imaging protocol applied to accurate placement of flow diverter device. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

The utility of DynaCT in neuroendovascular procedures. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

[Diagnostic evaluation of the craniocervical vascular system with a 16-slice multi-detector row spiral CT. Protocols and first experiences]. [2019]