Imaging Techniques for Intracranial Hemorrhage

(SPINNERS Trial)

Recruiting at 14 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging method, the non-contrast syngo DynaCT Sine Spin head scan and application software, to determine its accuracy in detecting brain bleeding after a stroke. The goal is to assess whether this new scan matches the reliability of the current standard, the non-contrast cranial MDCT head scan. Success could expedite stroke treatment by integrating imaging and therapy into one process. The trial seeks participants who have experienced stroke symptoms and can undergo two scans within four hours, with no planned medical procedures between scans. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance stroke treatment.

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 prior data suggests that these imaging techniques are safe for detecting intracranial hemorrhage?

Research is investigating whether the non-contrast syngo DynaCT Sine Spin head scan matches the effectiveness of traditional CT scans in detecting brain bleeding. This scan has undergone testing on people before, indicating its general safety. In other studies, patients have experienced similar scans without major issues. As an imaging test, it does not involve drugs or surgery, which typically enhances its safety. While solid data on negative side effects is not yet available, the nature of the test suggests it is likely to be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new imaging technique for diagnosing intracranial hemorrhage. Unlike standard CT scans, the syngo DynaCT Sine Spin head scan offers a potentially faster and more detailed look at the brain without the need for contrast agents. This could mean quicker diagnosis and treatment for patients showing symptoms of a stroke. The technique's ability to work within a short timespan between scans also minimizes delays, which is crucial in emergency situations.

What evidence suggests that non-contrast syngo DynaCT Sine Spin imaging is effective for detecting intracranial hemorrhages?

Research has shown that non-contrast syngo DynaCT Sine Spin imaging might be as effective as standard CT scans for detecting brain bleeds. In this trial, participants will undergo both a non-contrast MDCT scan and a non-contrast syngo DynaCT Sine Spin head scan. Studies suggest that syngo DynaCT Sine Spin imaging can help distinguish between different types of strokes, which is crucial for selecting the right treatment. Early tests indicated that this new method can quickly and reliably detect bleeding inside the skull. This could speed up stroke diagnosis and lead to faster treatment. However, it is still being tested to ensure accuracy comparable to current methods. ^{1 2 3 4 5}

Who Is on the Research Team?

Nitin Goyal, MD

Principal Investigator

Semmes Murphey Clinic and University of Tennessee Health Sciences Center

Marios-Nikos Psychogios, Prof Dr

Principal Investigator

University Hospital, Basel, Switzerland

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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 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 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]

Citations

1. jnis.bmj.com jnis.bmj.com/content/15/3/292

Evaluation of Sine Spin flat detector CT imaging compared ... This study compared the effective dose, image quality and diagnostic performance of the latest generation of SFDCT with multidetector CT (MDCT).

2. clinicaltrial.be clinicaltrial.be/en/details/16049?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

ProSPective Evaluation of Non-contrast sINe spiN Flat-dEt... The primary outcome will be used to calculate the sensitivity and specificity of non-contrast syngo DynaCT Sine Spin imaging for the detection ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05458908

ProSPective Evaluation of Non-contrast sINe spiN Flat- ... 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12393753/

PMC Search Update - PubMed Central - NIH This trial will inform physicians whether syngo DynaCT Sine Spin non-contrast FDCT imaging can reliably exclude intracranial hemorrhages in ...

5. mountsinai.org mountsinai.org/clinical-trials/prospective-evaluation-of-non-contrast-sine-spin-flat-detector-ct-for-detection-of-intracranial-hemorrhages

ProSPective Evaluation of Non-contrast sINe spiN Flat- ... ... 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 ...