15 Participants NeededMy employer runs this trial

Prototype CT Scan for Stroke

(ICH-CTP II Trial)

ES
SE
Overseen BySydney Edwards
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Icahn School of Medicine at Mount Sinai
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test two CT scan prototypes, DynaCT Multiphase and DynaCT Sine Spin, to determine if they improve stroke detection and treatment. Researchers will gather CT scans before and after a procedure to assess whether these new tools facilitate spotting brain bleeding and aid in treatment. The trial targets patients scheduled for a minimally invasive procedure to remove brain hemorrhage at Mount Sinai West Hospital. As an unphased trial, it offers patients the chance to contribute to pioneering research that could enhance stroke detection and treatment.

Do I need to stop my current medications for the trial?

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

What prior data suggests that these CT scan prototypes are safe for stroke evaluation?

Previous studies have shown that the DynaCT Multiphase and DynaCT Sine Spin are safe. Research indicates that the DynaCT Multiphase aids doctors in making better treatment decisions by using 3D images to visualize blood vessels during procedures, potentially reducing the need for additional surgeries. The technology is patient-friendly and non-invasive, which lowers risks.

For DynaCT Sine Spin, studies have demonstrated its accuracy in detecting brain bleeding in stroke patients. This capability allows doctors to see crucial details without resorting to risky procedures. Reports confirm that it provides high-quality images with low radiation, ensuring patient safety.

Both technologies have been used in medical settings and have consistently shown safety for patients undergoing these scans. This suggests they are generally well-tolerated, with no major side effects reported.12345

Why are researchers excited about this trial?

Unlike traditional CT scans for stroke, which typically provide a single snapshot of blood flow in the brain, the DynaCT Multiphase scan captures multiple images over time. This dynamic imaging can offer a more detailed view of how blood is moving in real-time, potentially leading to faster and more accurate diagnosis of strokes. Researchers are excited about this innovation because it could significantly improve the speed and precision of stroke assessments, making it easier to decide on the best treatment path for patients quickly.

What evidence suggests that these CT scan prototypes are effective for stroke evaluation?

This trial will compare the DynaCT Multiphase scan and the DynaCT Sine Spin scan. Research has shown that the DynaCT Multiphase scan aids in stroke treatment by helping doctors make better decisions through detailed imaging of blood flow in the brain. Studies have found that patients with clearer images of alternative blood flow paths using this scan tend to recover better. In contrast, the DynaCT Sine Spin scan enhances image quality, particularly in critical brain areas. It accurately detects different types of brain bleeds, with a success rate of up to 84.2% for identifying those with the condition and up to 97.3% for those without it. Both scans aim to improve decision-making during emergency stroke situations.23678

Who Is on the Research Team?

CK

Christopher Kellner

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for adults (18 or older) who are scheduled to have minimally invasive surgery to remove bleeding in the brain (ICH) at Mount Sinai West Hospital.

Inclusion Criteria

I am 18 years old or older.
I am scheduled for minimally invasive hemorrhage evacuation at Mount Sinai West.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-procedural Assessment

Collection of pre-procedural CT scans to evaluate Siemens prototypes

1 week
1 visit (in-person)

Intra-procedural Assessment

Intra-procedural post-evacuation scans using DynaCT Sine Spin and DynaCT Multiphase

Immediate
1 visit (in-person)

Immediate Post-procedural Assessment

Immediate post-procedural CT scans to evaluate Siemens prototypes

Immediate
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • DynaCT Multiphase
  • DynaCT Sine Spin

Trial Overview

The study is testing two new types of CT scan technology—one that measures blood flow and another that automatically detects brain bleeds—to see how useful they are during and after ICH removal procedures.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: DynaCT Multiphase scanExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials
933
Recruited
579,000+

Siemens Corporation, Corporate Technology

Industry Sponsor

Trials
23
Recruited
9,400+

Citations

Dynamic CT but Not Optimized Multiphase CT Angiography ...

This study introduced dynamic CTA and optimized multiphase CTA, and dCTA showed improved reliability on the assessment of collaterals compared to omCTA. We ...

iSchemaView Launches Rapid ANGIO

The syngo DynaCT Multiphase is a state-of-the-art 3-dimensional image acquisition technique employing multiple rotations of a C-arm system to ...

Advanced stroke management and patient care

syngo DynaCT Sine Spin improves the image quality of cranial Flat-Detector CT (FDCT) scans, especially in the posterior fossa and the basal part of the skull.

Prediction of tissue outcome in acute ischemic stroke ...

The aim of this work was to develop a deep learning model that can predict the follow-up infarct location and extent exclusively based on acute single-phase ...

ARTIS icono - A breakthrough in neuro interventions

By making collateral status imaging an integral part of your interventional suite, syngo DynaCT Multiphase supports sound treatment decisions before mechanical.

syngo DynaCT

syngo DynaCT allows for verifying treatment success while the patient is still on the table, reducing the need for re-interventions and re-operations.

10278 AT MSC Study Protocols Booklet iPDF

3D imaging helps to determine the optimal angle of the C-arm for intraprocedural fluoroscopy, ensuring safe deployment of stent and coil placement. 28. 29.

ARTIS icono for neuro interventions

For the first time, syngo DynaCT Multiphase makes it possible to assess the collateral vessels with time-resolved syngo DynaCT, depicting 10 different time ...