DECT for Stroke

(DECT-ICH Trial)

Overseen By Jai Shankar, MD, DM, MSc.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Must not be taking: Thrombin inhibitors, Factor Xa inhibitors

Disqualifiers: Intracerebral hemorrhage, Coagulopathy, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Dual-Energy CT, a special type of CT scan, can better identify brain bleeding after treatment for acute ischemic stroke. The researchers aim to determine if this advanced imaging can help doctors distinguish between actual bleeding and other changes that appear similar on standard scans. People who have had a stroke and received treatments like clot-busting drugs (thrombolysis) or a procedure to remove a clot (thrombectomy) might be suitable candidates. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could enhance stroke care for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on certain blood thinners or have specific medical conditions, you might not be eligible for the trial.

What prior data suggests that DECT is safe for patients with acute ischemic stroke?

Research has shown that Dual-Energy CT (DECT) is generally safe for patients. In past studies, DECT helped doctors diagnose conditions like reduced blood flow (ischemia) and brain bleeding more accurately. Importantly, these studies did not find any major safety issues or negative effects from using DECT.

DECT provides clearer images of different tissue types compared to traditional CT scans, offering more detailed information without adding risk to patients. As an imaging scan, DECT does not use medications that might cause side effects. Overall, DECT is well-tolerated and considered a safe option for improving the diagnosis and treatment of sudden strokes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Dual Energy CT (DECT) for stroke patients because it offers a more detailed imaging technique compared to the traditional single-energy CT scans. Unlike standard CT scans that provide a single type of image, DECT can capture multiple layers of information by using two energy levels. This allows for better differentiation between tissues, which can help in more accurately assessing the brain after a stroke. By potentially providing clearer images of blood clots and damaged areas, DECT could improve the precision of treatments like thrombolysis or endovascular therapy, leading to better patient outcomes.

What evidence suggests that DECT is effective for differentiating ICH from contrast extravasation in acute ischemic stroke?

Research has shown that Dual-Energy Computed Tomography (DECT), which participants in this trial will receive, effectively distinguishes different types of tissues and materials in the brain. This capability helps doctors differentiate between brain bleeding and other substances, such as the dye used in scans. Studies have found that DECT facilitates accurate diagnosis of issues like reduced blood flow and bleeding in stroke patients. It also provides clearer images of the brain after treatments like clot removal. Overall, DECT aids doctors in making quicker and more accurate treatment decisions for stroke patients. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with acute ischemic stroke who are eligible for clot-busting medication or a procedure to remove the clot. It's not suitable for those who don't meet these specific conditions.

Inclusion Criteria

I am 18 or older and a candidate for stroke treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Patients with acute ischemic stroke receive thrombolysis or endovascular thrombectomy

Immediate

1 visit (in-person)

Imaging and Assessment

Dual-energy CT (DECT) and single-energy CT (SECT) are performed to differentiate intracerebral hemorrhage from contrast extravasation

24 hours post-intervention

1 visit (in-person)

Follow-up Imaging

Follow-up imaging (SECT or MRI) is done to confirm the presence of intracerebral hemorrhage

72 hours post-intervention

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Dual Energy CT

Trial Overview The study tests if Dual-Energy Computed Tomography (DECT) can better identify bleeding in the brain or leakage of contrast dye compared to standard CT scans in stroke patients after treatment.

How Is the Trial Designed?

Group I: Dual Energy CT Experimental Treatment 1 Intervention

Patients with acute stroke who receive intervention in the form of thrombolysis or EVT will receive dual-energy CT at the 24-hour mark in lieu of conventional single-energy CT.

Dual Energy CT is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Dual Energy CT for:

• Cardiovascular imaging
• TAVR planning

Approved in United States as Dual Energy CT for:

• Cardiovascular imaging
• TAVR planning

Approved in Canada as Dual Energy CT for:

• Cardiovascular imaging
• TAVR planning

Approved in Japan as Dual Energy CT for:

• Cardiovascular imaging
• TAVR planning

Approved in China as Dual Energy CT for:

• Cardiovascular imaging
• TAVR planning

Approved in Switzerland as Dual Energy CT for:

• Cardiovascular imaging
• TAVR planning

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Published Research Related to This Trial

In a study of 860 children undergoing abdominopelvic exams, dual-energy computed tomography (DECT) was found to deliver lower radiation doses compared to conventional single-energy CT (SECT), with significant reductions in both size-specific dose estimates (SSDE) and volume CT dose index (CTDIvol).

The image quality of DECT was comparable to that of SECT across different patient sizes, indicating that DECT can be a safer alternative without compromising diagnostic quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of radiation dose and image quality between contrast-enhanced single- and dual-energy abdominopelvic computed tomography in children as a function of patient size. Siegel, MJ., Mhlanga, JC., Salter, A., et al.[2021]

Dual-energy computed tomography (DECT) offers promising advantages over single-energy CT (SECT) in radiotherapy, providing various image reconstructions that enhance tumor delineation and calibration accuracy, as demonstrated in a study involving 10 cancer patients.

The study found that DECT's virtual monoenergetic images (VMIs) improved tumor delineation accuracy and showed dosimetric agreement with SECT, suggesting DECT could be a viable alternative in the radiotherapy workflow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Split-filter dual energy computed tomography radiotherapy: From calibration to image guidance. Edmund, J., Feen Rønjom, M., van Overeem Felter, M., et al.[2023]

The proposed material decomposition algorithm for Dual-Energy CT (DECT) effectively separates blood and fat regions of interest with errors of less than 2% and 9%, respectively, demonstrating high precision in clinical imaging.

This new algorithm achieves up to 97.1% accuracy in decomposing materials like iodine contrast agents, improving the workflow of material decomposition and offering a semi-automatic approach that enhances existing methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantification of contrast agent materials using a new image- domain multi material decomposition algorithm based on dual energy CT. Mirzaei, F., Faghihi, R.[2022]

In a study involving 100 patients with primary hyperparathyroidism, virtual non-contrast (VNC) images from dual-energy computed tomography (DECT) showed good agreement with true non-contrast (TNC) images for most neck anatomical structures, potentially reducing radiation exposure.

However, significant differences in CT density were observed in the thyroid gland, indicating that VNC images cannot fully replace TNC images when specifically examining the thyroid and surrounding tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can virtual non-contrast imaging replace true non-contrast imaging in multiphase scanning of the neck region? Al-Difaie, Z., Scheepers, MH., Bouvy, ND., et al.[2023]

Dual-energy computed tomography (DECT) can effectively differentiate between hemorrhage and contrast staining in patients after endovascular stroke therapy, which is crucial for accurate diagnosis and management.

DECT enhances the visualization of early infarctions and can predict changes in contrast-enhancing areas, potentially improving treatment decisions for ischemic stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual-energy computed tomography in acute ischemic stroke: state-of-the-art. Mangesius, S., Janjic, T., Steiger, R., et al.[2021]

Dual-energy computed tomography (DECT) offers advanced imaging capabilities by using two X-ray energy levels, allowing for better analysis of cerebrovascular diseases through techniques like virtual noncontrast and iodine overlay images.

DECT enhances the identification and differentiation of various cerebrovascular conditions, such as detecting active bleeding in intracranial hemorrhages and improving the assessment of atheromatous plaques, which can lead to more accurate diagnoses and treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Principles and Clinical Application of Dual-energy Computed Tomography in the Evaluation of Cerebrovascular Disease. Hsu, CC., Kwan, GN., Singh, D., et al.[2020]

In a study of 41 patients undergoing dual-energy computed tomography (DECT) angiography, 60-keV monoenergetic images significantly improved vessel attenuation and contrast-to-noise ratio (CNR) for both cervical and cerebral angiography compared to standard 120-kV polyenergetic images.

The improvements in image quality suggest that using 60-keV monoenergetic data sets could enhance diagnostic capabilities in DECT angiography, although further research is needed to determine if this technique can also reduce the required dose of iodinated contrast material.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimization of kiloelectron volt settings in cerebral and cervical dual-energy CT angiography determined with virtual monoenergetic imaging. Schneider, D., Apfaltrer, P., Sudarski, S., et al.[2016]

Using Dual Energy Computed Tomography (DECT) with two energy levels (80 and 140 kV) significantly enhances the ability to differentiate between various soft tissue components in arterial plaques, as shown in an in vitro study with multiple tissue samples.

The study found that DECT improved classification accuracy for different types of thrombus and muscle tissues, indicating its potential for better diagnosis, although further research is needed to confirm these benefits in live patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soft tissue discrimination ex vivo by dual energy computed tomography. Zachrisson, H., Engström, E., Engvall, J., et al.[2016]

Dual energy computed tomography (DECT) can effectively differentiate between uric acid and calcium urinary stones, which is important for selecting the right treatment, as shown in a study of 6 surgically removed renal stone samples.

However, DECT was unable to accurately distinguish between different types of calcium stones (calcium phosphate vs. calcium oxalate) and faced limitations in identifying mixed composition stones, indicating a need for further refinement in this imaging technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro analysis of urinary stone composition in dual-energy computed tomography. Stępień, M., Chrzan, R., Gawlas, W.[2022]

Dual-energy CT (DECT) is a promising imaging technique that allows for the differentiation and quantification of materials based on their atomic composition, enhancing diagnostic capabilities across various organ systems.

Despite its potential benefits in clinical applications, DECT is not widely used yet, primarily due to a lack of familiarity and the need for a new workflow among radiologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dual-energy CT]. Xu, JJ., Hansen, KL., Lönn, L., et al.[2021]

Dual-energy computed tomography (DECT) imaging significantly outperforms conventional noncontrast CT in detecting brain edema and predicting end-infarct volume in patients with acute ischemic stroke, with a sensitivity of 93.33% and specificity of 100%.

In a study of 40 patients presenting within 4 hours of stroke symptoms, DECT provided a more accurate assessment of infarction extent compared to standard imaging, which may improve treatment decisions and patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unenhanced Dual-Energy Computed Tomography: Visualization of Brain Edema. Mohammed, MF., Marais, O., Min, A., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8128835/

Dual-energy computed tomography in acute ischemic stroke Dual-energy computed tomography (DECT) allows distinguishing between tissues with similar X-ray attenuation but different atomic numbers.

2. ahajournals.org ahajournals.org/doi/10.1161/SVIN.123.001193

Clinical Applications of Dual‐Energy Computed ... Dual‐energy computed tomography is a powerful tool that can be used to improve the diagnostic accuracy of ischemia, hemorrhage, and vascular lesions in the ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2405844023107481

Dual-energy computed tomography angiography-based ... Our findings showed that DECT angiography-based quantification of NWU helps identify the stroke patients within 4.5 h with high predictive efficiency.

4. clinicalimagingscience.org clinicalimagingscience.org/efficacy-of-dual-layer-spectral-detector-computed-tomography-for-detecting-early-ischemic-changes-in-patients-with-acute-ischemic-stroke-a-pilot-study/

Efficacy of dual-layer spectral detector computed ... This study evaluated the efficacy of dual-layer spectral detector computed tomography (DLCT) for detecting early ischemic changes (EICs) in patients with acute ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10450017/

Dual-Energy Computed Tomography in Stroke Imaging TwinSpiral DECT allows an improved qualitative and quantitative visualization of ischemic brain tissue in ischemic stroke patients after endovascular treatment.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7249255/

Dual-Energy CT Follow-Up After Stroke Thrombolysis ... Background and Purpose: We aimed to determine whether dual-energy CT (DECT) follow-up can differentiate contrast staining (CS) from intracranial hemorrhage (ICH) ...