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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to investigate the use of DECT (Dual-Energy Computed Tomography) in patients with acute ischemic stroke who receive an intervention (thrombolysis or thrombectomy). The main questions to answer are: 1. Can DECT more accurately differentiate hyperdensities as intracranial haemorrhage (ICH) or contrast extravasation compared with single-energy CT (SECT)?. 2. Will DECT lead to better care for patients with AIS who receive intervention and have post-procedural hyperdensities? Patients who receive intervention for acute ischemic stroke (AIS) receive a SECT at 24 hours as standard of care to determine if ICH is present. In the current study, a DECT will be done in addition to the SECT. Followup imaging (SECT or MRI) will be done at 72 hours to determine if the hyperdensity was indeed ICH. The accuracy of DECT for differentiating ICH from contrast extravasation will be compared.

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 data supports the effectiveness of the treatment Dual Energy CT for stroke?

Dual Energy CT (DECT) is effective in stroke management as it helps distinguish between different types of brain tissue changes, such as differentiating between bleeding and other changes after stroke treatment. It also improves the visualization of early stroke signs and helps predict whether certain areas will become damaged or bleed. ^{1 2 3 4 5}

Is Dual Energy CT (DECT) safe for use in humans?

Dual Energy CT (DECT) is generally considered safe and can potentially reduce radiation exposure compared to traditional CT methods, as it may eliminate the need for additional imaging phases. ^{1 3 6 7 8}

How is the treatment DECT for stroke different from other treatments?

Dual Energy CT (DECT) is unique because it uses two different energy levels to create detailed images, which can help distinguish between different types of tissues and materials in the body. This can provide more information than traditional CT scans, potentially improving the diagnosis and treatment of strokes by better identifying affected areas. ^{1 7 9 10 11}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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]

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 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]

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]

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]

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]

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]

References

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

Can virtual non-contrast imaging replace true non-contrast imaging in multiphase scanning of the neck region? [2023]

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

Principles and Clinical Application of Dual-energy Computed Tomography in the Evaluation of Cerebrovascular Disease. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

Dual-energy computed tomography in acute ischemic stroke: state-of-the-art. [2021]

4. Denmark pubmed.ncbi.nlm.nih.gov

[Dual-energy CT]. [2021]

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

Unenhanced Dual-Energy Computed Tomography: Visualization of Brain Edema. [2018]

6. Germany 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. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Split-filter dual energy computed tomography radiotherapy: From calibration to image guidance. [2023]

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

Optimization of kiloelectron volt settings in cerebral and cervical dual-energy CT angiography determined with virtual monoenergetic imaging. [2016]

9. England pubmed.ncbi.nlm.nih.gov

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

10. Ireland pubmed.ncbi.nlm.nih.gov

Soft tissue discrimination ex vivo by dual energy computed tomography. [2016]

11. Poland pubmed.ncbi.nlm.nih.gov

In vitro analysis of urinary stone composition in dual-energy computed tomography. [2022]