C-arm Computed Tomography Scan Image Quality in Patients With Neurovascular Diseases

Endovascular Procedures Clinical Trial

Official title:

C-arm Computed Tomography Scan Image Quality in Patients With Neurovascular Diseases: Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03162601
• Other study ID #: TWH-Version 2.0 Sept 28 2016
• Status: Recruiting
• Start date: April 4, 2017
• Est. completion date: November 1, 2019

Study information

• Verified date: October 2018
• Source: University Health Network, Toronto
• Contact: Vitor Pereira, MD
• Phone: (416) 603 5800
• Email: vitor.pereira[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

With new developments that have taken place in the optimization of C-arm computed tomography (CACT) image acquisition and reconstruction, CACT image quality will be better than current standard-of-care CACT scan techniques used for neurovascular patients referred to endovascular treatment or diagnosis. As such, novel acquisition, filtration, artifact reduction and reconstruction techniques will be evaluated against the standard-of-care CACT approach.

Description:

This prospective observational study aims to enroll 50 patients diagnosed with various neurovascular conditions with the goal to compare the image quality of new types of head C-arm computed tomography (CACT) image scans with standard CACT scans, and also to compare these novel scans with standard CT scan image quality. These new scans use novel acquisition, filtration and reconstruction techniques compared to the standard-of-care CACT scans being used in the neuroangiography suite at the present time. Patient selection will be based on a suitability of patients for neuro-endovascular interventions in the neuroangiography suite. All research related activities will be done by study team members. The study patients are expected to follow their routine treatment schedule with the exception of 1 extra CACT scan while patient is receiving their standard treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject is suitable for an endovascular treatment in the neuro-angiography suite.

2. Subject or subject's legally authorized representative has signed an institutionally approved research informed consent form.

3. Subject = 18 years old.

Exclusion Criteria:

1. Subject or subject's legally authorized representative is unable or unwilling to consent to the study.

2. Subject had prior significant or severe allergy to intra-arterial contrast medium uncontrolled by pre-procedure medications.

3. Subject with documented contrast injection contraindication due to severe kidney disease or allergy.

Related Conditions & MeSH terms

• Endovascular Procedures

Intervention

Procedure:
• Neurovascular percutaneous intervention
Patient will receive one extra CACT scan while they are receiving percutaneous neurovascular intervention.

Locations

Country	Name	City	State
Canada	Toronto Western Hospital - University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Philips Healthcare

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with improved new CACT image quality compared to standard CACT based on a 5-point Likert scale	To achieve a brain parenchyma image quality with CACT using novel acquisition, filtration, artifact reduction and reconstruction techniques that is better than current standard-of-care CACT approaches, based on a 5-point Likert scoring scale questionnaire for each patient.	1 year
Secondary	Number of participants with a CACT image quality at the same level or better as standard CT based on a 5-point Likert scale	Achieve CACT image quality equivalent to or better than standard CT scans (if available) in patients with neurovascular diseases or conditions. This comparison will be done based on a 5-point Likert scoring scale questionnaire for each patient.	1 year
Secondary	Number of participants with improved or equivalent contrast-to-noise ratio using new CACT vs. standard CT scans	Contrast-to-noise ratio (unitless quantity) equivalent or higher in new CACT images compared to standard CT images, measured using regions of interest in image processing software.	1 year
Secondary	Number of participants with improved contrast-to-noise ratio using new CACT vs. standard CACT	Contrast-to-noise ratio (unitless quantity) higher in new CACT images compared to standard CACT images, measured using regions of interest in image processing software.	1 year