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

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

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.

Study Overview

• Status: Unknown
• Conditions: Endovascular Procedures
• Intervention / Treatment: Procedure: Neurovascular percutaneous intervention

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Recruiting
      • Toronto Western Hospital - University Health Network
      • Contact: Vitor Pereira, MD; Phone Number: 5564 (416) 603 5800; Email: vitor.pereira@uhn.ca
      • Contact: Alex Kostynskyy, MBBS; Phone Number: 4806 (416) 603 5800; Email: alex.kostynskyy@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with neurovascular diseases and conditions that are amenable to endovascular treatment in the neuro-angiography suite.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neurovascular; Patients to receive percutaneous neurovascular intervention	Procedure: Neurovascular percutaneous intervention; Patient will receive one extra CACT scan while they are receiving percutaneous neurovascular intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Philips Healthcare
• Investigators: Principal Investigator: Vitor Pereira, MD, Associate Professor of Radiology and Surgery

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2017
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: May 17, 2017
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (Actual): May 22, 2017

Study Record Updates

• Last Update Posted (Actual): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: TWH-Version 2.0 Sept 28 2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No