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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Unknown status

CT.gov ID

NCT03162601

Collaborator

Philips Healthcare (Industry)

Enrollment

Location

30.9

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Endovascular Procedures	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 Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 4, 2017

Anticipated Primary Completion Date :

Nov 1, 2019

Anticipated Study Completion Date :

Nov 1, 2019

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Number of participants with improved new CACT image quality compared to standard CACT based on a 5-point Likert scale [1 year]
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.

Secondary Outcome Measures

Number of participants with a CACT image quality at the same level or better as standard CT based on a 5-point Likert scale [1 year]
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.
Number of participants with improved or equivalent contrast-to-noise ratio using new CACT vs. standard CT scans [1 year]
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.
Number of participants with improved contrast-to-noise ratio using new CACT vs. standard CACT [1 year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject is suitable for an endovascular treatment in the neuro-angiography suite.
Subject or subject's legally authorized representative has signed an institutionally approved research informed consent form.
Subject ≥ 18 years old.

Exclusion Criteria:

Subject or subject's legally authorized representative is unable or unwilling to consent to the study.
Subject had prior significant or severe allergy to intra-arterial contrast medium uncontrolled by pre-procedure medications.
Subject with documented contrast injection contraindication due to severe kidney disease or allergy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Toronto Western Hospital - University Health Network	Toronto	Ontario	Canada	M5T 2S8

Sponsors and Collaborators

University Health Network, Toronto
Philips Healthcare

Investigators

Principal Investigator: Vitor Pereira, MD, Associate Professor of Radiology and Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vitor Pereira, Associate Professor of Radiology and Surgery, University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT03162601

Other Study ID Numbers:

TWH-Version 2.0 Sept 28 2016

First Posted:

May 22, 2017

Last Update Posted:

Oct 16, 2018

Last Verified:

Oct 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 16, 2018