Clinical trial NCT03162601: C-arm Computed Tomography Scan Image Quality in Patients With Neurovascular Diseases
Official title: C-arm Computed Tomography Scan Image Quality in Patients With Neurovascular Diseases: Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endovascular Procedures
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
First posted: 2017-05-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with improved new CACT image quality compared to standard CACT based on a 5-point Likert scale
timeFrame: 1 year
Secondary outcomes:
measure: Number of participants with a CACT image quality at the same level or better as standard CT based on a 5-point Likert scale
timeFrame: 1 year
measure: Number of participants with improved or equivalent contrast-to-noise ratio using new CACT vs. standard CT scans
timeFrame: 1 year
measure: Number of participants with improved contrast-to-noise ratio using new CACT vs. standard CACT
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital - University Health Network
state: Ontario
Study officials:
affiliation: Associate Professor of Radiology and Surgery
name: Vitor Pereira, MD
role: PRINCIPAL_INVESTIGATOR
References: