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

NCT03162601 | Unknown

• 1 other identifier: TWH-Version 2.0 Sept 28 2016
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Endovascular Procedures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Number of participants with improved or equivalent contrast-to-noise ratio using new CACT vs. standard CT scans

  1 year

• Number of participants with improved contrast-to-noise ratio using new CACT vs. standard CACT

  1 year

Study Arms (1)

Neurovascular

Patients to receive percutaneous neurovascular intervention

Procedure: Neurovascular percutaneous intervention

Interventions

Neurovascular percutaneous intervention PROCEDURE

Patient will receive one extra CACT scan while they are receiving percutaneous neurovascular intervention.

Neurovascular

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Philips Healthcare: collaborator

Study Sites (1)

Toronto Western Hospital - University Health Network

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

Study Officials

• Vitor Pereira, MD

  Associate Professor of Radiology and Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vitor Pereira, MD

CONTACT

(416) 603 5800; vitor.pereira@uhn.ca

Alex Kostynskyy, MBBS

CONTACT

416-603-5800; alex.kostynskyy@uhn.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiology and Surgery

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 22, 2017
• Study Start: April 4, 2017
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: October 16, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)