Endovascular ProceduresNCT03162601
C-arm Computed Tomography Scan Image Quality in Patients With Neurovascular Diseases
An observational study of Endovascular Procedures, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endovascular Procedures
- What is being tested?
- Neurovascular percutaneous intervention
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 4 Apr 2017to 1 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with neurovascular diseases and conditions that are amenable to endovascular treatment in the neuro-angiography suite.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital - University Health Network
Toronto, Ontario, M5T 2S8
Vitor Pereira, MD, (416) 603 5800 ext. 5564, vitor.pereira@uhn.ca
Alex Kostynskyy, MBBS, (416) 603 5800 ext. 4806, alex.kostynskyy@uhn.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Endovascular Procedures
- Being tested
- Neurovascular percutaneous intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurovascular percutaneous interventionProcedure or surgery
Patient will receive one extra CACT scan while they are receiving percutaneous neurovascular intervention.
| Study group | Role | What they receive |
|---|---|---|
| Neurovascular | Patients to receive percutaneous neurovascular intervention Receives: Procedure: Neurovascular percutaneous intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start4 Apr 2017
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endovascular ProceduresStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare
- Responsible party
- Principal investigator, Vitor Pereira, University Health Network, Toronto
- Investigators
- Vitor Pereira, MD, Principal investigator, Associate Professor of Radiology and Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162601
- Sponsor's protocol ID
- TWH-Version 2.0 Sept 28 2016
- Status last verified
- Oct 2018
- First submitted
- 17 May 2017
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C-arm Computed Tomography Scan Image Quality in Patients With Neurovascular Diseases: Observational Study
- ClinicalTrials.gov ID
- NCT03162601
- Acronym / sponsor ID
- TWH-Version 2.0 Sept 28 2016
- Conditions
- Endovascular Procedures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Philips Healthcare
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurovascular | – | Procedure: Neurovascular percutaneous interventionPatients to receive percutaneous neurovascular intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with neurovascular diseases and conditions that are amenable to endovascular treatment in the neuro-angiography suite.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurovascular percutaneous interventionPatient will receive one extra CACT scan while they are receiving percutaneous neurovascular intervention. | Procedure or surgery | Neurovascular |
Primary outcome
Number of participants with improved new CACT image quality compared to standard CACT based on a 5-point Likert scale
Time frame: 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.
3 secondary outcomes
Number of participants with a CACT image quality at the same level or better as standard CT based on a 5-point Likert scale
Time frame: 1 year
Number of participants with improved or equivalent contrast-to-noise ratio using new CACT vs. standard CT scans
Time frame: 1 year
Number of participants with improved contrast-to-noise ratio using new CACT vs. standard CACT
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vitor Pereira, MD principal investigator
Associate Professor of Radiology and Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endovascular Procedures, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vitor Pereira, MD ((416) 603 5800 ext. 5564, vitor.pereira@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with improved new CACT image quality compared to standard CACT based on a 5-point Likert scale (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018; AzTrials last refreshed its copy on 27 Oct 2026.