- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03916133
Analysis of Selective Cerebrovascular Distribution With FDCT in the Angiosuite
Evaluation of the Clinical Feasibility of Angiographic Flat-detector CT (FDCT) Perfusion Imaging (6sPBV) Technique.
The aim of this study is to evaluate the clinical feasibility of the angiographic Flat Detector CT perfusion imaging (6s PBV) technique. The investigators will examine the specific vessel distribution of patients with steno-occlusive disease, treated with a surgical extracranial-intracranial bypass and assess the cerebral perfusion during test occlusion upon a neurovascular treatment and in intracranial tumor patients referred for potential pre-operative embolization.
This study encompasses three scientific objectives:
- What is the selective contribution of an individual bypass artery to the brain perfusion?
- Is a selective intra-arterial angiographic perfusion examination useful in the decision-making of performing pre-operative embolization of intracranial tumors?
- What is the usefulness of performing additive 6s PBV images compared to classical 2D angiography and/or clinical neurological evaluation in case of test occlusion in the evaluation of possible mother vessel occlusion in treatment of complex neurovascular diseases?
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
België
-
Antwerp, België, Belgium, 2018
- Antwerp University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients referred for diagnostics and surgical (extracranial-intracranial bypass) treatment of steno-occlusive neurovascular disorders.
- Patients referred for hypervascular intracranial tumor resection
- Patients referred for angiographic test occlusion as part of treatment of complex neurovascular disorders.
Exclusion Criteria:
- Pregnant women or women trying to get pregnant
- People younger than 18 years old
- Patients with thyroid disorders and diabetes, especially those using medication with metformin.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Intervention group
Included patients will undergo angiographic FDCT perfusion imaging.The study will be embedded in the standard procedure of pre-operative diagnostics and angiographic control after EC-IC bypass treatment of steno-occlusive disease and during pre-embolization mapping and embolization procedure.
An informed consent will be acquired during consultations in the preparatory process of the different examinations and treatments
|
6s PBV mapping will be conducted
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance of flat-detector CT imaging in angiosuite
Time Frame: 1 day
|
The quality of the imaging scans obtained with FDCT will be assessed compared to conventional imaging techniques (CT, angiography and MRI)
|
1 day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18/17/222
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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