Analysis of Selective Cerebrovascular Distribution With FDCT in the Angiosuite

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:

1. What is the selective contribution of an individual bypass artery to the brain perfusion? 2. Is a selective intra-arterial angiographic perfusion examination useful in the decision-making of performing pre-operative embolization of intracranial tumors? 3. 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?

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Key information

Conditions

Ischemic Stroke Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hypoxia Cerebrovascular Disorders Hypoxia Hypoxia, Brain Intracranial Aneurysm Intracranial Arterial Diseases Intracranial Vascular Disorder Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antwerp University Hospital

Antwerp, België, 2018, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention group

Diagnostic Test

6s PBV mapping will be conducted

Other names: Flat-detector CT perfusion imaging

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

Evaluation of the Clinical Feasibility of Angiographic Flat-detector CT (FDCT) Perfusion Imaging (6sPBV) Technique.

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2021
First posted: Apr 16, 2019
Registry last updated: May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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