Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588543
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Patient-specific Planning of Minimally Invasive Brain Interventions Based on Vascular-hemodynamic Mapping
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Patient-specific Planning of Minimally Invasive Brain Interventions Based on Vascular-hemodynamic Mapping
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Endovascular procedures for treating brain aneurysms and arteriovenous malformations AVMs are becoming increasingly popular due to their less invasive nature and lower risk of complications However they still face challenges such as difficult catheter navigation and incomplete embolization
This study aims to improve the efficiency and safety of endovascular procedures by developing new preoperative planning methodologies These methodologies involve mapping the cerebral vasculature and creating computational fluid dynamics CFD and artificial intelligence AI models to simulate blood flow By using these models interventional radiologists can better plan catheter navigation and predict embolization outcomes This could lead to faster more accurate procedures with reduced radiation exposure for patients
This study aims to improve the efficiency and safety of endovascular procedures by developing new preoperative planning methodologies These methodologies involve mapping the cerebral vasculature and creating computational fluid dynamics CFD and artificial intelligence AI models to simulate blood flow By using these models interventional radiologists can better plan catheter navigation and predict embolization outcomes This could lead to faster more accurate procedures with reduced radiation exposure for patients
Detailed Description:
The number of treatments of blood vessels using a catheter inserted into a blood vessel also known as endovascular treatment has been increasing over the past decades There are several advantages associated with this technique such as that it is less invasive and carries a lower risk of complications This technique is expected to become the preferred treatment for intracranial aneurysms and arteriovenous malformations AVMs
Despite the advantages of endovascular procedures there are still technical challenges that can affect their effectiveness and safety In clinical practice a guidewire approximately 15 to 20 m is directed under fluoroscopic imaging to the specific brain area Accurately navigating the tip of a passive guidewire by manipulating the proximal end requires many years of experience and can be a cumbersome task even for experienced interventional radiologists Moreover navigating the catheter to the target brain area can already take up a large part of the procedure time A second challenge is the risk of incomplete embolization or recanalization The risk of incomplete embolization is particularly present in AVMs as they have a complex structure The performance of an embolization can cause the hemodynamic in that particular brain region to change resulting in other preferential flow paths which can later lead to another embolization procedure This creates a need for repeated angiographic evaluation which also leads to longer and more expensive procedures and higher exposure to radiation for the patient The above challenges show that there is a need for a method that allows for faster and more efficient neurological interventions with the patient receiving a lower dose of radiation and a higher probability of complete and lasting embolization
The goal of the study is to develop a new methodology for preoperative planning of catheter navigation and embolization based on mapping of the cerebral vasculature and modelling of blood flow through the associated arterial vasculature In cardiology there are already techniques for guided navigation of the guidewire or other tool without the need for fluoroscopic guidance In these techniques the patient-specific vasculature is mapped with a detailed 3D representation of the vascular network displayed together with tracking of the position of the catheter relative to this map in a correct 3D reference frame However these techniques have not yet been extended to neurovascular interventions since the cerebral vasculature is an intrinsically complex arterial vasculature
For the current study there are two main objectives The first primary objective of this research is to map the cerebral vasculature by quantifying and analysing 3D angiographic data with the aim of assessing the accessibility of the vasculature for catheter navigation and supporting catheter tracking
The second main objective is to develop and validate computational fluid dynamics CFD and artificial intelligence AI models of cerebral blood flow with the aim of supporting preoperative planning These AI models serve to accelerate the CFD models The clinical aspect of this study only involves the collection of retrospective and prospective patient data so there is no additional clinical risk for the patient Preferably medical images cerebral MRI images resolution 03 - 05 mm 3D rotational angiography 3DRA resolution 005 - 028 mm biplanar digital subtraction angiography DSA resolution 015 - 062 mm together with a case report form CRF including therapy parameters and response After data collection patient-specific models of the accessibility of the vasculature and fluid distribution in the cerebral blood vessels will be developed on the side of UGent research groups IbiTech BioMMedA MEDISIP Department of Electronics and Information Systems and research group IPI Department of Telecommunications and Information Processing both belonging to the Faculty of Engineering and Architecture at UGent Medical images play a crucial role in the development and validation of these models Once these models have been validated including using in vitro models with 3D-printed phantoms they may also be used in clinical applications in the longer term Validation of these models in a clinical interventional setting is not yet applicable for this study
Despite the advantages of endovascular procedures there are still technical challenges that can affect their effectiveness and safety In clinical practice a guidewire approximately 15 to 20 m is directed under fluoroscopic imaging to the specific brain area Accurately navigating the tip of a passive guidewire by manipulating the proximal end requires many years of experience and can be a cumbersome task even for experienced interventional radiologists Moreover navigating the catheter to the target brain area can already take up a large part of the procedure time A second challenge is the risk of incomplete embolization or recanalization The risk of incomplete embolization is particularly present in AVMs as they have a complex structure The performance of an embolization can cause the hemodynamic in that particular brain region to change resulting in other preferential flow paths which can later lead to another embolization procedure This creates a need for repeated angiographic evaluation which also leads to longer and more expensive procedures and higher exposure to radiation for the patient The above challenges show that there is a need for a method that allows for faster and more efficient neurological interventions with the patient receiving a lower dose of radiation and a higher probability of complete and lasting embolization
The goal of the study is to develop a new methodology for preoperative planning of catheter navigation and embolization based on mapping of the cerebral vasculature and modelling of blood flow through the associated arterial vasculature In cardiology there are already techniques for guided navigation of the guidewire or other tool without the need for fluoroscopic guidance In these techniques the patient-specific vasculature is mapped with a detailed 3D representation of the vascular network displayed together with tracking of the position of the catheter relative to this map in a correct 3D reference frame However these techniques have not yet been extended to neurovascular interventions since the cerebral vasculature is an intrinsically complex arterial vasculature
For the current study there are two main objectives The first primary objective of this research is to map the cerebral vasculature by quantifying and analysing 3D angiographic data with the aim of assessing the accessibility of the vasculature for catheter navigation and supporting catheter tracking
The second main objective is to develop and validate computational fluid dynamics CFD and artificial intelligence AI models of cerebral blood flow with the aim of supporting preoperative planning These AI models serve to accelerate the CFD models The clinical aspect of this study only involves the collection of retrospective and prospective patient data so there is no additional clinical risk for the patient Preferably medical images cerebral MRI images resolution 03 - 05 mm 3D rotational angiography 3DRA resolution 005 - 028 mm biplanar digital subtraction angiography DSA resolution 015 - 062 mm together with a case report form CRF including therapy parameters and response After data collection patient-specific models of the accessibility of the vasculature and fluid distribution in the cerebral blood vessels will be developed on the side of UGent research groups IbiTech BioMMedA MEDISIP Department of Electronics and Information Systems and research group IPI Department of Telecommunications and Information Processing both belonging to the Faculty of Engineering and Architecture at UGent Medical images play a crucial role in the development and validation of these models Once these models have been validated including using in vitro models with 3D-printed phantoms they may also be used in clinical applications in the longer term Validation of these models in a clinical interventional setting is not yet applicable for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None