Periodic Reporting for period 2 - NEXIS (Next generation X-ray imaging system)
Reporting period: 2019-07-01 to 2021-12-31
Stroke is the second most common cause of death globally (WHO) and the leading cause of acquired neurological disability. The current workflow is far from ideal because transportation of the patient to the CT scanner for diagnosis and from there to the interventional room for treatment takes unnecessarily long time. NEXIS targeted a photonics driven breakthrough in image quality of an interventional X-ray system to allow stroke diagnosis directly in the treatment suite.
The overarching NEXIS project objective is to develop and integrate a novel spectral X-ray detector including the related advanced image processing in an interventional X-ray system and to evaluate the clinical performance of the achieved spectral CT-like imaging capability for stroke diagnosis.
A photonics driven breakthrough in image quality and functionality of an interventional X-ray system will allow to perform stroke diagnosis directly in the treatment suite and have a huge impact: enhanced workflow, reduced diagnosis & treatment time (up to 50 % time reduction) which will save people’s life and reduce healthcare costs.
NEXIS developed an X-ray system for enhanced Cone Beam CT imaging while keeping high spatial resolution for 2D image guidance by an innovative spectral X-ray detector. Related image processing (including deep learning) was developed and explored, as well as new key photonic components: A novel thin foil-based image sensor for use in an optimized multi-layer detector and a 3D printed pixelated CT-like scintillator with high spatial resolution to prepare future enhanced Cone Beam CT imaging. The usability and applicability of a first spectral NEXIS X-ray system for stroke imaging was clinically evaluated in a European top hospital.
The multidisciplinary consortium of the project covered the full value chain (photonics R&D, medical system integrator, application owner, supply chain and equipment manufacturing). The project allowed key players in the European medical photonics industry to generate increased future sales and stay competitive by providing new X-ray imaging components and EU based manufacturing. NEXIS will strengthen European competitiveness by developing spectral detector technologies that meet the needs of the European and global X-ray image detectors market. In the coming decade NEXIS is expected to initiate the transition of standard (black&white) to spectral (colour) X-ray detectors, which will improve performance and functionality of X-ray imaging systems.
The overarching NEXIS project objective is to develop and integrate a novel spectral X-ray detector including the related advanced image processing in an interventional X-ray system and to evaluate the clinical performance of the achieved spectral CT-like imaging capability for stroke diagnosis.
A photonics driven breakthrough in image quality and functionality of an interventional X-ray system will allow to perform stroke diagnosis directly in the treatment suite and have a huge impact: enhanced workflow, reduced diagnosis & treatment time (up to 50 % time reduction) which will save people’s life and reduce healthcare costs.
NEXIS developed an X-ray system for enhanced Cone Beam CT imaging while keeping high spatial resolution for 2D image guidance by an innovative spectral X-ray detector. Related image processing (including deep learning) was developed and explored, as well as new key photonic components: A novel thin foil-based image sensor for use in an optimized multi-layer detector and a 3D printed pixelated CT-like scintillator with high spatial resolution to prepare future enhanced Cone Beam CT imaging. The usability and applicability of a first spectral NEXIS X-ray system for stroke imaging was clinically evaluated in a European top hospital.
The multidisciplinary consortium of the project covered the full value chain (photonics R&D, medical system integrator, application owner, supply chain and equipment manufacturing). The project allowed key players in the European medical photonics industry to generate increased future sales and stay competitive by providing new X-ray imaging components and EU based manufacturing. NEXIS will strengthen European competitiveness by developing spectral detector technologies that meet the needs of the European and global X-ray image detectors market. In the coming decade NEXIS is expected to initiate the transition of standard (black&white) to spectral (colour) X-ray detectors, which will improve performance and functionality of X-ray imaging systems.
The main activities of the consortium during the first project period were to work together towards the main concepts of the project, down to detailed specifications. These common activities were also typical subjects for break-out sessions during the regular face to face consortium meetings. The objectives related to these activities that were achieved in the first reporting period are:
• Definition of clinical requirements, architecture and design for the system in the hospital.
• Definition of requirements, architecture and design for the demonstrators of the different novel photonic components such as image sensor on foil, 3D printed scintillator and multi-layer detectors.
• Exploration of clinical requirements for the (spectral) algorithms. Full physical modelling and simulations to facilitate the discussions and to enable early evaluations of the algorithms.
• Prototyping of different hardware and software components and their first technical validations on component level, followed by (sub) integration of components and technical validations (WP2, WP3, WP4, WP5) up to first integration steps on system level (WP6).
The main activities of the consortium during the second project period were to continue to work together towards the main goals of the project. These activities were also typical subjects for break-out sessions during the regular face to face (or virtual) consortium meetings. The objectives related to these activities that were achieved in the second reporting period are:
- Release and approvals for clinical study and investigational device
- System integration in the hospital
- Validation of (spectral) simulations & processing
- Phantom study in the hospital
- Clinical study in the hospital
- Demonstrations of further developed advanced image processing and large area demonstrators of novel X-ray components
From managerial point of view an objective was to facilitate the co-operation of the consortium and co-ordinate and lead the overall project towards the final goal of stroke diagnosis in the interventional room (WP8) using the power of innovative photonics (WP2, WP5) with related advanced image processing (WP3, WP4) and following the clinical leadership of the hospital team (WP6).
• Definition of clinical requirements, architecture and design for the system in the hospital.
• Definition of requirements, architecture and design for the demonstrators of the different novel photonic components such as image sensor on foil, 3D printed scintillator and multi-layer detectors.
• Exploration of clinical requirements for the (spectral) algorithms. Full physical modelling and simulations to facilitate the discussions and to enable early evaluations of the algorithms.
• Prototyping of different hardware and software components and their first technical validations on component level, followed by (sub) integration of components and technical validations (WP2, WP3, WP4, WP5) up to first integration steps on system level (WP6).
The main activities of the consortium during the second project period were to continue to work together towards the main goals of the project. These activities were also typical subjects for break-out sessions during the regular face to face (or virtual) consortium meetings. The objectives related to these activities that were achieved in the second reporting period are:
- Release and approvals for clinical study and investigational device
- System integration in the hospital
- Validation of (spectral) simulations & processing
- Phantom study in the hospital
- Clinical study in the hospital
- Demonstrations of further developed advanced image processing and large area demonstrators of novel X-ray components
From managerial point of view an objective was to facilitate the co-operation of the consortium and co-ordinate and lead the overall project towards the final goal of stroke diagnosis in the interventional room (WP8) using the power of innovative photonics (WP2, WP5) with related advanced image processing (WP3, WP4) and following the clinical leadership of the hospital team (WP6).
NEXIS has provided a first investigational device detector and system for clinical evaluation of innovative CBCT imaging using a dual layer X-ray detector and related advanced image processing in the interventional suite of a comprehensive stroke center.
Stroke care and treatment is a major challenge for healthcare providers across the globe. In many cases, particularly for patients who have experienced an acute stroke, ‘Time is Brain’ – meaning that the right treatment at the right time could potentially lead to enhanced patient outcomes. Source: www.world-stroke.org/assets/downloads/WSO_Annual_Report_2020_online.pdf
NEXIS detector
Trixell will take the next steps to bring a first spectral X-ray detector towards production in the coming years. The manufacturing of the detector will be in Europe (Trixell, Moirans, France) and the partners involved in the Trixell joint-venture will profit from the availability of state of the art Trixell dual layer detectors. Overall the market perspective for this type of detector is very good.
Global X-ray detector market
The global X-Ray detector market predicted by Yole [1] is a total size of 2.0 B$ in 2018 and 2.8 B$ in 2024, at a growth rate of 5.9%. This market consists of four different application domains (medical, security, veterinary and industrial), of which medical has by far the largest market share (69%). According to Yole, the global medical X-ray detector market will increase at CAGR of 4.5% from 1.5 B$ in 2018 to 1.9 B$ in 2024. The market value breakdown in 2024 is estimated to be: 47% static + 21% dynamic + 13% CT + 12% dental + 7% mammo.
Impacts on employment in the manufacturing regions
The NEXIS results will have a direct positive impact on labour at production sites from Trixell and its partners in the European supply chain. Development and manufacturing of innovative NEXIS X-ray detectors and systems in Europe will prevent this additional employment to move to Asia and US where IR and DR X-ray competitors are very innovative as well. Furthermore, competitiveness of European healthcare industry will be strengthened by developing innovative products and services that meet the growing needs of the European and global X-ray image sensors markets.
[1] Yole Development, ”X-ray detectors for medical, industrial and security applications”, Market and Technology Report, May 2019
Stroke care and treatment is a major challenge for healthcare providers across the globe. In many cases, particularly for patients who have experienced an acute stroke, ‘Time is Brain’ – meaning that the right treatment at the right time could potentially lead to enhanced patient outcomes. Source: www.world-stroke.org/assets/downloads/WSO_Annual_Report_2020_online.pdf
NEXIS detector
Trixell will take the next steps to bring a first spectral X-ray detector towards production in the coming years. The manufacturing of the detector will be in Europe (Trixell, Moirans, France) and the partners involved in the Trixell joint-venture will profit from the availability of state of the art Trixell dual layer detectors. Overall the market perspective for this type of detector is very good.
Global X-ray detector market
The global X-Ray detector market predicted by Yole [1] is a total size of 2.0 B$ in 2018 and 2.8 B$ in 2024, at a growth rate of 5.9%. This market consists of four different application domains (medical, security, veterinary and industrial), of which medical has by far the largest market share (69%). According to Yole, the global medical X-ray detector market will increase at CAGR of 4.5% from 1.5 B$ in 2018 to 1.9 B$ in 2024. The market value breakdown in 2024 is estimated to be: 47% static + 21% dynamic + 13% CT + 12% dental + 7% mammo.
Impacts on employment in the manufacturing regions
The NEXIS results will have a direct positive impact on labour at production sites from Trixell and its partners in the European supply chain. Development and manufacturing of innovative NEXIS X-ray detectors and systems in Europe will prevent this additional employment to move to Asia and US where IR and DR X-ray competitors are very innovative as well. Furthermore, competitiveness of European healthcare industry will be strengthened by developing innovative products and services that meet the growing needs of the European and global X-ray image sensors markets.
[1] Yole Development, ”X-ray detectors for medical, industrial and security applications”, Market and Technology Report, May 2019