Periodic Reporting for period 1 - ORIGIN (Optical Fibre Dose Imaging for Adaptive Brachytherapy)
Reporting period: 2020-01-01 to 2021-06-30
Radiotherapy is the use of radiation for the treatment of cancer and 50 – 60 % of patients require radiotherapy at some point during their treatment. It is delivered in the form of external beam radiotherapy, using X-rays to kill cancer cells, or internally, using radioactive sources, in what is known as brachytherapy. Brachytherapy is further divided into Low Dose Rate (LDR), where the radioactive sources, known as seeds, remain implanted permanently, releasing radiation slowly over a number of months to destroy the cancer cells and High Dose Rate (HDR), where higher activity radiation sources are temporarily inserted into the target area for a few minutes at a time. Correct placement of the radiation source is vital to ensure adequate radiation to the target area (tumour), while ensuring minimum exposure to nearby critical organs, such as, in the case of prostate and gynaecological cancers, the bladder, urethra and rectal wall. Current positioning techniques rely on pre- and post-treatment CT and ultrasound imaging and the dose is calculated via a computerised treatment planning system. Without direct in person and real time monitoring of the dose being delivered to the patient, there is no independent dose verification, with many errors going undetected at the time of treatment.
ORIGIN aims to deliver more precise and effective brachytherapy for gynaecological and prostate cancer treatment through advanced real-time imaging and mapping of the radiation dose and exact location of the radiation source. This will be achieved by the development of a new 16-point optical fibre based sensor system for Low Dose Rate (LDR) and High Dose Rate (HDR) Brachytherapy. The ORIGIN system will lead to a 50% improvement in uncertainty over existing systems. In addition, the technology being developed will provide real-time monitoring of the radiation source location during treatment, which is currently not available. ORIGIN will be integrated into existing clinical brachytherapy treatment planning and delivery systems to confirm that the dose prescribed to the tumour is achieved, whilst ensuring the dose to organs at risk (OARs) is within acceptable limits. The optical fibre sensors that measure the radiation dose are being developed to maximise the accuracy and sensitivity of the readings. They are also being developed such that they can be fabricated repeatedly and consistently in high volumes, which is crucial for large-scale manufacturing.
ORIGIN aims to deliver more precise and effective brachytherapy for gynaecological and prostate cancer treatment through advanced real-time imaging and mapping of the radiation dose and exact location of the radiation source. This will be achieved by the development of a new 16-point optical fibre based sensor system for Low Dose Rate (LDR) and High Dose Rate (HDR) Brachytherapy. The ORIGIN system will lead to a 50% improvement in uncertainty over existing systems. In addition, the technology being developed will provide real-time monitoring of the radiation source location during treatment, which is currently not available. ORIGIN will be integrated into existing clinical brachytherapy treatment planning and delivery systems to confirm that the dose prescribed to the tumour is achieved, whilst ensuring the dose to organs at risk (OARs) is within acceptable limits. The optical fibre sensors that measure the radiation dose are being developed to maximise the accuracy and sensitivity of the readings. They are also being developed such that they can be fabricated repeatedly and consistently in high volumes, which is crucial for large-scale manufacturing.
The progress to date may be summarised as follows:
System Development:
• In order to measure the radiation, optical fibres have been designed with a special radiation-sensitive material, known as a scintillator, which converts the radiation into visible light. The amount of light is then measured by a detector. The detector system, which measures the light emitted by the optical fibres, has been defined and assembled. Initial testing was performed using a single channel system in a hospital environment for both LDR and HDR brachytherapy before advancing to a 16 channel system. The results confirm the choice of detector system and demonstrate the system’s capability and capacity.
• The first 16 channel prototype board has been designed and produced, ahead of schedule.
• The computer software that underlies the ability to map the dose and the location of the radiation source has been developed for LDR and HDR brachytherapy based on the optical signals from the 16 channel ORIGIN detector system.
Clinical Integration:
• The details of the hardware and software requirements for the seamless integration of the ORIGIN system with existing clinical treatment planning systems and dose delivery systems for HDR and LDR brachytherapy have been identified.
• Hospital clinicians who use brachytherapy systems were consulted in relation to the requirements and specifications of the ORIGIN system and how it will be integrated into current clinical workflows. A protocol that describes, step-by-step, how the ORIGIN system is used in the clinic to deliver real time, accurate dosing and the precise location of the radiation has been developed. The ability to monitor the treatment in real time allows the treatment to be stopped when critical deviation values are reached.
• The software that is required to optimise the performance of the system, ensuring that all the necessary data is readily available, displayed appropriately and able to communicate with other external systems has been defined.
• Initial protocols that describe how to evaluate and calibrate the project’s optical fibre sensors within High Dose Rate (HDR) and Low Dose Rate (LDR) brachytherapy for both prostate and gynaecological cancer treatment have been established.
• A reproduction of the relevant part of the human body has been designed and is currently being constructed using 3D printing technology. This will enable the examination of dose measurements in an anatomically correct model.
Manufacturability:
• Various mixtures of scintillators have been fabricated and examined in terms of their optical properties (e.g. the degree of light lost, light scatter and the bending of light as it travels through different materials) and their scintillating properties (the amount of light produced and over what timeframe).
• The design of the optical fibre sensor tip, which holds the scintillator, has also been optimised.
• A total of 9 batches of sample types containing scintillating material for HDR-BT and LDR-BT have been fabricated and evaluated for their performance and their ability to be mass produced.
• A regulatory assessment of the ORIGIN system was carried out to determine its medical device classification and the list of standards the device must meet before it can enter the market. A comprehensive business plan and commercialisation strategy has been developed for the ORIGIN system in order to pave the way for its long-term success.
System Development:
• In order to measure the radiation, optical fibres have been designed with a special radiation-sensitive material, known as a scintillator, which converts the radiation into visible light. The amount of light is then measured by a detector. The detector system, which measures the light emitted by the optical fibres, has been defined and assembled. Initial testing was performed using a single channel system in a hospital environment for both LDR and HDR brachytherapy before advancing to a 16 channel system. The results confirm the choice of detector system and demonstrate the system’s capability and capacity.
• The first 16 channel prototype board has been designed and produced, ahead of schedule.
• The computer software that underlies the ability to map the dose and the location of the radiation source has been developed for LDR and HDR brachytherapy based on the optical signals from the 16 channel ORIGIN detector system.
Clinical Integration:
• The details of the hardware and software requirements for the seamless integration of the ORIGIN system with existing clinical treatment planning systems and dose delivery systems for HDR and LDR brachytherapy have been identified.
• Hospital clinicians who use brachytherapy systems were consulted in relation to the requirements and specifications of the ORIGIN system and how it will be integrated into current clinical workflows. A protocol that describes, step-by-step, how the ORIGIN system is used in the clinic to deliver real time, accurate dosing and the precise location of the radiation has been developed. The ability to monitor the treatment in real time allows the treatment to be stopped when critical deviation values are reached.
• The software that is required to optimise the performance of the system, ensuring that all the necessary data is readily available, displayed appropriately and able to communicate with other external systems has been defined.
• Initial protocols that describe how to evaluate and calibrate the project’s optical fibre sensors within High Dose Rate (HDR) and Low Dose Rate (LDR) brachytherapy for both prostate and gynaecological cancer treatment have been established.
• A reproduction of the relevant part of the human body has been designed and is currently being constructed using 3D printing technology. This will enable the examination of dose measurements in an anatomically correct model.
Manufacturability:
• Various mixtures of scintillators have been fabricated and examined in terms of their optical properties (e.g. the degree of light lost, light scatter and the bending of light as it travels through different materials) and their scintillating properties (the amount of light produced and over what timeframe).
• The design of the optical fibre sensor tip, which holds the scintillator, has also been optimised.
• A total of 9 batches of sample types containing scintillating material for HDR-BT and LDR-BT have been fabricated and evaluated for their performance and their ability to be mass produced.
• A regulatory assessment of the ORIGIN system was carried out to determine its medical device classification and the list of standards the device must meet before it can enter the market. A comprehensive business plan and commercialisation strategy has been developed for the ORIGIN system in order to pave the way for its long-term success.
In addressing the need for more effective medical interventions and treatments for cancer, ORIGIN’s impact is three-fold: 1) improving health related quality of life outcomes 2) allowing for improved dose-led treatment plans and 3) avoiding treatment errors that result in patient misdosing. ORIGIN has the potential to reduce the overall risk of treatment error by 55%.
ORIGIN supports the realisation of the European technology platform Photonics21 healthcare philosophy "live longer, feel better", by providing for photonics-based diagnostics to monitor and assess treatment response and open the door to the practical implementation of personalised medicine. ORIGIN will redefine how our societies provide healthcare and in doing so establish Europe at the forefront of photonics-enabled radiation therapy. The successful integration of the ORIGIN system with existing treatment planning/delivery systems for accurate real-time monitoring of the dose delivered and radiation source location will provide industry with a unique selling point for ensuring industrial advantage for European brachytherapy companies. The delivery of a high-volume fabrication process for the radiation probes, together with a fabrication protocol transferrable to EU-funded pilot-lines or European based manufacturers, will ensure Europe competitiveness in photonics (optical fibre sensor) manufacturing.
ORIGIN supports the realisation of the European technology platform Photonics21 healthcare philosophy "live longer, feel better", by providing for photonics-based diagnostics to monitor and assess treatment response and open the door to the practical implementation of personalised medicine. ORIGIN will redefine how our societies provide healthcare and in doing so establish Europe at the forefront of photonics-enabled radiation therapy. The successful integration of the ORIGIN system with existing treatment planning/delivery systems for accurate real-time monitoring of the dose delivered and radiation source location will provide industry with a unique selling point for ensuring industrial advantage for European brachytherapy companies. The delivery of a high-volume fabrication process for the radiation probes, together with a fabrication protocol transferrable to EU-funded pilot-lines or European based manufacturers, will ensure Europe competitiveness in photonics (optical fibre sensor) manufacturing.