IORT technology, based on the emission of high-energy electron beams for post-operative cancer treatment, is usually used in combination with traditional surgical techniques. The treatment applies the use of implanted filters to protect the underlying internal organs during radiation therapy. The IORT project involves the use of new materials and the 3D printing system to realise resistant, autoclavable, symmetric and radioprotection filters that are easy to implant.
These properties, along with the reduction of irradiation times (which represents lower doses of radiation for the patient), cost reduction and transportability, will facilitate the dissemination of IORT technology over traditional radiotherapy. This innovative system will ensure better therapies that are more focused on the main treatment area and reduce the impact on the patient.
The ultimate objective of the project is to demonstrate the functionality of an innovative radioprotection filter obtained by the combination of a biocompatible thermoplastic resin and a metallic shielding material for use in the operational environment. Thanks to the scientific partnership with the University of Trento, several tests will be conducted to assess any risks before clinical use becomes possible at the end of clinical trial process.
The project will create an innovative radioprotection filter from the combination of an innovative raw material as a biocompatible thermoplastic resin and a metallic shielding material with the use of a 3D printing system.
Therapy (IORT) technology is based on the emission of high-energy electron beams for post-operative cancer treatment. This technology is usually used in combination with traditional surgical techniques. The treatment, based on the emission of high-energy electron beams, applies the use of implanted filters to protect the underlying internal organs during the 20 minutes of radiation therapy.
The filters available on the market today are produced by combining Plexiglas and copper discs that are wound in a sterile sheath. This product is not autoclavable, fragile and asymmetric.
The intent of the project is to use new materials produced by using the 3D printing system, to realise autoclavable filters, which are particularly resistant, symmetric and simple to implant. These qualities, along with the reduction in irradiation times (which means lower doses of radiation to patient), cost reduction and transportability, will ensure the use of IORT technology over traditional radiotherapy.
This innovative system will ensure a better therapy, which is more focused on the main treatment and has less of a negative impact on the patient. The filters, produced with the state-of-the-art system, will be able to be used 10 times longer than the current filters and will not require a sterile sheath. Because the new filters will be reusable and result in reducing production costs, they will have a positive effect on the cost of therapy and add to environmental conservation by reducing hospital waste.
The final project objective is to demonstrate the functionality of this innovative radioprotection filter, obtained by the combination of a biocompatible thermoplastic resin and a metallic shielding material designed for the operational environment.
The project aims to achieve the 7th level on the Technology Readiness Level (TRL) scale by demonstrating the validity of this innovative filter. To realise this goal, the University of Trento will be involved as the scientific partner. This operative test requires a theoretical and instrumental preliminary confirmation in the suitably equipped laboratory of university to support the risk analysis for clinical use of the filter.
The analytic identification of risk factors will support the decision-making process, allowing the research team to decide between the full demonstration procedure on a patient-simulated mannequin or a complete therapy session performed on a controlled sample of volunteers which will be supported by clinical follow up, as described in the experimental procedures defined by the University of Trento.
In the second case the demonstration process will be completed and it will be possible to start the tool qualification phase of the medical device. Due to the complex procedures required by law, this phase will not be conducted during the project, since it will take too long to complete. For this reason, it will not be possible to achieve the 8th level in the TRL scale during the project timeline.
Starting date: 04/18/2017
End date: 06/30/2018
Total project: € 263.631,66
Total grant: € 189.641,05