Better thermal-based EM therapeutics<\/p>\n\n\n\n
This group works on three focus areas: <\/p>\n\n\n\n
You can download the latest progress report here<\/a>.<\/p>\n\n\n\n First issued: September 2019 <\/p>\n\n\n\n Coordinated by<\/strong>: Gennaro Bellizzi<\/em> \u2013 g.bellizzi[at]erasmusmc.nl, Marta Cavagnaro<\/em> \u2013 marta.cavagnaro[at]uniroma1.it and Maarten Paulides<\/em> \u2013 m.m.paulides[at]tue.nl<\/p>\n\n\n\n Background and motivation<\/strong><\/p>\n\n\n\n Electromagnetic (EM) hyperthermic technologies hold\ngreat potential in the treatment of diseases, especially for cancers that are\nresistant to standard regimens. These technologies modify tissue temperature:\nhyperthermia heats the diseased tissue to make it susceptible to treatments,\nand ablation heats the tissue until it is destroyed. Overall, these techniques\nhave shown significant potential and there is substantial opportunity to\nsolidify their use clinically and to apply them to a wider range of medical\nconditions. <\/p>\n\n\n\n However, the increase in the market share of these\ntechniques doesn\u2019t reflect their potentialities nor the great number of\nresearchers working in these areas. Contributing to the stagnant market of EM\nhyperthermic medical devices is the fact that researchers working on the\ndevelopment of medical technologies are often not fully aware of the clinical\nchallenges related to these medical devices. Hence, workgroup (WG) 2 the MyWAVE\nAction takes a holistic approach, by bringing together key players in the field\nof fundamental and translational research and medical professionals, to create\na comprehensive overview of the clinical needs to be addressed with EM\nTherapeutics. In this way, we aim to stimulate and guide efforts into design\nand development of novel EM hyperthermic technologies, so that they can reach\npatients faster and improve treatment outcomes.<\/p>\n\n\n\n This deliverable is strictly related to the first milestone of the action,<\/p>\n\n\n\n Establish clinical needs that thermal-based interventions may be used to address.<\/strong><\/span><\/p>\n\n\n\n Following the discussion in the network, the identified clinical needs to be addressed with EM therapeutics were divided in four different categories, defined as:<\/p>\n\n\n\n 1. Devices and Device QA<\/span><\/p>\n\n\n\n 2. Treatment planning<\/span><\/p>\n\n\n\n 3. Real time dosimetry<\/span><\/p>\n\n\n\n 4. Quality assurance<\/span><\/p>\n\n\n\n Here below, the clinical needs are reported and discussed.<\/p>\n\n\n\n In view of ever-growing costs of\nhealthcare, it is of utmost importance to have affordable and competitive\nthermal therapy (hyperthermia and ablation) systems. Here not only the costs of\nthe system but also the total costs of ownership (acquisition, operation and\nmaintenance) are important. These combined costs should balance well against\nthe benefits, which is often expressed in the costs per quality adjusted life\nyear (costs per QALY). The threshold for introduction is country dependent but\nfor e.g. the Netherlands in the range of 20.000 \u20ac or 80.000 \u20ac per QALY for low\nor high-tech medical systems, respectively.<\/p>\n\n\n\n Reproducibility of system\u2019s performance\nover its life time has a pivotal role in encouraging thermal therapies clinical\nacceptance. This item states the need of developing appropriate standard\nprocedures to verify system QA compliance before entering the market (see\nsection 4). Additionally, standard procedures are needed to verify systems\nperformances during their lifetime, to look for possible degradation due to the\nuse. These procedures should be easy and quick to perform but they should be\nrepeated over a regular basis and appropriately reported. Finally, procedures\nto verify system performances during the delivery of the treatment are needed;\nthey should foresee suitable measurements to be performed, possibly without\ninterfering with the treatment. <\/p>\n\n\n\n This item is related to magnetic field\nhyperthermia, wherein the heating is mediated by the targeting of a magnetic\nfluid (e.g. contrast agent). The\nrelated needs are the definition of the dose of the magnetic fluid to be\ninjected in the tissue, and the development of prediction tools for the\nmagnetic nanoparticle (MNP) distribution and the related distribution of the\ntemperature increase within the target tissue<\/p>\n\n\n\n Definition of case-studies to be used to validate\nthe software used for treatment planning should be defined. Moreover, methods\nto verify veracity of the achieved results and their applicability in the\nclinical settings should be defined.<\/p>\n\n\n\n Dielectric\nand thermal properties of human body tissues are crucial in the accuracy of 3D\nelectromagnetic and thermal simulations. These simulations are becoming\ninevitable for optimizing treatment settings before or during treatment, as\nwell as for optimized device designs. Important in this respect are also the temperature\nand time (thermoregulation) dependence of the (EM&T) tissue properties. In\naddition, these values are very different among different patients, different\nbiological tissues, and among benign, malign and normal tissue. <\/p>\n\n\n\n Therapy outcome critically depends on the\noptimization of the correct performance parameter. In thermal therapies,\nseveral parameters, based on Specific Absorption Rate (SAR), temperature, and\/or\nthermal dose exist, but their validation against clinical outcome is sparse. <\/p>\n\n\n\n Tissue properties are not known with the\nrequired accuracy; accordingly, comprehensive methods to deal with these uncertainties\nare required to design the best devices and provide the clinicians insight in\nmodelling uncertainties.<\/p>\n\n\n\n Treatment planning tools should be operator\nfriendly and the combination of tool and procedures should make the treatment\noperator independent.<\/p>\n\n\n\n Invasive thermometry is long being used for documentation of the treatment but, although guidelines exists, these are not standardly applied due to their complexity. A revision of the guidelines is required.<\/p>\n\n\n\n A number of tools are under development (MRI-,\nsimulation- and drug-delivery based) for non-invasive real-time dose assessment\nbut clinical validation and standardisation are still highly required. <\/p>\n\n\n\n The definition of Key Performances Indicators to test and compare the different tools is highly recommended.<\/p>\n\n\n\n The biological mechanisms of action,\ndifferent between hyperthermia and thermal ablation, should be investigated to\nallow defining the relation between the \u201cthermal dose\u201d and tissue damage, as\nwell as to translate in-vitro\/ex-vivo findings and evaluation methods to\nin-vivo. This investigation should tackle the diverse characteristics of normal\nand cancerous tissues, that have different time-temperature dependent tolerance\nagainst heat. <\/p>\n\n\n\n In addition, in hyperthermia treatments, repeated\napplication of heat might lead to thermotolerance. <\/p>\n\n\n\n A deep investigation of applicability of\nCEM43 in the different tissues is needed<\/p>\n\n\n\n Quality assurance protocols, accepted by the authorised organisations (e.g. ESHO, STM, etc.) should be defined. They should form the basis for deriving protocols per device, treatment planning and treatment quality monitoring technology.<\/p>\n\n\n\n Creation of repository of all performed treatments would help exchange of information and experiences and development of meta-analysis to prove efficacy of the treatments and related parameters to maintain under control.<\/p>\n\n\n\n A common lexicon should be developed to\nhelp correct exchange of information among the different disciplines involved\nin EM-based therapeutics, e.g., clinicians, engineers, physicians, biologists,\netc<\/p>\n\n\n\n The above-listed clinical needs delineate several\nresearch lines to be followed by the community to help improving clinical\napplication of electromagnetics therapies. They will be the object of the work\nundertaken by the MyWave network. In particular, following the roadmap of the\naction, future efforts will be devoted to the discussion of standardized\nsimulations for treatment planning, aiming at investigating the deficiencies\nand challenges in existing treatment protocols, and new approaches in treatment\nplanning and standardization. <\/p>\n\n\n\n <\/p>\n\n\n\n This group works on three focus areas: optimising the technology for existing thermal-based EM applications and developing ideas for novel clinical applications, improving Treatment Planning protocols, improving Quality Assurance (QA) of existing thermal-based EM technologies. You can download the latest progress report here. Establishing the needs for Standardisation in EM hyperthermic technologies. Clinical needs to […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":28,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-47","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.um.edu.mt\/projects\/mywave\/wp-json\/wp\/v2\/pages\/47","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.um.edu.mt\/projects\/mywave\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.um.edu.mt\/projects\/mywave\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.um.edu.mt\/projects\/mywave\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.um.edu.mt\/projects\/mywave\/wp-json\/wp\/v2\/comments?post=47"}],"version-history":[{"count":15,"href":"https:\/\/www.um.edu.mt\/projects\/mywave\/wp-json\/wp\/v2\/pages\/47\/revisions"}],"predecessor-version":[{"id":985,"href":"https:\/\/www.um.edu.mt\/projects\/mywave\/wp-json\/wp\/v2\/pages\/47\/revisions\/985"}],"up":[{"embeddable":true,"href":"https:\/\/www.um.edu.mt\/projects\/mywave\/wp-json\/wp\/v2\/pages\/28"}],"wp:attachment":[{"href":"https:\/\/www.um.edu.mt\/projects\/mywave\/wp-json\/wp\/v2\/media?parent=47"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Establishing the needs for Standardisation in EM hyperthermic technologies.<\/a><\/h4>\n\n\n\n
Clinical needs to be addressed with EM Therapeutics (Deliverable 2.1)<\/em><\/h4>\n\n\n\n
1 \u2013 Devices and Device QA<\/h4>\n\n\n\n
2 \u2013 Treatment planning<\/h4>\n\n\n\n
3 \u2013 Realtime dosimetry <\/h4>\n\n\n\n
5 \u2013 Quality assurance<\/h4>\n\n\n\n
6 \u2013 Conclusions and future perspectives<\/h4>\n\n\n\n
Procedure towards the\nfinal draft of D2.1:<\/h4>\n\n\n\n