(accordion: open) (accordion: openscale title: What types of hyperthermia are there?) First of all, it is useful to make the distinction between active and passive hyperthermia. The aim of active hyperthermia, which is also called fever therapy, is to increase the body temperature using bacterial toxins or by influencing the cytokines. However, today the term “hyperthermia” is usually used in the sense of passive hyperthermia whereby the heat is introduced or induced externally. Differences here include: a. Whole-body hyperthermia To treat tumours/metastases that have spread to multiple organs or systemic tumour illnesses b. Surface hyperthermia To treat skin tumours and metastases (suitable for treatment using Celsius TCS - Tumor Cell Solution) c. Regional deep hyperthermia To treat solid tumours in organs such as the liver, lungs, brain, pelvic area and the like (suitable for treatment using Celsius TCS - Tumor Cell Solution) d. Perfusion hyperthermia For hyperthermal perfusion of metastasised hollow organs or spaces e. Interstitial thermotherapy Special targeted method (accordion: openscale title: For which types of tumour can Celsius TCS - Tumor Cell Solution be used?) The Celsius TCS Hyperthermia System is indicated for the treatment of solid tumors in curative and palliative therapies, including - Gynaecological malignancies (e.g. breast, ovary, cervix etc.) - Malignant tumors in organs - Deep seated cancer lesions (e.g. brain, liver, lung, kidney, pancreas, etc.) - Lymph node metastases - Gastrointestinal tumors (e. g. esophagus, colon etc.) - Sarcomas, melanomas, basaliomas, etc. (accordion: openscale title: What are the contraindications of regional deep hyperthermia?) The following contraindications are described: Pregnant patients There are no analyses of the mode of action of hyperthermia in pregnant women. An exclusion is necessary at all times, as the risks to both the embryo and pregnant women are not known. Metal implants Patients with metal hip or knee implants and/or screws, with ingrown metal splinters or balls or with metal teeth implants could suffer burns near the metal implants, as metals, in particular, heat up excessively under the influence of energetic radio waves. Hence, tumour position, region, and logo-regional deep hyperthermia need to be taken into account. Pacemaker Ask about pacemakers and similar electrodes as one cannot rule out the possibility of damaging the electronics of the pacemaker and thus causing malfunctions. Disturbed perception of temperature Patients exhibiting a disturbed perception of temperature (e.g. after a stroke or pain drug intake) require special attention. The overheated areas need to be watched continuously (e.g. avoid accumulations of perspiration: can cause burn blisters and generally affect the circulation and comfort of the patient). Unstable cardiovascular system This is a relative contraindication as this form of therapy poses a relatively low burden on the entire system. Nevertheless, patients with an unstable cardiovascular system need to be watched especially closely (RR measurements), since the cardiovascular system can be more unstable (lower) when sitting up following treatment. Patients with a bone marrow or stem cell transplant Treatment with the Celsius TCS - Tumor Cell Solution must not be used in patients who have had bone marrow transplants. Open wounds Patients with open wounds in the treatment area must not be treated. Scar tissue, damaged skin Energy absorption in the subcutaneous fatty tissue during localized hyperthermia can result in fatty tissue burns or fatty tissue fibrosis. Localized cooling or pain therapy is usually sufficient. Epilepsy Continuous supervision is required for patients with epilepsy, since an epileptic seizure can also not be excluded during the hyperthermia session. Patients under anesthesia Patients under anesthesia may not be treated under any circumstances. A sedated patient has a significantly reduced pain perception. As a rule, the patient should be responsive and continuously monitored by trained professionals. The therapy recommendations can be used to support complementary therapies. (accordion: openscale title: Is treatment with Celsius TCS - Tumor Cell Solution painful and what are the side effects?) In contrast to surgery, chemotherapy and radiation therapy, hyperthermia has almost no side effects. On the contrary: patients often report feeling the positive, calming benefits of the heat. They regularly report a “calming” sensation and reduced stress. Some tiredness can occur after treatment. In rare cases, the increased death of malignant cells can result in slight fever spikes. In general, however, this is considered to be a positive physical sign. Patients with a disrupted perception of temperature (for example following a stroke) must be observed constantly during treatment. The hyperthermia area must be monitored continuously throughout the procedure (i.e. to avoid sweat accumulation; sweat can heat up excessively and result in blisters on the skin). Otherwise, every patient is given a push-button that can be used at any time to interrupt the treatment if he/she feels an uncomfortable heat sensation. (accordion: openscale title: Why is regional deep hyperthermia suitable as a complementary method to radiation therapy?) Different mechanisms are responsible for the supra-additive effect of hyperthermia when used in conjunction with radiotherapy. The additive, complementary effect of hyperthermia is due to the higher heat sensitivity of cells in the S phase, which are relatively radio-resistant. Hyperthermia can also cause increased blood flow and thus increased tissue oxygenation, which results in increased radio-sensitivity. Therefore, it is best to perform hyperthermia before or during radiotherapy; alternatively, hyperthermia can also be administered immediately after radiation. Hyperthermia increases cytotoxic radiation effects, particularly by interfering with the cellular repair system as a result of the denaturing of the DNA. In vivo studies have shown that hyperthermia can boost the effect of radiotherapy by a factor of 1.2 to 5. Hyperthermia is probably the most potent radio-sensitising method currently known. (accordion: openscale title: Regional hyperthermia as a complementary treatment to radiotherapy) The primary mechanism of radiotherapy is the generation of free oxygen radicals by ionising radiation, which in turn attack the DNA of tumour cells. Cells low in oxygen are three times more resistant to gamma radiation than normal cells. This is where hyperthermia can be a complementary treatment. Due to the heating of the tissue, blood flow increases, resulting in higher oxygen enrichment in the affected tissue. Another important effect is the inhibition of the cancer cells’ own DNA repair mechanisms because the heat releases heat-shock proteins. Thus, hyperthermia is probably the most effective support to radiotherapy available today. (accordion: openscale title: Why is regional deep hyperthermia suitable as a complementary treatment to chemotherapy?) Hyperthermia is normally administered in parallel with chemotherapy. Hyperthermia generally enhances the effects of chemotherapy on the tumour. The most important reason for this is that capillary vessels in the tumour tissue generally have no muscle layer (steel phenomenon) and thus are not able to expand when overheated, unlike the microvessels in adjacent healthy tissue. Since under normal temperature conditions during chemotherapy a higher blood flow occurs in the tumour tissue first, the cytostatic drugs in the tumour tissue diffuse more strongly. With the subsequent targeted hyperthermia of the tumour region and the adjacent healthy tissue, the blood flow ratio changes such that the drugs in the tumour tissue cannot be flushed out as easily, and at the same time blood perfusion in the surrounding healthy tissue is now higher and thus the cytostatic drugs can be evacuated more easily. Furthermore, the permeability of the capillary vessels in the tumour is increased by the insufficient (lack of) wall build-up under the influence of heat, thus accelerating the absorption of cytostatic drugs by the cancer cells. Thus, in some cases, previously ineffective chemotherapy can become an effective treatment thanks to hyperthermia. (accordion: openscale title: Regional hyperthermia as a complementary treatment to chemotherapy) Confirmed by the results of a new study, it has been shown that hyperthermia has a significantly stronger impact compared to pure chemotherapy (e.g. Issels 2007 for sarcomas; Jones 2007 for breast cancer, among others). The technique of regional deep hyperthermia heats up the tumour cells using high-frequency waves and affects the metabolism of the cells and the extracellular environment. This causes the cellular metabolism of the cancer cells to change locally to such an extent that programmed destruction can be induced (apoptosis). Meanwhile, it has been proven repeatedly that heating a tumour can inhibit the growth of tumour cells, shrink tumours and even result in complete healing. (accordion: openscale title: Does statutory insurance pay for Celsius TCS - Tumor Cell Solution treatment?) Since regional electro deep hyperthermia is an innovative and new form of therapy, in accordance with §12 of the German SGBV, health insurance companies are not obligated to pay for it. However, an application for reimbursement can be lodged. Following a decision by the German Federal Court of Justice (BGH) in August 2006 *, an insurance agency was ordered to cover the treatment costs in an individual case. Otherwise, the costs for regional deep hyperthermia are normally billed at the simple rate of the German scale of charges for doctors (GOÄ) (according to GOÄ Section 5854 (145.14 Euro) per treatment session). (link: http://www.bverfg.de/entscheidungen/rs20051206_1bvr034798.html text: * Link to decision „1 BvR 347/98“ popup: yes) or (file: 1_bvr_347_98.pdf text: download decision as PDF popup: yes) (accordion: openscale title: What is the essential advantage of Celsius TCS - Tumor Cell Solution compared with competitors' methods?) The Celsius TCS – Tumor Cell Solution system is equipped with two active electrodes, which sets it apart from other systems currently on the market. Our technical innovation ensures that the tumor is subject to a more homogeneous temperature development. Thanks to the various electrode sizes, the target area in the patient’s body can be heated up precisely. The various levels of impedance ("sensitivity") in the diseased and healthy tissue therefore further support the treatment focus. Tumors located deeper within the body can be treated as well. This is accomplished by a carrier frequency of 13.56 MHz, which is generally able to reach even deeper-lying regions. At the same time, the powerful high capacity generated by the intelligent technical impact and a particularly sustainable water cooling system ensure a significant penetration depth. (accordion: openscale title: Do you have any references?) We would be happy to arrange a reference visit to one of our customers on request. Just give us a call. You can find a selection of our clients under the keyword “References”. (accordion: openscale title: To what extent can Celsius TCS - Tumor Cell Solution be incorporated into an organisational structure?) Celsius TCS - Tumor Cell Solution was developed from a profound knowledge of requirements from the procedural point of view of an organisation. There is a workflow overview that can be called up rapidly to provide a clear overview of all patients undergoing active treatment. Furthermore, a medical documentation feature, which collects and stores all relevant parameters, is included. Wherever possible, data is collected by the Celsius TCS - Tumor Cell Solution modality in order to reduce user input to a minimum and to store all relevant treatment parameters. (accordion: close)


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