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Studies of a radioactive product for treatment of peritoneal cancer

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The objective of the animal studies described in this project is to investigate a newly developed radiation treatment against cancers that spread to the peritoneal cavity (Radspherin). For this purpose, we will need to examine the toxicity, pharmacokinetics, biodistribution and therapeutic efficacy of the treatment alone or in combination with other relevant therapeutic agents for peritoneal cancers. All experiments in this study are performed with the purpose of finding the best treatment option for patients with peritoneal metastases while simultaneously gathering pre-clinical data needed for applications for clinical trials.
We have requested a total of 830 mice (550 athymic nude and 280 Balb/c) to accomplish our research objectives. The expected adverse effects on the animals will mainly be related to tumor growth (relevant for 400 mice), but possible adverse effects can also arise as a result of treatment related toxicities (relevant for 420 mice). The number of animals has been reduced as much as possible by using results from in vitro and pilot animal experiments together with a thorough assessment of experimental groups and group sizes by statistical analyses. Our experience with this type of cancer models and therapy has given the participants in the study valuable experience in early recognition of symptoms of disease and has refined our selection of study specific humane end points. Experience with the radionuclide and the cancer models used also ensures that the time frame for treatment related toxicity and onset of the disease is known, allowing for extra careful monitoring of the animals in this period. We always aim to carry out our studies causing minimal pain and distress for the mice and we are continuously working to refine our methods to improve animal welfare.