Introduction of 99mTc-Tectrotyd labeling and quality control method, radiopharmaceutical for visualisation of neuroendocrine tumors

This dissertation is focused in the introduction of a new preparation for visualization of neuroendocrine tumors, 99mTc-Tectrotyd in the department of Nuclear Medicine in Pristina and standardization and validation of quality control procedures. In order to achieve high specific binding and safety after application of this relatively new radiopharmaceutical, it is necessary to ensure proper quality control, which will guarantee the same. This was a reason to standardize quality control methods and suggest the most appropriate ones. Neuroendocrine tumors (NETs) are tumors of a heterogeneous group of epithelial neoplasms originating from cells of the APUD system (DNES cells - a group of seemingly unrelated endocrine cells) and can be located in different organs - hypothalamus, pituitary, thyroid and thyroid gland gastrointestinal tract. They grow slowly and are therefore not easy to detect. Radioactive peptides are the future of imaging and therapy for neuroendocrine tumors because they are specific and have a receptor-ligand interaction. They have greater stability because the changes are not natural and there is a change in the order of the amino acids. They can be one of the basic molecules that as radioactively labeled can be used for diagnostic and therapeutic purposes. Visualization procedures for the diagnosis of neuroendocrine tumors (NETs) are somatostatin receptor PET / CT or scintigraphy with somatostatin analogues. The presence of mechanisms for acceptance of neuraminic and / or peptide receptors on the cell membrane in these tumors allows the clinical use of specific radiopharmaceuticals for diagnosis and therapy (teranostics). The studies were conducted in the Department of Nuclear Medicine (HUCSK) in Pristina in cooperation with the Department of Nuclear Medicine, Oncology Hospital Sofia, Bulgaria, where the pilot project was developed. The realization of this study is based on the idea of how to contribute to having a good safe new radiopharmaceutical product, using a radiopharmaceutical kit, of HYNIC-D-Phe1, Tyr3-Octreotide giving it as 99mTc-HYNIC-TOC. 99mTc-Tektrotyd is a radiopharmaceutical for diagnostic use only. It is a radiopharmaceutical indicated for the diagnosis of pathological lesions in which somatostatin receptors are overexpressed (especially subtypes 2 and, to a lesser extent, subtypes 3 and 5) and which can be visualized with it. The physical characteristics of 99mTc are more appropriate for camera, which has lower radiation to the patient and provides better image quality with lower radiation doses. Through my doctoral thesis prepared in the department of Nuclear Medicine in Prishtina, for the first time Tectrotyd was used for visualization of neuroendocrine tumors, their detection and evaluation of the success of the used therapy. The preparation will be introduced as a new method in the department of Nuclear Medicine in the Clinical and University Service of Kosovo in Prishtina. The conditions in the renovated and equipped laboratory for radiopharmacy have all the conditions for preparation of this radiopharmaceutical. This dissertation presents the importance of using radiopharmaceuticals marked with technetium-99m in institutions where there is no positron emission tomography. As there is no monograph in the European Pharmacopoeia, the quality control method should be validated according to the manufacturer's recommendations. The examinations will be performed using the whole-body technique and SPECT of the selected body parts