Description of the purpose of the project and ways to achieve it
Today, nuclear medicine methods are widely used in the diagnosis and treatment of cancer. In Ukraine, the use of radionuclide diagnostics is represented in oncology by the following methods: osteoscintigraphy, lymphoscintigraphy, mammoscintigraphy, scintigraphy: brain, kidneys, thyroid and parathyroid glands, liver and biliary tract, adrenal glands and intraoperative detection of sentinel lymph nodes, positron emission tomography methods.
Positron emission tomography methods in Ukraine are used only in three clinics throughout the country (two state and one private).
Positron emission tomography / computed tomography is a highly informative method of radiation (radionuclide) diagnostics with unique capabilities for determining metabolism at the cellular and molecular levels during life. This is a nuclear medicine method, which is today considered the “gold standard” for the diagnosis of malignant neoplasms in the world, PET/CT allows for a single study to determine the stage of the disease, obtaining an image of the primary tumor, regional and distant metastases. The PET method is one of the most high-tech and informative methods of medical imaging, which are part of the group of molecular medicine methods.
Positron emission tomography has significant advantages over ultrasound diagnostics, CT, magnetic resonance imaging (MRI) and single-photon emission computed tomography (SPECT). The sensitivity of the method is twice as high as the sensitivity of SPECT. It is possible to measure functional changes in biochemical processes in the patient's body, which makes it possible to achieve high accuracy in the differential diagnosis of a benign neoplasm from a malignant neoplasm, and to assess the effectiveness of treatment in a timely manner. It is also possible to early detect metastases measuring 4–5 mm in size. The patient's entire body is scanned for the presence of a primary tumor and almost all metastases are identified in one session.
Since 2010, the All-Ukrainian Center for Radiosurgery with the use of PET technologies has been operating within the hospital structure, where the production of the radiopharmaceutical 18F-Fluorideoxyglucose for PET/CT diagnostics has been successfully established. The production and quality control laboratory comply with the international GMP standard and have a license from the State Medical Service.
Today, in the Feofania Clinical Hospital, in the radiopharmaceutical production department of the All-Ukrainian Center for Radiosurgery, the production of the only radiopharmaceutical "F18-Fluorideoxyglucose" has been established, which has the widest application in oncology. Each year, the center produces about 200 batches of the drug, in accordance with the existing license.
In 2023, the hospital introduced the production of the radiopharmaceutical for prostate cancer diagnostics F-18-PSMA-1007.
The practical implementation of the above provisions in the Feofaniya Clinical Hospital of the State Medical University allowed not only to build and organize the work of a domestic PET center, but also to examine about 4,500 patients in three years. The average load on the PET center is 1,520 combined examinations per year. The vast majority of examined patients are oncology patients (> 90%) with the following distribution by nosology: lymphoma (32.4%), breast cancer (12.2%), colorectal cancer (8.6%), lung cancer (6.6%), tumors of the female reproductive system (5.0%), melanoma (3.0%), thyroid cancer (2.6%), pancreatic cancer (2.0%), nasopharyngeal cancer (1.0%) and other localizations (26.0%).
Today, the Feofaniya Clinical Hospital is the only clinic in Ukraine that, subject to the modernization of existing, modern equipment, can produce new radiopharmaceuticals, namely: (18F)NaF, (18F)FLT, (18F)FMISO, (18F)FCHOLIN 18F-PSMA and use them to conduct diagnostic examinations of brain and prostate tumors.
Every year, more than two thousand oncological patients receive about twenty thousand procedures of highly specialized modern medical care at the All-Ukrainian Center for Radiosurgery. At the time of its establishment, the Center was equipped with the latest equipment for the production of radiopharmaceuticals, conducting PET/CT studies and conducting radiation therapy. Today, the Center remains the only certified manufacturer of sterile radiopharmaceuticals in Ukraine.
The relevance of the project is that as a result of its implementation, more patients will be able to receive timely diagnosis and treatment of oncological diseases in conditions that meet European standards.
In the event of non-implementation of the project:
taking into account the analysis of the actual state of the existing equipment of the radiopharmaceutical production department without urgent modernization of hot chambers, gas supply system and radiopharmaceutical filling module, a complete stop of production is predicted. This, in turn, will lead to the impossibility of citizens' access to high-precision diagnostic methods, which in turn will increase the population's demand for diagnosis and treatment of oncological diseases, and the clinic will not be able to fully provide treatment standards as an institution of specialized (tertiary) medical care,