A new domestic radiopharmaceutical Sentiskan, 99mTc based on technetium-99m labeled alumina developed by scientists of Tomsk Polytechnic University and Oncology Research Institute of Tomsk National Research Medical Center is being supplied to medical institutions all over the country. At present, more than 1,000 vials of the new drug have been produced.
Earlier it became known that in 2022 Tomsk scientists together with the industrial partner, MedikorPharma-Ural company, had launched four new radiopharmaceuticals: for diagnostics of sentinel lymph nodes in several types of oncology diseases - brain tumors, prostate cancer and neuroendocrine tumors.
One of them, Sentiscan, is designed for radionuclide diagnostics of sentinel lymph nodes. This is the first domestic drug of this kind - until recently, Russia lacked domestic radiopharmaceuticals for visualization of sentinel lymph nodes, which stand in the way of lymphogenic metastasis of malignant tumors. So far, the domestic radiopharmaceutical Technefit, 99mTc used for this purpose is registered only for liver scintigraphy. In addition, Sentiscan is many times cheaper than imported analogues.
"Our scientific teams have spent many years studying the safety and efficacy of the radiopharmaceutical, optimizing production processes, and developing methods and instructions for medical use. Until 2020, we were scaling up and fine-tuning the production process, validating and confirming its reproducibility, and setting up quality control procedures. This resulted in obtaining a registration certificate and organizing serial production at the research nuclear reactor of Tomsk Polytechnic University," says Vladimir Chernov, deputy director of the Tomsk Oncology Research Institute of Tomsk National Research Medical Center for scientific and innovative work, head of the Healthcare Engineering Strategic Office at Tomsk Polytechnic University.
The pharmaceutical was developed under the framework of PHARMA-2020 federal target program and with the support of Priority-2030 program of the Russian Ministry of Education and Science implemented at Tomsk Polytechnic University.
"At present, Sentiscan is being delivered to medical institutions all over the country. The geography is very wide - Tomsk, Moscow, St. Petersburg, Tyumen, Vladivostok, Yuzhno-Sakhalinsk and many other cities. In 2023, 1,200 vials of the drug have already been produced," adds Elena Stasyuk, one of the developers of the drug, senior researcher at the TPU Nuclear Reactor Laboratory No. 31.
According to the scientists, it has already been proven that biopsy of a sentinel lymph node with subsequent histological or cytological examination can predict the presence of regional metastasis with high probability. The use of radionuclide diagnostics makes it possible to precisely determine the location of the sentinel node both during surgery and at the preoperative stage. As a result, functional and cosmetic postoperative defects are minimized, which preserves the patient's quality of life.
