Medical Radiology and Radiation Safety. 2025. Vol. 70. № 6
DOI:10.33266/1024-6177-2025-70-6-115-120
Yu.V. Varlamova1, K.D. Kurushin2, M.A. Sazonova3, Yu.N. Ilyushenkova1,
S.I. Sazonova1
Experience for Assessing the Radiochemical Purity
of Radiopharmaceutical 99mTc-MIBI in the Radionuclide Diagnostics Department
1 Cardiology Research Institute, Tomsk NRMC, Tomsk, Russia
2 Siberian State Medical University, Tomsk, Russia;
3 Tomsk Polytechnic University Lyceum , Tomsk, Russia
Contact person: Yu.V. Varlamova, e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
ABSTRACT
Purpose: To analyze the accumulated experience and compare the results of radiochemical purity (RCP) assessment of the 99mTc-MIBI with the quality of myocardial perfusion images (MPI).
Material and methods: From October 2023 to March 2025, a total of 1,163 RCP analyses of ⁹⁹ᵐTc-MIBI were conducted using thin-layer chromatography (TLC) in the Department of Nuclear Medicine of the Cardiology Research Institute, Tomsk NRMC. Intra- and inter-operator reproducibility of TLC results were evaluated using the intraclass correlation coefficient (ICC, 95 % CI). The retrospective study included 100 patients who underwent myocardial perfusion imaging. Diagnostic image quality was independently assessed by two radiologist using both visual evaluation and quantitative analysis (heart-to-liver ratio). Spearman’s correlation coefficient was used to compare TLC results with scintigraphic image quality.
Results: The average content of radiochemical impurities (RCI) in ⁹⁹ᵐTc-MIBI was 9.8 ± 9.95 %. The TLC demonstrated acceptable reproducibility both within and between operators, with intra- and inter-operator ICC values of 0.537 (95 % CI: 0.131–0.790) and 0.786 (95 % CI: 0.376–0.941), respectively. A significant decreasing of the heart-to-liver ratio was observed with increasing of RCI levels: for RCI <10 % – 0.93 (0.79–1.07); for RCI 10–15 % – 0.65 (0.49–0.82); and for RCI 15–20 % – 0.51 (0.46–0.72). In 15 % of cases, the myocardial perfusion images were non-diagnostic, predominantly when RCI exceeded 15 %. Statistically significant indirect correlation between RCI levels and the heart-to-liver ratio (r = –0.581, p = 0.0001), as well as between RCI levels and the visual quality of myocardial perfusion images (r = –0.504, p = 0.0001) was found.
Conclusion: The radiochemical purity of ⁹⁹ᵐTc-MIBI has a direct impact on the diagnostic quality of myocardial perfusion images. For clinical use, the recommended threshold for radiochemical impurities in this radiopharmaceutical should not exceed 15 % (i.e., RCP ≥ 85 %).
Keywords: 99mTc-MIBI, radiochemical purity, thin-layer chromatography, myocardial perfusion scintigraphy
For citation: Varlamova YuV, Kurushin KD, Sazonova MA, Ilyushenkova YuN, Sazonova SI. Experience for Assessing the Radiochemical Purity of Radiopharmaceutical 99mTc-MIBI in the Radionuclide Diagnostics Department. Medical Radiology and Radiation Safety. 2025;70(6):115–120. (In Russian). DOI:10.33266/1024-6177-2025-70-6-115-120
References
1. Vrints C., Andreotti F., Koskinas K.C., Rossello X., Adamo M., Ainslie J., Banning A.P., Budaj A., Buechel R.R., Chiariello G.A., Chieffo A., Christodorescu R.M., Deaton C., Doenst T., Jones H.W., Kunadian V., Mehilli J., Milojevic M., Piek J.J., Pugliese F., Rubboli A., Semb A.G., Senior R., Ten Berg J.M., Van Belle E., Van Craenenbroeck E.M., Vidal-Perez R., Winther S. ESC Scientific Document Group. 2024 ESC Guidelines for the Management of Chronic Coronary Syndromes. Eur Heart J. 2024 Sep 29;45;36:3415-3537. doi: 10.1093/eurheartj/ehae177. Erratum in: Eur Heart J. 2025 Apr 22;46;16:1565. doi: 10.1093/eurheartj/ehaf079.
2. Nunn A.D. Radiopharmaceuticals for Imaging Myocardial Perfusion. Semin Nucl Med. 1990;20;2:111-8. doi: 10.1016/s0001-2998(05)80164-3.
3. Kelly J.D., Forster A.M., Higley B., Archer C.M., Booker F.S., Canning L.R., Chiu K.W., Edwards B., Gill H.K., McPartlin M., et al. Technetium-99m-Tetrofosmin as a new Radiopharmaceutical for Myocardial Perfusion Imaging. J Nucl Med. 1993 Feb;34;2:222-7.
4. Лишманов Ю.Б., Завадовский К.В., Ефимова И.Ю., Кривоногов Н.Г., Ефимова И.Ю., Веснина Ж.В., Сазонова С.И., Саушкина Ю.В., Саушкин В.В., Ильюшенкова Ю.Н., Гуля М.О., Пешкин Я.А., Мочула А.В. Возможности ядерной медицины в диагностике сердечно-сосудистых заболеваний // Сибирский журнал клинической и экспериментальной медицины. 2015. Т.30. №2. С. 21-29 [Lishmanov Yu.B., Zavadovskiy K.V., Yefimova I.Yu., Krivonogov N.G., Yefimova I.Yu., Vesnina Zh.V., Sazonova S.I., Saushkina Yu.V., Saushkin V.V., Il’yushenkova Yu.N., Gulya M.O., Peshkin Ya.A., Mochula A.V. Potential of Nuclear Medicine in Diagnostics of Cardiovascular Diseases. Sibirskiy Zhurnal Klinicheskoy i Eksperimental’noy Meditsiny = The Siberian Journal of Clinical and Experimental Medicine. 2015;30;2:21-29 (In Russ.)]. doi: 10.29001/2073-8552-2015-30-2-21-29.
5. Практическое руководство по сцинтиграфии сердца / Под ред. Ю.Б. Лишманова, К.В. Завадовского. Томск: Издательство НТЛ, 2018. 168 с. [Prakticheskoye Rukovodstvo po Stsintigrafii Serdtsa = Practical Guide to Cardiac Scintigraphy. Ed. Yu.B. Lishmanov, K.V. Zavadovskiy. Tomsk, NTL Publ., 2018. 168 p. (In Russ.)]. ISBN 978-5-6040497-4-7, 978-5-89503-622-8
6. Ларенков А.А., Кодина Г.Е., Малышева А.О. Практическое руководство по контролю качества радиофармацевтических препаратов на основе генераторов технеция-99m и рения-188: Учебное пособие: М.: Государственный научный центр Российской Федерации - Федеральный медицинский биофизический центр имени А.И. Бурназяна, 2022. 104 с. [Larenkov A.A., Kodina G.Ye., Malysheva A.O. Prakticheskoye Rukovodstvo po Kontrolyu Kachestva Radiofarmatsevticheskikh Preparatov na Osnove Generatorov Tekhnetsiya-99m i Reniya-188 = Practical Guide to Quality Control of Radiopharmaceuticals Based on Technetium-99m and Rhenium-188 Generators. Tutorial, Moscow, Federal’nyy Meditsinskiy Biofizicheskiy Tsentr Im. A.I. Burnazyana Publ., 2022. 104 p. (In Russ.)]. ISBN 978-5-95064-206-3
7. EANM. Draft Guidelines for Radiopharmacy. Eur J Nucl Med Mol Imaging. 2003 Aug;30;8:BP63-72. doi: 10.1007/s00259-003-1291-1.
8. Zolle I. Technetium-99m Pharmaceuticals: Preparation and Quality Control in Nuclear Medicine. Berlin, Heidelberg, Springer, 2007. 345 p. doi: 10.1007/978-3-540-33990-8.
9. Santos P. A. de L. Evaluation of the Quality of the Radiopharmaceutical 99mTc-MIBI and its Influence on the Image Quality in Myocardial Perfusion Scintigraphy. Abstract of Doctor’s Thesis. Recife: Universidade Federal de Pernambuco, 2013. 92 p.
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Conflict of interest. The authors declare no conflict of interest.
Financing. The study had no sponsorship.
Contribution. Article was prepared with equal participation of the authors.
Article received: 20.07.2025. Accepted for publication: 25.08.2025.