JOURNAL DESCRIPTION
The Medical Radiology and Radiation Safety journal ISSN 1024-6177 was founded in January 1956 (before December 30, 1993 it was entitled Medical Radiology, ISSN 0025-8334). In 2018, the journal received Online ISSN: 2618-9615 and was registered as an electronic online publication in Roskomnadzor on March 29, 2018. It publishes original research articles which cover questions of radiobiology, radiation medicine, radiation safety, radiation therapy, nuclear medicine and scientific reviews. In general the journal has more than 30 headings and it is of interest for specialists working in thefields of medicine¸ radiation biology, epidemiology, medical physics and technology. Since July 01, 2008 the journal has been published by State Research Center - Burnasyan Federal Medical Biophysical Center of Federal Medical Biological Agency. The founder from 1956 to the present time is the Ministry of Health of the Russian Federation, and from 2008 to the present time is the Federal Medical Biological Agency.
Members of the editorial board are scientists specializing in the field of radiation biology and medicine, radiation protection, radiation epidemiology, radiation oncology, radiation diagnostics and therapy, nuclear medicine and medical physics. The editorial board consists of academicians (members of the Russian Academy of Science (RAS)), the full member of Academy of Medical Sciences of the Republic of Armenia, corresponding members of the RAS, Doctors of Medicine, professor, candidates and doctors of biological, physical mathematics and engineering sciences. The editorial board is constantly replenished by experts who work in the CIS and foreign countries.
Six issues of the journal are published per year, the volume is 13.5 conventional printed sheets, 88 printer’s sheets, 1.000 copies. The journal has an identical full-text electronic version, which, simultaneously with the printed version and color drawings, is posted on the sites of the Scientific Electronic Library (SEL) and the journal's website. The journal is distributed through the Rospechat Agency under the contract № 7407 of June 16, 2006, through individual buyers and commercial structures. The publication of articles is free.
The journal is included in the List of Russian Reviewed Scientific Journals of the Higher Attestation Commission. Since 2008 the journal has been available on the Internet and indexed in the RISC database which is placed on Web of Science. Since February 2nd, 2018, the journal "Medical Radiology and Radiation Safety" has been indexed in the SCOPUS abstract and citation database.
Brief electronic versions of the Journal have been publicly available since 2005 on the website of the Medical Radiology and Radiation Safety Journal: http://www.medradiol.ru. Since 2011, all issues of the journal as a whole are publicly available, and since 2016 - full-text versions of scientific articles. Since 2005, subscribers can purchase full versions of other articles of any issue only through the National Electronic Library. The editor of the Medical Radiology and Radiation Safety Journal in accordance with the National Electronic Library agreement has been providing the Library with all its production since 2005 until now.
The main working language of the journal is Russian, an additional language is English, which is used to write titles of articles, information about authors, annotations, key words, a list of literature.
Since 2017 the journal Medical Radiology and Radiation Safety has switched to digital identification of publications, assigning to each article the identifier of the digital object (DOI), which greatly accelerated the search for the location of the article on the Internet. In future it is planned to publish the English-language version of the journal Medical Radiology and Radiation Safety for its development. In order to obtain information about the publication activity of the journal in March 2015, a counter of readers' references to the materials posted on the site from 2005 to the present which is placed on the journal's website. During 2015 - 2016 years on average there were no more than 100-170 handlings per day. Publication of a number of articles, as well as electronic versions of profile monographs and collections in the public domain, dramatically increased the number of handlings to the journal's website to 500 - 800 per day, and the total number of visits to the site at the end of 2017 was more than 230.000.
The two-year impact factor of RISC, according to data for 2017, was 0.439, taking into account citation from all sources - 0.570, and the five-year impact factor of RISC - 0.352.
Medical Radiology and Radiation Safety. 2026. Vol. 71. № 1
DOI:10.33266/1024-6177-2026-71-1-33-38
O.D. Bragina1,2, A.G. Ivanova1, M.S. Larkina2, 3, R.N. Varvashenya2, 3,
M.A. Vostrikova1, N.O. Popova1, V.E. Goldberg1, V.I. Chernov1, 2, S.V. Patalyak1
Evaluation of the Safety and Pharmacokinetic Analysis
of the Radiopharmaceutical [99mTc]Tc-DB8 in Breast Cancer Patients
1 Tomsk National Research Medical Center, Tomsk, Russia
2 National Research Tomsk Polytechnic University, Tomsk, Russia
3 Siberian State Medical University, Tomsk, Russia
Contact person: A.G. Ivanova, e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
ABSTRACT
Purpose: To evaluate the safety and pharmacokinetics of the radiopharmaceutical agent [99mTc]Tc-DB8 in patients with breast cancer.
Material and methods: The study included 15 patients diagnosed with breast cancer (T2‒4 N0‒3 M0‒1) prior to any systemic or local treatment. Patients were divided into three groups based on the administered protein dose: 40 µg, 80 µg, and 120 µg (5 patients per group). Throughout the study, participants were under continuous clinical observation, which included assessment of symptoms, measurement of blood pressure (BP), body temperature, and heart rate prior to injection, and at 2, 4, 6, 24, and 48 hours post-injection. Additionally, complete blood count, biochemical blood analysis, and electrocardiography were performed before the injection, and again at 24 and 48 hours post-administration.
To assess the elimination rate of [99mTc]Tc-DB8 from the bloodstream, its distribution in organs and tissues, and the associated radiation dose, whole-body planar scintigraphy was conducted at 2, 4, 6, and 24 hours after radiopharmaceutical administration at doses of 40, 80, and 120 µg. The average administered activity was 334 ± 84 MBq, with a radiochemical purity exceeding 95 %.
Results: Injection of [99mTc]Tc-DB8 was not associated with any reported complaints or clinically significant changes in blood pressure, heart rate, or body temperature at any of the time points, regardless of dose. No significant deviations were observed in complete blood count, biochemical parameters, urinalysis, or ECG prior to injection, or at 48 hours and 7 days post-administration. The elimination half-life was 2.363 h for the 40 µg and 80 µg doses, and 2.233 h for the 120 µg dose. The highest absorbed doses were recorded in the mammary glands, kidneys, adrenal glands, pancreas, thyroid gland, urinary bladder and ovaries. The effective dose was 0.009 ± 0.001 mSv/MBq for the 40 µg dose, 0.011 ± 0.004 mSv/MBq for the 80 µg dose, and 0.014 ± 0.003 mSv/MBq for the 120 µg dose.
Conclusion: The drug is safe at all stages of dynamic follow-up, which is confirmed by the subjective feelings of breast cancer patients and the absence of pathological changes according to laboratory and instrumental studies, which allows the continuation of the next stages of clinical trials. Similarly, [99mTc]Tc-DB8 demonstrated rapid elimination from the bloodstream when using 40, 80 and 120 micrograms of protein, and the highest absorption was recorded in the mammary gland, kidneys, adrenal glands, pancreas, thyroid, bladder and ovaries. Based on the results of the completed analysis, the use of the drug [99mTc]Tc-DB8 served as the basis for further studies.
Keywords: target radionuclide diagnostics, luminal breast cancer, 99mTc-DB-8
For citation: Bragina OD, Ivanova AG, Larkina MS, Varvashenya RN,Vostrikova MA, Popova NO, Goldberg VE, Chernov VI, Patalyak SV. Evaluation of the Safety and Pharmacokinetic Analysis of the Radiopharmaceutical [99mTc]Tc-DB8 in Breast Cancer Patients. Medical Radiology and Radiation Safety. 2026;71(1):33–38. (In Russian). DOI:10.33266/1024-6177-2026-71-1-33-38
References
1. Siegel R.L., Miller K.D., Fuchs H.E., Jemal A. Cancer Statistics. CA Cancer J Clin. 2022;72;1:7–33. Doi: 10.3322/caac.21708.
2. Kay C., Martinez-Perez C., Dixon J.M., Turnbull A.K. The Role of Nodes and Nodal Assessment in Diagnosis, Treatment and Prediction in ER+, Node-Positive Breast Cancer. J Pers Med. 2023;13;10:1476. Doi: 10.3390/jpm13101476.
3. Verheuvel N.C., van den Hoven I., Ooms H.W.A, Voogd A.C., Roumen R.M.H. The Role of Ultrasound-Guided Lymph Node Biopsy in Axillary Staging Of Invasive Breast Cancer in the Post-ACOSOG Z0011 Trial Era. Ann Surg Oncol. 2014;21:409–415. Doi: 10.1245/s10434-014-4071-1.
4. Keelan S., Heeney A., Downey E., Hegarty A., Roche T., Power C., et al. Breast Cancer Patients with a Negative Axillary Ultrasound may have Clinically Significant Nodal Metastasis. Breast Cancer Res Treat. 2021;187;2:303–310. Doi: 10.1007/s10549-021-06194-8.
5. Aurilio G., Disalvatore D., Pruneri G., Bagnardi V., Viale G., Curigliano G., et al. A Meta-Analysis of Oestrogen Receptor, Progesterone Receptor and HER2 Discordance between Primary Breast Cancer and Metastases. Eur J Cancer. 2014;50;2):277–289. Doi: 10.1016/j.ejca.2013.10.004.
6. Schrijver W.A.M.E., Suijkerbuijk K.P.M., van Gils C.H., van der Wall E., Moelans C.B., van Diest P.J. Receptor Conversion in Distant Breast Cancer Metastases: a Systematic Review and Meta-Analysis. J Natl Cancer Inst. 2018;110;6:568–580. Doi: 10.1093/jnci/djx273.
7. Pan H., Gray R., Braybrooke J., Davies C., Taylor C., McGale P., et al. 20-Year Risks of Breast-Cancer Recurrence after Stopping Endocrine Therapy at 5 Years. N Engl J Med. 2017;377;19:1836–1846. Doi: 10.1056/NEJMoa1701830.
8. Yuan J., Yang L., Li Z., Zhang H., Wang Q., Huang J., et al. The Role of the Tumor Microenvironment in Endocrine Therapy Resistance in Hormone Receptor-Positive Breast Cancer. Front Endocrinol. 2023;14:1261283. Doi: 10.3389/fendo.2023.1261283.
9. D’Onofrio A., Engelbrecht S., Läppchen T., Rominger A., Gourni E. GRPR-Targeting Radiotheranostics for Breast Cancer Management. Front Med. 2023;10:1250799. Doi: 10.3389/fmed.2023.1250799.
10. Брагина О.Д., Иванова А.Г., Усынин Е.А. Радионуклидная визуализация GRPR при злокачественной патологии молочной и предстательной желез: опыт клинического применения // Бюллетень сибирской медицины. 2025. Т.24. №1. С. 164–172. [Bragina O.D., Ivanova A.G., Usynin Ye.A.. Radionuclide Visualization of GRPR in Malignant Pathology of the Mammary and Prostate Glands: Experience of Clinical Application. Byulleten’ Sibirskoy Meditsiny = Bulletin of Siberian Medicine. 2025;24;1:164–172 (In Russ.)]. Doi: 10.20538/1682-0363-2025-1-164-172.
11. Брагина О.Д., Деев С.М., Чернов В.И., Толмачев В.М. Эволюция таргетной радионуклидной диагностики HER2-позитивного рака молочной железы // Acta Naturae. 2022. Т.14. №2. С. 4–15 [Bragina O.D., Deyev S.M., Chernov V.I., Tolmachev V.M. Evolution of Targeted Radionuclide Imaging for HER2-Positive Breast Cancer. Acta Naturae. 2022;14;2:4–15 (In Russ.)]. Doi: 10.32607/actanaturae.11611.
12. Bragina O.D., Tashireva L.A., Loos D.M., Chernov V.I., Hober S., Tolmachev V.M. Evaluation of Approaches for the Assessment of HER2 Expression in Breast Cancer by Radionuclide Imaging Using the Scaffold Protein [99mTc]Tc-ADAPT6. Pharmaceutics. 2024;16;4:445. Doi: 10.3390/pharmaceutics16040445.
13. D’Onofrio A., Silva F., Gano L., Raposinho P., Fernandes C., Sikora A., et al. Bioorthogonal Chemistry Approach for the Theranostics of GRPR-Expressing Cancers. Pharmaceutics. 2022;14;12:2569. Doi: 10.3390/pharmaceutics14122569.
14. Vorster M., Hadebe B.P., Sathekge M.M. Theranostics in Breast Cancer. Front Nucl Med. 2023;3:1236565. Doi: 10.3389/fnume.2023.1236565.
15. Chernov V., Rybina A., Zelchan R., Medvedeva A., Bragina O., Lushnikova N., et al. Phase I Trial of [99mTc]Tc-maSSS-PEG2-RM26, a Bombesin Analogue Antagonistic to Gastrin-Releasing Peptide Receptors (GRPRs), for SPECT Imaging of GRPR Expression in Malignant Tumors. Cancers. 2023;15;6:1631. Doi: 10.3390/cancers15061631.
16. Bragina O., Chernov V., Larkina M., Rybina A., Zelchan R., Garbukov E., et al. Phase I Clinical Evaluation of 99mTc-labeled Affibody Molecule for Imaging HER2 Expression in Breast Cancer. Theranostics 2023;13;14:4858-4871. Doi: 10.7150/thno.86770.
17. Брагина О.Д., Чернов В.И., Гарбуков Е.Ю., Дорошенко А.В., Воробьева А.Г., Орлова А.М. и др. Возможности радионуклидной диагностики Her2-позитивного рака молочной железы с использованием меченных технецием-99m таргетных молекул: первый опыт клинического применения // Бюллетень сибирской медицины. 2021. Т.20. №1.
С. 23-30. [Bragina O.D., Chernov V.I., Garbukov Ye.Yu., Doroshenko A.V., Vorob’yeva A.G., Orlova A.M., et al. Possibilities of Radionuclide Diagnostics of Her2-Positive Breast Cancer using Technetium-99m-Labeled Target Molecules: First Experience of Clinical Application. Byulleten’ Sibirskoy Meditsiny = Bulletin of Siberian Medicine. 2021;20;1:23-30 (In Russ.)]. Doi: 10.20538/1682-0363-2021-1-23-30.
PDF (RUS) Full-text article (in Russian)
Conflict of interest. The authors declare no conflict of interest.
Financing. The work was carried out within the framework of the Russian Science Foundation grant No. 22-15-00169 on the topic “Phenotype of BRCA-like tumors in the process of carcinogenesis and treatment”.
Contribution. O.D. Bragina – development of the study concept and design, data analysis and interpretation, discussion of the manuscript, and checking the critical intellectual content. A.G. Ivanova – data analysis and interpretation, discussion of the manuscript, and checking the critical intellectual content. M.S. Larkina ‒ data analysis and interpretation, discussion of the manuscript, and checking the critical intellectual content. R.N. Varvashenya – data analysis and interpretation, discussion of the manuscript, and checking the critical intellectual content. M.A. Vostrikova – data collection and processing. N.O. Popova ‒ data collection and processing. V.E. Goldberg ‒ data collection and processing. V.I. Chernov – development of the study concept and design, data analysis and interpretation, discussion of the manuscript, and checking the critical intellectual content. S.V. Patalyak ‒ data collection and processing.
Article received: 20.11.2025. Accepted for publication: 25.12.2025.