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. 2024. Vol. 69. № 3

DOI:10.33266/1024-6177-2024-69-3-72-76

O.D. Bragina1, 2, M.E. Borodina4, V.I. Chernov1, 2, S.M. Deyev2, 3,
M.A. Vostrikova1, A.A. Romanova1

Assessment of Acute Toxicity of the 99mTc(CO)3-(HE)3-DARPinG3 in Breast Cancer Patients

1 National Research Medical Center, Tomsk, Russian

2 Research Center “Oncotheranostics”, National Research Tomsk Polytechnic University, Tomsk, Russia

3 M.M. Shemyakin & Yu.A. Ovchinnikov Institute of Bioorganic Chemistry, Moscow, Russia

4 National Medical Research Radiological Centre, Moscow, Russia

Contact person: O.D. Bragina, e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

ABSTRACT

Purpose: Study the acute toxicity of the radiopharmaceutical [99mTc]Tc-(HE)3-G3 in breast cancer patients.

Material and Methods: The study included 10 breast cancer patients (T1-4N0-2M0) with different HER2/neu expression before systemic/surgical treatment, who were injected with 1000 μg of DARPinG3 protein labeled with technetium-99m ([99mTc]Tc-(HE)3-G3). Throughout the study (48 hours), patients were monitored by medical personnel, during which complaints were assessed, heart rate, blood pressure and body temperature were measured before injection of the radiopharmaceutical, as well as 2, 4, 6, 24 and 48 hours after injection. Additionally, laboratory tests such as general and biochemical blood tests and general urine analysis were performed before injection, 48 hours and 7 days later.

Results: The presence of complaints, as well as the detection of adverse reactions in breast cancer patients included in the study at the time of injection of the radiopharmaceutical [99mTc]Tc-(HE)3-G3, as well as 2, 4, 6, 24, 48 hours and 7 days after injection were not detected. The measurement of heart rate, body temperature, and blood pressure also showed no pathological abnormalities. According to general and biochemical blood analysis, general urine analysis and ECG results, no abnormalities were found 2, 4, 6, 24 and 48 hours, as well as 7 days after of the radiopharmaceutical [99mTc]Tc-(HE)3-G3.

Conclusion: The performed studies fully demonstrate the safety of the clinical use of the radiopharmaceutical [99mTc]Tc-(HE)3-G3 for radionuclide diagnosis of breast cancer patients. The data obtained were confirmed both by the subjective sensations of the patients directly included in the analysis, and by the data of clinical quantitative parameters before the start, as well as 2, 4, 6, 24 and 48 hours after injection of the radiopharmaceutical [99mTc]Tc-(HE)3-G3.

Keywords: radionuclide diagnostics, scaffold proteins, 99mTc-DARPinG3, breast cancer, HER2/neu

For citation: Bragina OD, Borodina ME, Chernov VI, Deyev SM, Vostrikova MA, Romanova AA. Assessment of Acute Toxicity of the 99mTc(CO)3-(HE)3-DARPinG3 in Breast Cancer Patients. Medical Radiology and Radiation Safety. 2024;69(3):72–76. (In Russian). DOI:10.33266/1024-6177-2024-69-3-72-76

 

References

1. Bragina O, Deyev SM, Chernov VI, Tolmachev VM. The Evolution of Targeted Radionuclide Diagnosis of HER2-Positive Breast Cancer Acta Naturae. 2022;Apr-Jun;14(2):4–15. DOI: 10.32607/actanaturae.11611. PMID:35923562.

2. Hricak H, Abdel-Wahab M, Atun R, Lette MM, Paez D, Brink JA, Donoso-Bach L, Frija G, Hierath M, Holmberg O, Khong PL, Lewis JS, McGinty G, Oyen WJG, Shulman LN, Ward ZJ, Scott AM. Medical Imaging and Nuclear Medicine: a Lancet Oncology Commission. Lancet Oncol. 2021;Apr;22(4):136-172. DOI: 10.1016/S1470-2045(20)30751-8. PMID: 33676609.

3. Bodei L, Herrmann K, Schöder H, Scott AM, Lewis JS. Radiotheranostics in Oncology: Current Challenges and Emerging Opportunities. Nat Rev Clin Oncol. 2022;Aug;19(8):534-550. DOI: 10.1038/s41571-022-00652-y. PMID: 35725926.

4. Giordano SH, Franzoi MAB, Temin S, Anders CK, Chandarlapaty S, Crews JR, Kirshner JJ, Krop IE, Lin NU, Morikawa A, Patt DA, Perlmutter J, Ramakrishna N, Davidson NE. Systemic Therapy for Advanced Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: ASCO Guideline Update. J Clin Oncol. 2022;Aug 10;40(23):2612-2635. DOI: 10.1200/JCO.22.00519. PMID: 35640077.

5. Wolff AC, Hammond ME, Hicks DG, Dowsett M, McShane LM, Allison KH, Allred DC, Bartlett JM, Bilous M, Fitzgibbons P, Hanna W, Jenkins RB, Mangu PB, Paik S, Perez EA, Press MF, Spears PA, Vance GH, Viale G, Hayes DF. Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology. College of American Pathologists Clinical Practice Guideline Update. J Clin Oncol. 2013;31:3997-4013. DOI: 10.1200/JCO.2013.50.9984. PMID: 24101045.

6. Tolmachev V, Orlova A, Sorensen J. The Emerging Role of Radionuclide Molecular Imaging of Her2 Expression in Breast Cancer. Semin Cancer Biol. 2021;72:185-197. DOI: 10.1016/j.semcancer.2020.10.005. PMID: 33465471.

7. Брагина О.Д., Чернов В.И., Гарбуков Е.Ю., Дорошенко А.В., Воробьева А.Г., Орлова А.М., Толмачев В.М. 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. https://doi.org: 10.20538/1682-0363-2021-1-23-30. [Bragina OD, Chernov VI, Garbukov EYu, Doroshenko AV, Vorobyeva AG, Orlova AM, Tolmachev VM. Possibilities of Radionuclide Diagnostics of Her2-Positive Breast Cancer Using Technetium-99m-Labeled Target Molecules: the First Experience of Clinical Use. Bulletin of Siberian Medicine. 2021;20(1):23–30. https://doi.org: 10.20538/1682-0363-2021-1-23-30. (In Russ.)].

8. Tolmachev V, Bodenko V, Oroujeni M, Deyev S, Konovalova E, Schulga AS, Hober S, Bragina OA, Vorobyeva A. Direct in Vivo Comparison of 99mTc-Labeled Scaffold Proteins DARPin G3 and ADAPT6 for Visualization of HER2 Expression and Monitoring of Early Response for Trastuzumab Therapy. International Journal of Molecular Sciences. 2022;Dec;2;23(23):15181. DOI: 10.3390/ijms232315181. PMID: 36499504.

9. Bragina O, Chernov V, Schulga A, Konovalova E, Hober S, Deyev S, Sörensen J, Tolmachev V. Direct Intra-Patient Comparison of Scaffold Protein-Based Tracers, [99mTc]Tc ADAPT6 and [99mTc]Tc-(HE)3-G3, for Imaging of HER2-Positive Breast Cancer. Cancers. 2023;15(12):3149. https://doi.org/10.3390/cancers15123149.

10. Bragina O, von Witting E, Garousi J, Zelchan R, Sandström M, Orlova A, Medvedeva A, Doroshenko A, Vorobyeva A, Lindbo S, Borin J, Tarabanovskaya N, Sörensen J, Hober S, Chernov V, Tolmachev V. Phase I Study of 99mTc-ADAPT6, a Scaffold Protein-Based Probe for Visualization of HER2 Expression in Breast Cancer. J Nucl Med. 2021;Apr;62(4):493-499. DOI: 10.2967/jnumed.120.248799. PMID: 32817142.

11. Bragina O, Chernov V, Larkina M, Rybina A, Zelchan R, Garbukov E, Oroujeni M, Loftenius A, Orlova A, Sörensen J, Frejd FY, Tolmachev V. Phase I Clinical Evaluation of 99mTc-labeled Affibody Molecule for Imaging HER2 Expression in Breast Cancer. Theranostics. 2023;Sep;4;13(14):4858-4871. DOI: 10.7150/thno.86770. PMID: 37771776.

 

 

 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. Article was prepared with equal participation of the authors.

Article received: 20.01.2024. Accepted for publication: 27.02.2024.

 

 

 

 

 

 

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