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

O. Bragina, M.E. Borodina, V. Chernov, S. Deyev, M. A. Vostrikova, A.A. Romanova
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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.
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乳腺癌患者体内 99m锝(CO)3-(HE)3-DARPinG3 的急性毒性评估
目的:研究放射性药物[99mTc]Tc-(HE)3-G3 在乳腺癌患者中的急性毒性。材料与方法:研究纳入了 10 例乳腺癌患者(T1-4N0-2M0),这些患者在接受全身/手术治疗前均有不同的 HER2/neu 表达,他们均注射了 1000 μg 标记有锝-99m 的 DARPinG3 蛋白([99mTc]Tc-(HE)3-G3)。在整个研究过程(48 小时)中,医护人员对患者进行监测,评估患者的主诉,在注射放射性药物前以及注射后 2、4、6、24 和 48 小时测量心率、血压和体温。此外,还在注射前、48 小时后和 7 天后进行了化验,如一般和生化血液化验以及一般尿液分析。结果显示研究中的乳腺癌患者在注射放射性药物[99mTc]Tc-(HE)3-G3 时、注射后 2、4、6、24、48 小时和 7 天内均未出现不适症状,也未发现不良反应。心率、体温和血压的测量也未显示出病理异常。根据一般血液生化分析、一般尿液分析和心电图结果,注射放射性药物[99mTc]Tc-(HE)3-G3 后 2、4、6、24、48 小时和 7 天均未发现异常。结论已完成的研究充分证明,临床使用放射性药物 [99mTc]Tc-(HE)3-G3 对乳腺癌患者进行放射性核素诊断是安全的。直接参与分析的患者的主观感觉和注射放射性药物[99mTc]Tc-(HE)3-G3 前以及注射后 2、4、6、24 和 48 小时的临床定量参数数据均证实了所获得的数据。
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来源期刊
Medical Radiology and Radiation Safety
Medical Radiology and Radiation Safety Medicine-Radiology, Nuclear Medicine and Imaging
CiteScore
0.40
自引率
0.00%
发文量
72
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