METHOD FOR EVALUATING NEOADJUVANT CHEMOTHERAPY IN BREAST CANCER PATIENTS WITH HER2/NEU OVEREXPRESSION Russian patent published in 2022 - IPC A61B6/03 

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to oncology, in particular to radionuclide diagnostics, and can be used to evaluate neoadjuvant therapy of breast cancer with HER2/neu overexpression. The method includes intravenous administration of a radiopharmaceutical (RP) and scintigraphic examination. RP is administered on the basis of technetium-99m labeled recombinant targeted DARPinG3 molecules at a dose of 3000 mcg with an activity of 200-500 MBq, which is prepared immediately before administration under aseptic conditions according to laboratory regulations: 1000 mcl of ^99mTcO^4- 2-4 GBq eluate is added to the “CRS Isolink” kit for the preparation of tricarbonyl technetium [^99mTc(CO)₃(H₂O)₃]⁺ and incubated for 30 minutes at a temperature of 100°C, after incubation 400 mcl of tricarbonyl technetium is added to 3000 mcg of DARPinG3 and incubated at a temperature of 60°C for 60 minutes, then the resulting compound is purified from protein impurities and DARPinG3 molecules unbound to technetium using Sephadex G-25 Μ purification columns, radiochemical yield and purity are determined using thin-layer radiochromatography (TLRC), chromatogram analysis is carried out using a Hitachi Chromaster HPLC systems chromatograph with a radioactive detector. The drug obtained after purification is diluted in 10 ml of sterile 0.9% NaCl solution, taken through a sterilizing filter and slowly injected into the patient, 4 hours after administration, single-photon emission computed tomography of the thoracic organs and upper layer of the abdominal cavity organs is performed on a two-detector gamma camera. The study is performed before the start of treatment and then after the second course of systemic treatment, at each stage, the accumulation of the drug in the projection of mammary glands, regional lymph nodes and distant organs and tissues is evaluated, as well as tumor/background indicators in all existing tumor foci and in the absence of accumulation of the drug in the projection of mammary glands and regional lymph nodes positive therapy dynamics is determined.

EFFECT: use of the invention makes it possible to increase the accuracy, informativeness and accessibility of radionuclide diagnostics of breast cancer with HER2/neu overexpression.

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