METHOD OF BREAST CANCER DIAGNOSTICS WITH HER2/NEU HYPEREXPRESSION Russian patent published in 2023 - IPC A61B6/03 

FIELD: medicine, oncology.

SUBSTANCE: invention can be used for diagnosing breast cancer with HER2/neu overexpression. The method involves the administration of a radiopharmaceutical based on technetium-99m-labeled recombinant targeted DARPinG3 molecules, which is prepared immediately before administration, under aseptic conditions. 1,000 µl of ^99mTcO^4- eluate are added to the kit for preparation of [^99mTc(CO)3(H2O)3]⁺ tricarbonyl technetium and incubated for 30 minutes at 100°C. After incubation, 400 μl of tricarbonyl technetium is added to 3,000 μg of DARPinG3 and incubated at 60°C for 60 minutes. The resulting compound is purified from protein impurities and DARPinG3 molecules not bound to technetium using purification columns, radiochemical yield and purity are determined using thin-layer radiochromatography, chromatograms are analyzed using a Hitachi Chromaster HPLC systems chromatograph with a radioactive detector. The medicinal product obtained after purification with radioactivity of 200–500 MBC is diluted in 10 ml of a sterile 0.9% NaCl solution, taken through a sterilizing filter and slowly administered to the patient at a dose of 3,000 μg. Then, after 4 hours, single-photon emission tomography (SPECT) of the chest and upper floor of the abdominal organs is performed on a two-detector gamma camera and the accumulation of the medicinal product in the projection of the mammary glands, regional lymph nodes and distant organs and tissues is assessed, and a malignant tumor is diagnosed when visualizing areas of hyperfixation.

EFFECT: use of the invention makes it possible to accurately assess the prevalence of the tumor process in the projection of the mammary glands, regional lymph nodes, organs of the chest and liver at the metabolic level, and the degree of accumulation of the presented radiopharmaceutical in the tumor makes it possible to obtain scintigraphic images of proper quality in the diagnosis of breast cancer with overexpression of Her2/neu.

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