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

FIELD: medicine, oncology.

SUBSTANCE: invention can be used for diagnosing distant metastases in breast cancer patients with HER2/neu overexpression. The method includes scintigraphic studies and intravenous administration of a radiopharmaceuticals. The patient is injected with a radiopharmaceutical based on technetium-99m labeled recombinant targeted molecules DARPinG3. The radiopharmaceutical medicinal product is prepared immediately before administration under aseptic conditions: 1,000 µl of ^99mTcO^4- eluate are added to the 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 µl of tricarbonyl technetium is added to 3,000 µg 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 (TLX), chromatograms are analyzed using a Hitachi Chromaster HPLC systems chromatograph with a radioactive detector. The medicinal product obtained after purification with a 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. 4 hours after administration, the patient is subjected to single-photon emission computed tomography of the chest organs and distant organs on a two-detector gamma camera, and if areas of medicinal product hyperfixation are detected, a tumor lesion of distant organs and tissues is diagnosed.

EFFECT: use of the invention makes it possible to increase the accuracy, informativeness and availability of diagnostics of tumor lesions of distant organs and tissues in patients with breast cancer with HER2/neu overexpression.

1 cl, 3 dwg, 1 ex