METHOD FOR EVALUATING NEOADJUVANT SYSTEMIC THERAPY OF BREAST CANCER WITH HER2/NEU OVEREXPRESSION Russian patent published in 2020 - IPC G01N33/48 

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to oncology, particularly to cradionuclide diagnostics, and can be used to evaluate the neoadjuvant systemic therapy in the patients with Her2/neu overexpression. Method involves radionuclide diagnostics with intravenous introduction of a radiopharmaceutical with subsequent single-photon emission computed tomography before neoadjuvant chemotherapy and after 2, 4 and 6 courses. Patients are administered a radiopharmaceutical preparation based on technetium-99m labeled recombinant address molecules DARPin9_29, which is prepared immediately before administration. In aseptic conditions, 1 ml of eluate 99mTcO4 – 7 GBq is added to a set for preparing tricarbonyl technetium using a syringe and incubated at temperature of 100 °C for 30 minutes, after incubation 1,000 mcl of technetium tricarbonyl are added to 334 mcl of DARPin9_29 at concentration of basic substance solution of 3.6 mg/l and incubated at temperature of 40 °C for 60 minutes, obtained compound is purified from protein impurities and not bound with technetium of DARPin9_29 molecules using purification columns. Preparation obtained after cleansing in dose of 500 MBq is diluted in 10 ml of physiologic saline and slowly introduced through a sterilizing filter to a patient, 4 hours after the administration of the preparation, the single-photon emission computed tomography is performed on a two-detector gamma camera and the primary tumor is evaluated, as well as tumor/background ratio, wherein sequential reduction of intensity of accumulation of drug in projection of tumor and reduced ratio of tumor/background ratio at diagnostic stages indicates a positive clinical course.

EFFECT: use of the invention provides higher accuracy, specificity, information value of diagnostics.

1 cl, 3 dwg, 1 ex