The first Russian experience in the use of peptide-receptor radionuclide therapy 177Lu-DOTA-TATE in metastatic neuroendocrine tumors. Analysis of safety and preliminary treatment results

«Radiation and Risk», 2026, vol. 35, No. 1, pp.151-166

DOI: 10.21870/0131-3878-2026-35-1-151-166

Authors

Shurinov A.Yu. – Deputy Director of INM, C. Sc., Med. Contacts: 4 Korolev str., Obninsk, Kaluga region, Russia, 249035; e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it. .
Krylov V.V. – Director of INM, MD
Khvostunov I.К. – Chief Res., D. Sc., Biol.
Sigov M.A. – Head of Dер., Radiologist
Sidorenko E.А. – Radiologist
Borodavina E.V. – Sen. Res., C. Sc., Med.
Stepanenko V.F. – Head of Lab., D. Sc., Biol., Prof.
Petukhov A.D. – Sen. Res., C. Sc., Biol
Severskaya N.V. – Head of Dept., C. Sc. Med.
Tishchenko V.K. – Head of Lab., D. Sc., Biol.
Ivanov S.A. – Director, Corr. Member of RAS, MD, Prof. of RUDN University Dep. A. Tsyb MRRC
Kaprin A.D. – General Director, Director of P. Hertsen MORI, Head of RUDN University Dep., Academician of RAS, MD, Prof. NMRRC.
¹ A. Tsyb MRRC, Obninsk
² Peoples' Friendship University of Russia named after Patrice Lumumba, Moscow
³ NMRRC, Obninsk
⁴ P. Hertsen MORI, Moscow

Abstract

The peptide-receptor radionuclide therapy method ¹⁷⁷Lu-DOTA-TATE has been actively used in international practice since 2016 for the treatment of metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and is included in clinical guidelines of international specialized scientific and medical communities. On March 13, 2024, the A. Tsyb Medical Radiology Research Center used the radiopharmaceutical drug ¹⁷⁷Lu-DOTA-TATE, synthesized directly at the medical facility using domestically produced ¹⁷⁷Lu [¹⁷⁷LuCl3], for the first time in Russia as part of a single-center, open-label, non-randomized clinical trial. This clinical trial included patients with metastatic neuroendocrine tumors; the study was conducted within the framework of an internal clinical trial protocol. The scientific objectives were to evaluate the safety and clinical efficacy of the domestic radiopharmaceutical ¹⁷⁷Lu-DOTA-TATE and to analyze the radiation exposure of medical personnel involved in the radio-chemical synthesis and treatment procedures. All patients underwent the full range of laboratory and instrumental studies required for this type of radionuclide therapy, including dynamic nephroscintig-raphy, PET/CT with 68Ga-DOTA-TATE, or SPECT/CT with 99mTc-EDDA/HYNIC-TOC. The treatment course consisted of 3-6 administrations of ¹⁷⁷Lu-DOTA-TATE (from 3.7 to 7.4 GBq) using a nephro-protective protocol including intravenous coinfusion of an amino acid solution. During the treatment, no significant hematological or nephrotoxicity was observed, nor were patient absorbed doses exceeding 1.4 Gy. Improved quality of life due to pain relief was observed in 100% of cases. Radiation exposure to engineering and medical personnel did not exceed the maximum permissible limits. Preliminary results concluded that the use of domestically produced ¹⁷⁷Lu-DOTA-TATE in the treatment of metastatic GEP-NETs is a safe and effective treatment method.

Key words
nuclear medicine, radionuclide therapy, peptide-receptor radionuclide therapy, radio-pharmaceutical drug, ¹⁷⁷Lu-DOTA-TATE, neuroendocrine tumor, ¹⁷⁷Lu-DOTA-TATE safety, absorbed dose.

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