Journal of Radiation Safety and Measurement

Journal of Radiation Safety and Measurement

Production and Quality Control of Yttrium-90 Resin Microspheres for Radioembolization of Liver Cancer

Document Type : Original Article

Authors
Fariba Johari Deha 1
Samaneh Zolghadri 2
Arezou Karimian 2
Hassan Yousefnia 2
1 Radiation Applications Research School, Nuclear Science and Technology Research Institute (NSTRI), AEOI, Tehran, Iran
2 Radiation Application Research School, Nuclear Science and Technology Research Institute, Tehran, Iran.
10.22052/rsm.2025.256988.1131
Abstract
Hepatocellular carcinoma (HCC) is the most common primary liver malignancy and one of the leading causes of cancer-related mortality worldwide. Due to limitations associated with liver transplantation and surgical resection, radioembolization using yttrium-90 (Y-90) microspheres has gained attention as an effective locoregional treatment. In this study, Y-90 resin microspheres were prepared using Dowex 1×8 ion-exchange resin, and a comprehensive quality control assessment was performed. The final product demonstrated a high radiochemical purity exceeding 99%, a labeling efficiency over 92%, and excellent stability, with purity remaining above 98% after 48 hours. Moreover, sterility, endotoxin levels, and particle size distribution were all within the acceptable limits defined by international pharmacopeia standards. The use of Dowex resin, known for its affordability, availability, and favorable ion-exchange capacity, provided a simple and efficient platform for microsphere preparation. The results indicate that the formulated Y-90 microspheres meet clinical-grade criteria and hold significant potential for application in selective internal radiation therapy (SIRT) of liver cancers. This approach offers a cost-effective and scalable strategy for domestic production of therapeutic radiopharmaceuticals and represents a valuable step toward self-sufficiency in treating advanced liver tumors.
Keywords
Liver cancer
yttrium-90
microspheres
Ion exchange resin
  1. A. C. Gordon. Tuning your RADIOembolization: Imaging-guidance of Yttrium-90 Radioembolization. Thesis, Northwestern University, 2016.
  2. R. Salem, R. J. Lewandowski. Chemoembolization and radioembolization for hepatocellular carcinoma. Clin. Gastroenterol. Hepatol. 11 (6) (2013) 604-611.
  3. N. Fidelman, R. K. Kerlan Jr. Transarterial chemoembolization and 90Y radioembolization for hepatocellular carcinoma: review of current applications beyond intermediate-stage disease. Amer. J. Roentgenol. 205 (4) (2015) 742-752.
  4. S. D. Ryder. Guidelines for the diagnosis and treatment of hepatocellular carcinoma (HCC) in adults. Gut. 52 (suppl 3) (2003) iii1-8.
  5. B. Sangro, L. Carpanese, R. Cianni, R. Golfieri, D. Gasparini, S. Ezziddin, P. M Paprottka, F. Fiore, M. Van Buskirk, J. I. Bilbao, G. M. Ettorre, R. Salvatori, E. Giampalma, O. Geatti, K. Wilhelm, R. T. Hoffmann, F. Izzo, M. Iñarrairaegui, C. Ludovico Maini, C. Urigo, A. Cappelli, A. Vit, H. Ahmadzadehfar, T. F. Jakobs, S. Lastoria. Survival after yttrium-90 resin microsphere radioembolization of hepatocellular carcinoma across Barcelona clinic liver cancer stages: a European evaluation. Hepatol. 54 (3) (2011) 868-878.
  6. C. A. Arnold, M. K. Pezhouh, D. Lam-Himlin, M. E. Pittman, C. VandenBussche, L. Voltaggio. 90Y-TheraSpheres: the new look of Yttrium-90. The Amer. J. Surgical Pathol. 43 (5) (2019) 688-694.
  7. E. Garin, Y. Rolland, S. Laffont, J. Edeline. Clinical impact of 99m Tc-MAA SPECT/CT-based dosimetry in the radioembolization of liver malignancies with 90 Y-loaded microspheres. Eur. J. Nucl. Med. Mol. Imaging 43 (2016) 559-575.
  8. J. C. De La Vega, P. L. Esquinas, C. Rodríguez-Rodríguez, M. Bokharaei, I. Moskalev, D. Liu, K. Saatchi, U. O. Häfeli. Radioembolization of hepatocellular carcinoma with built-in dosimetry: first in vivo results with uniformly-sized, biodegradable microspheres labeled with 188Re. Theranostics 9 (3) (2019) 868.
  9. United States Pharmacopeia. USP <71> Sterility Tests. Available at: https://www.usp.org/harmonization-standards/pdg/general-methods/sterility-test.
  10. United States Pharmacopeia. USP <85> Bacterial Endotoxins Test. Available at: https://www.usp.org/harmonization-standards/pdg/general-methods/bacterial-endotoxins.
  11. A. Riaz, R. J. Lewandowski, L. Kulik, R. Salem. Yttrium-90 radioembolization using TheraSphere in the management of primary and secondary liver tumors. Q. J. Nucl. Med. Mol. Imaging 53 (3) (2009) 311-316.
  12. C. Van De Wiele, L. Defreyne, M. Peeters, B. Lambert. Yttrium-90 labelled resin microspheres for treatment of primary and secondary malignant liver tumors. Q. J. Nucl. Med. Mol. Imaging 53 (3) (2009) 317-324.
  13. M. S. Bhangoo, D. R. Karnani, P. N. Hein, H. Giap, H. Knowles, C. Issa, S. Steuterman, P. Pockros, C. Frenette. Radioembolization with Yttrium-90 microspheres for patients with unresectable hepatocellular carcinoma. J. Gastrointest Oncol. 6 (5) (2015) 469-478.
  14. M. T. Khoa, M. H. Bang, P. M. Thong, V. D. Luu, T. H. Binh, H. T. Chau, N. T. Thinh, T. D. Ky, P. V. Thai, N. D. Anh, P. C. Phuong. Safety and effectiveness of selective internal radiation therapy with SIR-Spheres Y-90 resin microspheres for treatment of hepatocellular carcinoma: A prospective observational study. Advances in Radiotherapy Nucl. Med. 1 (1) (2023) 0385.
  15. Y. Anbari, F. E.Veerman, G. Keane, A. J. A. T. Braat, M. L. J. Smits, R. C. G. Bruijnen, W. Tan, Y. Li, F. Duan, M. G. E. H.  Lam. Current status of yttrium-90 microspheres radioembolization in primary and metastatic liver cancer. J.  Intervent. Med. 6 (4) (2023) 153-159.
  16. L. Xiao, Y. Li, R. Geng, L. Chen, P. Yang, M. Li, X. Luo, Y. Yang, L. Li, H. Cai. Polymer composite microspheres loading 177Lu radionuclide for interventional radioembolization therapy and real-time SPECT imaging of hepatic cancer. Biomater Res. 27 (2023) 2518-2531.
  17. W. Łada, E. Iller, D. Wawszczak, M. Konior, T. Dziel. 90Y microspheres prepared by sol-gel method, promising medical material for radioembolization of liver malignancies. Mater. Sci. Eng. C. Mater. Biol. Appl. 67 (2016) 629-635.