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Supply and clinical application of Actinium-225 and Bismuth-213.
Open accessAbstract
The recent development of 225Ac-PSMA617 for therapy of prostate cancer has strikingly demonstrated the clinical potential of targeted alpha therapy. Further promising applications of the alpha emitters 225Actinium and its daughter nuclide 213Bismuth include the therapy of brain tumors, bladder cancer, neuroendocrine tumors, and leukemia. This paper will provide a brief overview on the current status of the clinical development of compounds labelled with 225Ac or 213Bi and describe the various production routes that are in place or are under development to meet the increasing demand for these radionuclides.
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“Worldwide, only three sources of 229Th are available (81).”
From Alpha-peptide receptor radionuclide therapy using actinium-225 labeled somatostatin receptor agonists and antagonists (2022) · cites this paper as [81]
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“61 min), which also can be applied in TAT (19).”
BackgroundBismuth-213 for targeted radionuclide therapy: from atom to bedside.
Ahenkorah, S., Cassells, I., Deroose, C. M., Cardinaels, T., Burgoyne, A. R., Bormans, G., Ooms, M., & Cleeren, F. (2021) · Pharmaceutics · doi:10.3390/pharmaceutics13050599 · Cited by 120
“Also, the transient equilibrium of the 225Ac-213Bi permits elution at approximately every 3 h [40].”
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Actinium-225 targeted alpha particle therapy for prostate cancer
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“Another approach to produce the 225 Ac is via photonuclear 226 Ra( ɣ ,n) 225 Ra reaction, where generated 225 Ra decays to 225 Ac [87].”
Background212Pb: Production Approaches and Targeted Therapy Applications
Коков, К. В., Egorova, B. V., German, M. N., Klabukov, I., Крашенинников, М. Е., Ларкин, А. А., Makoveeva, K. A., Ovchinnikov, M. V., Sidorova, M. V., & Chuvilin, D. (2022) · Pharmaceutics · doi:10.3390/pharmaceutics14010189 · Cited by 90
Harnessing α -Emitting Radionuclides for Therapy: Radiolabeling Method Review
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“The reader is directed toward another recent review for additional information on 213 Bi radiopharmaceuticals ( 8 ). a -”
BackgroundHooijman, E. L., Radchenko, V., Ling, S. W., Konijnenberg, M., Brabander, T., Koolen, S. L. W., & de Blois, E. (2024) · EJNMMI Radiopharmacy and Chemistry · doi:10.1186/s41181-024-00239-1 · Cited by 91
Shi, M., Jakobsson, V., Greifenstein, L., Khong, P.-L., Chen, X., Baum, R. P., & Zhang, J. (2022) · Frontiers in Medicine · doi:10.3389/fmed.2022.1034315 · Cited by 68
“In addition, issues with licensing and clinical safe handling need to be resolved (81).”
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“One of the reasons is the limited production capacity of Ac-225 for therapeutic use [64], and there is also a lack of standardized techniques for the good manufacturing practice (GMP) production of [225Ac]Ac-PSMA.”
Global experience with PSMA-based alpha therapy in prostate cancer
Sathekge, M. M., Bruchertseifer, F., Vorster, M., Morgenstern, A., & Lawal, I. O. (2021) · European Journal of Nuclear Medicine and Molecular Imaging · doi:10.1007/s00259-021-05434-9 · Cited by 58
Fiszbein, D. J., Brown, V., Thiele, N. A., Woods, J. J., Wharton, L., MacMillan, S. N., Radchenko, V., Ramogida, C. F., & Wilson, J. J. (2021) · Inorganic Chemistry · doi:10.1021/acs.inorgchem.1c01269 · Cited by 54
Peptide Receptor Radionuclide Therapy
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Zimmermann, R. (2023) · Journal of Nuclear Medicine · doi:10.2967/jnumed.123.265907 · Cited by 48
“The different routes have been described in the literature (3,4).”
BackgroundTheoretical Study of Actinide Complexes with Macropa
Kovács, A. (2020) · ACS Omega · doi:10.1021/acsomega.0c02873 · Cited by 43
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Jalloul, W., Ghizdovăţ, V., Stolniceanu, C. R., Ionescu, T. M., Grierosu, I. C., Păvăleanu, I., Moscalu, M., & Ştefănescu, C. (2023) · Pharmaceuticals · doi:10.3390/ph16121679 · Cited by 40
“According to preliminary research, the 227 Ac impurity will not significantly affect patient dosimetry [78].”
BackgroundMethodInfluentialCommercial and business aspects of alpha radioligand therapeutics
Ostuni, E., & Taylor, M. R. G. (2023) · Frontiers in Medicine · doi:10.3389/fmed.2022.1070497 · Cited by 35
“While the clinical application of 225Ac-PSMA-617 was further developed with the collaboration of JRC and hospitals in Heidelberg, Pretoria and Munich, the remarkable potential of 225Ac also gained worldwide interest due to its use in a growing number of studies for patients with late mCRPC (86, 87).”
BackgroundHassan, M., Bokhari, T. H., Lodhi, N. A., Khosa, M. K., & Usman, M. (2023) · Chemical Biology & Drug Design · doi:10.1111/cbdd.14311 · Cited by 33
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Malo, M. E., Allen, K. J. H., Jiao, R., Frank, C., Rickles, D. J., & Dadachova, E. (2020) · International Journal of Molecular Sciences · doi:10.3390/ijms21228721 · Cited by 29
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“It was created by adding the latest data [26–28] to the 2018 document [25].”
MethodOptimizing the Safety and Efficacy of Bio-Radiopharmaceuticals for Cancer Therapy
Funeh, C. N., Bridoux, J., Ertveldt, T., Groof, T. W. M. D., Chigoho, D. M., Asiabi, P., Covens, P., D’Huyvetter, M., & Devoogdt, N. (2023) · Pharmaceutics · doi:10.3390/pharmaceutics15051378 · Cited by 28
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BackgroundLiu, Y., Tang, H., Song, T., Xu, M., Chen, J., Cui, X.-Y., Han, Y., Li, Z., & Liu, Z. (2023) · European Journal of Nuclear Medicine and Molecular Imaging · doi:10.1007/s00259-023-06230-3 · Cited by 27
“213Bi was eluted from an 225Ac/213Bi generator according to a previously-reported protocol [19].”
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Photonuclear production of medical radiometals: a review of experimental studies
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“225Ac (T1/2 = 10 d) is an α-emitter which usefulness in nuclear medicine in was proved in many studies [48].”
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Kovács, A. (2021) · ACS Omega · doi:10.1021/acsomega.1c01292 · Cited by 26
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Rahman, A. K. M. R., Babu, M. H., Ovi, M. K., Zilani, M. M., Eithu, I. S., & Chakraborty, A. (2024) · Journal of Medical Physics · doi:10.4103/jmp.jmp_22_24 · Cited by 25
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“Bismuth-213 (T 1/2 = 45.6 min, β − = 97.8%, < E β> = 436 keV, α cumulative = 100%, < E α cumulative > = 8.32 MeV) has been used preclinically and clinically with antibodies and peptides (Morgenstern et al. 2020).”
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“In the recent overview, Morgenstern et al.[2] have highlighted a shortage of high-activity generators required for the preparation of multi-GBq patient doses of 213Bi.”
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Ermolaev, S. V., Skasyrskaya, A. K., & Vasiliev, A. N. (2021) · Pharmaceutics · doi:10.3390/pharmaceutics13060914 · Cited by 18
“Introduction The radionuclide, 213Bi, is considered as one of the promising radionuclides for targeted therapy of cancer [1,2].”
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“Recent reports have often suggested that radiolabeled compounds containing α-ray emitting radionuclides showed better therapeutic effects than those using β − -emitting radionuclides (McDevitt et al. 2018; Morgenstern et al. 2020; Sgouros et al. 2020).”
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“Although high-activity 225 Ac/ 213 Bi generator systems have been developed [58,59], the primary bottleneck remains the limited global availability of the parent isotope actinium-225.”
Radiopharmaceutical Quality Control Considerations for Accelerator-Produced Actinium Therapies
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“, elution of a thorium-229 ((229)Th) generator–produces several times less than the estimated need for routine clinical practice.(12,13) Demand for the isotope has spurred several developmental efforts, including cyclotron, electron, or photon irradiation of radium-226,(14,15) and spallation of thorium targets by high…”
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Mdanda, S., Ngema, L. M., Mdlophane, A. H., Sathekge, M. M., & Zeevaart, J. R. (2023) · Pharmaceutics · doi:10.3390/pharmaceutics15061719 · Cited by 14
“Additional approaches for large-scale production of 225Ac have been devised to meet the global demand, and these include the spallation of highly energetic protons onto 232Th or U targets, as well as the irradiation of 226Ra targets with protons, deuterons, or gamma rays [4].”
BackgroundMethodYang, H., Zhang, Y., Li, H., Feng, Y., Yang, X.-Q., & Chen, Y. (2024) · Clinical Nuclear Medicine · doi:10.1097/rlu.0000000000005149 · Cited by 15
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“…to the generated x-ray beams to produce [ 225 Ra]Ra (t 1/2 = 14.9 d), which decays to give [ 225 Ac]Ac according to the following designed and experimentally tested photonuclear reaction [29,37,43]: Hence, 20 mg of [ 226 Ra]Ra is placed at a distance of 12.5 cm from the bremsstrahlung target.”
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“4 – 8, Supplementary Table 1).”
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“However, issues in the production, supply and dosimetry of alpha-emitting radiopharmaceuticals are still limiting their widespread employment [40, 47]; innovative approaches are needed to overcome these hurdles [14, 22, 45].”
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Bergeron, D. E., Kossert, K., Collins, S. M., & Fenwick, A. (2022) · Applied Radiation and Isotopes · doi:10.1016/j.apradiso.2022.110161 · Cited by 11
Ab initiostudy of electronic states and radiative properties of the AcF molecule
Skripnikov, L. V., Oleynichenko, A. V., Zaitsevskii, A. V., Mosyagin, N. S., Athanasakis-Kaklamanakis, M., Au, M., & Neyens, G. (2023) · The Journal of Chemical Physics · doi:10.1063/5.0159888 · Cited by 11
Emerging Therapeutic Radiopharmaceuticals and Their Theranostic Pairs
Carbo‐Bague, I., & Ramogida, C. F. (2021) · Wiley eBooks · doi:10.1002/9781119951438.eibc2763 · Cited by 12
Jalilian, A. R., Kleynhans, J., Bouziotis, P., Bruchertseifer, F., Chakraborty, S., de Blois, E., Denecke, M. A., Elboğa, U., Gizawy, M. A., Horak, C. I., et al. (2025) · Nuclear Medicine and Biology · doi:10.1016/j.nucmedbio.2025.109008 · Cited by 10
Feasibility of a novel photoproduction of 225Ac and 227Th with natural thorium target
Ju, K., & Kim, Y. (2022) · Scientific Reports · doi:10.1038/s41598-021-04339-9 · Cited by 10
Ermolaev, S. V., Vasiliev, A. N., Lapshina, E. V., Kobtsev, A. A., & Zhuikov, B. L. (2024) · New Journal of Chemistry · doi:10.1039/d3nj05778j · Cited by 10
Zhuikov, B. L., & Ermolaev, S. V. (2021) · Physics-Uspekhi · doi:10.3367/ufne.2021.07.039010 · Cited by 10
Theragnostic radionuclides: a clinical perspective
KOZIOROWSKI, J., & Ballinger, J. R. (2021) · The Quarterly Journal of Nuclear Medicine and Molecular Imaging · doi:10.23736/s1824-4785.21.03424-5 · Cited by 10
Iorio, V. D., Sarnelli, A., Boschi, S., Sansovini, M., Genovese, R. M., Ştefănescu, C., Ghizdovăţ, V., Jalloul, W., Young, J. D., Sosabowski, J. K., et al. (2025) · Pharmaceuticals · doi:10.3390/ph18101578 · Cited by 10
“Since deuteron irradiation might result in an increased co-production of actinium-226 (T1/2 = 29 h), a prolonged cooling time should be considered to allow the actinium-226 decay [25].”
InfluentialDetection of the Lowest-Lying Odd-Parity Atomic Levels in Actinium
Zhang, K., Studer, D., Weber, F., Gadelshin, V. M., Kneip, N., Raeder, S., Budker, D., Wendt, K., Kieck, T., Porsev, S. G., et al. (2020) · Physical Review Letters · doi:10.1103/physrevlett.125.073001 · Cited by 9
225 Ac/ 213 Bi radionuclide generators for the separation of 213 Bi towards clinical demands
Zhu, H., Heinitz, S., Binnemans, K., Mullens, S., & Cardinaels, T. (2024) · Inorganic Chemistry Frontiers · doi:10.1039/d4qi00326h · Cited by 9
Chen, Q., Li, Z., Yu, J., Xie, Q., Lu, H., Deng, Y., Chen, J., Zhu, W., Huo, L., Zhang, Y., et al. (2022) · Nano Research · doi:10.1007/s12274-022-4555-4 · Cited by 8
“Importantly, this approach can distinguish patients who may benefit from peptide receptor radionuclide therapy with analogues labelled with β−-emitters or, more recently, α-emitters [23, 24].”
BackgroundInvestigating the Bismuth Complexes with Benzoazacrown Tri‐ and Tetra‐Acetates
Egorova, B. V., Matazova, E. V., Aleshin, G. Y., Zubenko, A. D., Вячеславовна, П. А., Konopkina, E. A., Mitrofanov, A. A., Smirnova, A. A., Trigub, A. L., Карноухова, В. А., et al. (2021) · European Journal of Inorganic Chemistry · doi:10.1002/ejic.202100256 · Cited by 8
Severin, A. V., Vasiliev, A. N., Gopin, A. V., & Enikeev, �. K. (2020) · Russian Chemical Bulletin · doi:10.1007/s11172-020-3041-y · Cited by 8
Li, C., Zhang, Y., Wei, Z., Sun, Y., Yang, L., Gao, Y., Wang, W., & Zhang, Y. (2025) · Applied Radiation and Isotopes · doi:10.1016/j.apradiso.2025.111981 · Cited by 7
Clinical Image-Based Dosimetry of Actinium-225 in Targeted Alpha Therapy
Ramonaheng, K., Banda, K., Qebetu, M., Goorhoo, P., Legodi, K., Masogo, T., Seebarruth, Y., Mdanda, S., Sibiya, S. M., Mzizi, Y. V., et al. (2026) · Cancers · doi:10.3390/cancers18020321 · Cited by 8
“A 24 h irradiation of ~50 mg of 226 Ra at 100 µ A typically yields around 5 GBq of 225 Ac, sufficient for several hundred clinical doses, demonstrating both efficiency and scalability [28,53].”
McDonagh, A. W., McNeil, B. L., Rousseau, J., Roberts, R., Merkens, H., Yang, H., Bénard, F., & Ramogida, C. F. (2022) · EJNMMI Radiopharmacy and Chemistry · doi:10.1186/s41181-022-00164-1 · Cited by 7
Production and Quality Control of Actinium-225 Radiopharmaceuticals
INTERNATIONAL ATOMIC ENERGY AGENCY (2024) · International Atomic Energy Agency eBooks · doi:10.61092/iaea.95h3-2ji2 · Cited by 7
Dual-targeted alpha therapy mitigates prostate cancer and boosts immune checkpoint blockade therapy
Sun, J., Yang, J., Guo, J., Tao, L., Xu, B., Wang, G., Meng, F., & Zhong, Z. (2025) · Journal of Controlled Release · doi:10.1016/j.jconrel.2025.113686 · Cited by 7
Production and purification of molecular 225Ac at CERN-ISOLDE
Au, M., Nies, L., Stegemann, S., Athanasakis-Kaklamanakis, M., Cocolios, T. E., Fischer, P., Giesel, P. F., Johnson, J. D., Köster, U., Lange, D., et al. (2024) · Journal of Radioanalytical and Nuclear Chemistry · doi:10.1007/s10967-024-09811-0 · Cited by 8
Kovács, A., & Varga, Z. (2021) · Structural Chemistry · doi:10.1007/s11224-020-01717-3 · Cited by 6
Bravo, M. G., Egorova, B. V., Vasiliev, A. N., Lapshina, E. V., Ermolaev, S. V., & Durymanov, M. O. (2023) · Current Radiopharmaceuticals · doi:10.2174/1874471016666230221102518 · Cited by 6
Johnson, J. D., Bernerd, C., Bruchertseifer, F., Cocolios, T. E., Deseyn, M., Duchemin, C., Heines, M., Keppens, M., Lambert, L., Meurrens, N., et al. (2025) · Scientific Reports · doi:10.1038/s41598-025-02277-4 · Cited by 5
Ghaseminejad, S., Sarno, D. D., Bauman, G. S., & Lee, T. (2025) · Medical Physics · doi:10.1002/mp.18035 · Cited by 8
“33,37,52 Besides RBE, a further evaluation of these radionuclides is to compare self-irradiation and crossfire contributions.”
Aktuelle radiopharmazeutische Entwicklungen für die theranostische Anwendung
Neels, O. C., Kratochwil, C., & Patt, M. (2021) · Der Nuklearmediziner · doi:10.1055/a-1474-8976 · Cited by 5
“Die Verfügbarkeit von Actinium-225 ist derzeit mangels Zulassung noch deutlich eingeschränkt [33, 34] und die Anwendung daher nur in Ausnahmefällen möglich.”
BackgroundProduction of radionuclides: Cyclotrons and reactors
Benešová, M., & Reischl, G. (2021) · Elsevier eBooks · doi:10.1016/b978-0-12-822960-6.00003-x · Cited by 5
Zhu, H., Heinitz, S., Eyley, S., Thielemans, W., Derveaux, E., Adriaensens, P., Binnemans, K., Mullens, S., & Cardinaels, T. (2023) · RSC Advances · doi:10.1039/d3ra06130b · Cited by 5
Medicine: Radionuclides Used in Nuclear Medicine
Venkatesh, M., & Kang, K. W. (2021) · Elsevier eBooks · doi:10.1016/b978-0-12-819725-7.00177-x · Cited by 5
225Aс/213Bi generator for direct synthesis of 213Bi-labeled bioconjugates
Ermolaev, S. V., Vasiliev, A. N., Skasyrskaya, A. K., Lapshina, E. V., Khaliullina, D. R., & Libanova, O. N. (2024) · Nuclear Medicine and Biology · doi:10.1016/j.nucmedbio.2024.108975 · Cited by 4
Yamamichi, G., Kato, T., Watabe, T., Hatano, K., Uemura, M., & Nonomura, N. (2024) · Anticancer Research · doi:10.21873/anticanres.16881 · Cited by 5
Development of 225Ac/213Bi generator based on α-ZrP-PAN composite for targeted alpha therapy
Ondrák, L., Fialová, K. O., Sakmár, M., Vlk, M., Bruchertseifer, F., Morgenstern, A., & Kozempel, J. (2024) · Nuclear Medicine and Biology · doi:10.1016/j.nucmedbio.2024.108909 · Cited by 4
Peptides as Vectors for Radiopharmaceutical Therapy
Davis, R. A., Ganguly, T., Hausner, S. H., & Sutcliffe-Goulden, J. (2023) · Springer eBooks · doi:10.1007/978-3-031-39005-0_13 · Cited by 4
Vasiliev, A. N., Ermolaev, S. V., Lapshina, E. V., Bravo, M. G., & Skasyrskaya, A. K. (2022) · Solvent Extraction and Ion Exchange · doi:10.1080/07366299.2022.2088059 · Cited by 4
“Radiopharmaceuticals containing (225)Ac and its daughter (213)Bi are successfully passing clinical trials for the treatment of leukemia, NHL, carcinoma, neuroendocrine tumor, glioma melanoma, and other malignant diseases.([14,15]) Radiopharmaceutical Xofigo on the base of (223)Ra is already approved for a common appli…”
BackgroundMeasurement of 227 Ac by Isotopic Ratio with 225 Ac Using ICP-MS
Baumeister, J. E., Puffer, B. W., Hawkins, C. A., McCormick, J. B., Toro-González, M., Brown, J. W. N., & de Vries, D. J. (2025) · ACS Omega · doi:10.1021/acsomega.5c09343 · Cited by 3
Kuhlmann, A.-S., Hamlin, D. K., Li, Y., Wang, X., Li, L., Orvig, C., Kiem, H., Sandmaier, B. M., Wilbur, D. S., Pincus, S. H., et al. (2026) · Nuclear Medicine and Biology · doi:10.1016/j.nucmedbio.2026.109602 · Cited by 3
Kuhlmann, A.-S., Peters, T. R., Hamlin, D. K., Li, Y., Wang, X., Stackhouse, M., Cole, F. M., Martinez-Reyes, J., Sandmaier, B. M., Kiem, H., et al. (2026) · Antibodies · doi:10.3390/antib15010012 · Cited by 3
“RICs, including those incorporating 225 Ac [66,67], have been investigated in clinical settings for cancer therapy and conditioning prior to stem cell transplantation, demonstrating encouraging results that highlight the potential of this radionuclide for clinical applications.”
Gas-chemical approach to 225Ac/213Bi radionuclide generator for medical application
Zobnin, V., Zhuikov, B. L., Vasiliev, A. N., & Polnyakov, G. A. (2024) · Applied Radiation and Isotopes · doi:10.1016/j.apradiso.2024.111581 · Cited by 3
Metadata
- Authors
- Morgenstern, A., Apostolidis, C., & Bruchertseifer, F.
- Affiliations
- European Commission (BE)
- Corresponding author
- Morgenstern, Alfred
- Venue
- Seminars in Nuclear Medicine
- Publisher
- Elsevier BV
- Published
- 2020-03
- Volume
- 50
- Issue
- 2
- Pages
- 119-123
- ISSN
- 0001-2998 (ISSN-L)
- PMC
- PMC7082773
- OpenAlex
- W3007334567
- Cited by
- 141
- References
- 45
- Citations by year
- 2026: 16 · 2025: 31 · 2024: 23 · 2023: 19 · 2022: 15 · 2021: 29 · 2020: 8
- FWCI
- 2.62
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Seminars in Nuclear Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Joint Research Centre (European Commission) (submittedVersion)
- Funders
- Joint Research Centre
- Topics
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Radiopharmaceutical Chemistry and Applications
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Chemical Reactions and Isotopes
- Physical Sciences › Physics and Astronomy › Radiation › Radioactive Decay and Measurement Techniques
- Keywords
- actinium-225, bismuth-213, targeted alpha therapy, prostate cancer, radioisotope production, radionuclide supply, alpha-emitting radionuclides, neuroendocrine tumors, brain tumors, leukemia, bladder cancer
- MeSH terms
- Actinium, Bismuth, Humans, Isotope Labeling, Male, Prostatic Neoplasms, Radioisotopes
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