Nuclear Data Sheets for A=160

Nica, N.

doi:10.1016/j.nds.2021.08.001

Cited by 10 publications

(2 citation statements)

References 329 publications

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“…Radionuclidic Purity. The content of the long-lived impurity 160 Tb (half-life, 72.3 d) (30) was less than 0.005% of the total 161 Tb activity at end of bombardment (EOB), as reported previously by our group (20). Three weeks after EOB, the level of 160 Tb was still no more than 0.03% (Supplemental Fig.…”

Section: Resultssupporting

confidence: 75%

“…monograph for 177 Lu ( 24 ). With regard to radionuclidic purity, long-lived 160 Tb (half-life, 72.3 d) ( 30 ) was found as an impurity; it is coproduced by the 159 Tb(n,γ) 160 Tb nuclear reaction, and the multistep reactions on the residual 159 Tb, 158 Gd, and 157 Gd present as impurities in the target material. However, the content did not exceed 0.005% of the total 161 Tb activity at EOB.…”

Section: Discussionmentioning

confidence: 99%

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¹⁶¹Tb-DOTATOC Production Using a Fully Automated Disposable Cassette System: A First Step Toward the Introduction of¹⁶¹Tb into the Clinic

et al. 2023

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Tb is an interesting radionuclide for application in the treatment of neuroendocrine neoplasms' small metastases and single cancer cells because of its conversion and Auger-electron emission. Tb has coordination chemistry similar to that of Lu; therefore, like 177 Lu, it can stably radiolabel DOTATOC, one of the leading peptides used for the treatment of neuroendocrine neoplasms. However, 161 Tb is a recently developed radionuclide that has not yet been specified for clinical use. Therefore, the aim of the current work was to characterize and specify 161 Tb and to develop a protocol for the synthesis and quality control of 161 Tb-DOTATOC with a fully automated process conforming to goodmanufacturing-practice guidelines, in view of its clinical use. Methods: 161 Tb, produced by neutron irradiation of 160 Gd in high-flux reactors followed by radiochemical separation from its target material, was characterized regarding its radionuclidic purity, chemical purity, endotoxin level, and radiochemical purity (RCP) in analogy to what is described in the European Pharmacopoeia for no-carrier-added 177 Lu. In addition, 161 Tb was introduced into a fully automated cassette-module synthesis to produce 161 Tb-DOTATOC, as used for 177 Lu-DOTATOC. The quality and stability of the produced radiopharmaceutical in terms of identity, RCP, and ethanol and endotoxin content were assessed by means of high-performance liquid chromatography, gas chromatography, and an endotoxin test, respectively. Results: 161 Tb produced under the described conditions showed, as the no-carrier-added 177 Lu, a pH of 1-2, radionuclidic purity and RCP of more than 99.9%, and an endotoxin level below the permitted range (175 IU/mL), indicating its appropriate quality for clinical use. In addition, an efficient and robust procedure for the automated production and quality control of 161 Tb-DOTATOC with clinically applicable specifications and activity levels, that is, 1.0-7.4 GBq in 20 mL, was developed. The radiopharmaceutical's quality control was also developed using chromatographic methods, which confirmed the product's stability (RCP $ 95%) over 24 h. Conclusion: The current study demonstrated that 161 Tb has appropriate features for clinical use. The developed synthesis protocol guarantees high yields and safe preparation of injectable 161 Tb-DOTATOC. The investigated approach could be translated to other DOTA-derivatized peptides; thus, 161 Tb could be successfully applied in clinical practice for radionuclide therapy.

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Section: Resultssupporting

confidence: 75%

Section: Discussionmentioning

confidence: 99%

¹⁶¹Tb-DOTATOC Production Using a Fully Automated Disposable Cassette System: A First Step Toward the Introduction of¹⁶¹Tb into the Clinic

et al. 2023

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Determination of the half-life of 161Tb

Dong

Bai

et al. 2023

Applied Radiation and Isotopes

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New experimental data on natDy(a,x) reactions: Details on the production of the medically relevant 161Er, 160Er, and 161Ho Auger emitters

Кормазева

Khomenko

Унежев

et al. 2022

Nuclear Instruments and Methods in Physics Research Section B:

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Nuclear Data Sheets for A=160

Cited by 10 publications

References 329 publications

¹⁶¹Tb-DOTATOC Production Using a Fully Automated Disposable Cassette System: A First Step Toward the Introduction of¹⁶¹Tb into the Clinic

¹⁶¹Tb-DOTATOC Production Using a Fully Automated Disposable Cassette System: A First Step Toward the Introduction of¹⁶¹Tb into the Clinic

Determination of the half-life of 161Tb

New experimental data on natDy(a,x) reactions: Details on the production of the medically relevant 161Er, 160Er, and 161Ho Auger emitters

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Nuclear Data Sheets for A=160

Cited by 10 publications

References 329 publications

161Tb-DOTATOC Production Using a Fully Automated Disposable Cassette System: A First Step Toward the Introduction of161Tb into the Clinic

161Tb-DOTATOC Production Using a Fully Automated Disposable Cassette System: A First Step Toward the Introduction of161Tb into the Clinic

Determination of the half-life of 161Tb

New experimental data on natDy(a,x) reactions: Details on the production of the medically relevant 161Er, 160Er, and 161Ho Auger emitters

Contact Info

Product

Resources

About

¹⁶¹Tb-DOTATOC Production Using a Fully Automated Disposable Cassette System: A First Step Toward the Introduction of¹⁶¹Tb into the Clinic

¹⁶¹Tb-DOTATOC Production Using a Fully Automated Disposable Cassette System: A First Step Toward the Introduction of¹⁶¹Tb into the Clinic