Abstract
The aim of this paper was to describe the optimized labeling protocol and quality control measures used in the production of [90Y]DOTATOC, starting from three different radioactivity levels to treat one, two, or three patients per therapeutic session. We investigated three different starting radioactivity levels. For the low radioactivity preparation we used 5138±280 MBq of [90Y] isotope, for the medium radioactivity preparation we used 8893±900 MBq, and for the high radioactivity preparation we used 11250±715 MBq. The radiochemical purity levels for the low radioactivity preparation, medium radioactivity preparation, and high radioactivity preparation were 99.95±0.09, 99.84±0.34, and 99.84±0.53%, respectively, and the radiochemical yields of the labeling procedures were 77.52±1.28, 75.53±3.72, and 78.00±3.20%, respectively. Media fill validation of the process was performed, and the parameters of pH, bacterial endotoxins, sterility, and osmolality were tested at process control. All radiopharmaceutical preparations satisfied the predetermined specifications fixed in our protocol regardless of the starting radioactivity level. The validation of the method guaranteed the safety and quality of the final products, contributing to providing the basis for constructing an informative and successful clinical trial.
| Original language | English |
|---|---|
| Pages (from-to) | 265-270 |
| Number of pages | 6 |
| Journal | Nuclear Medicine Communications |
| Volume | 34 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - Mar 2013 |
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Keywords
- [Y]DOTATOC
- Neuroendocrine tumors
- Quality controls
- Radiopharmaceutical
ASJC Scopus subject areas
- Radiology Nuclear Medicine and imaging
Cite this
Production and quality control of [90Y]DOTATOC for treatment of metastatic neuroendocrine tumors : Results of 85 syntheses. / Biasiotto, Giorgio; Bertagna, Francesco; Zanella, Isabella; Biasiotto, Ugo; Savelli, Giordano; Caimi, Luigi; Bettinsoli, Giovanni; Giubbini, Raffaele; Chinol, Marco.
In: Nuclear Medicine Communications, Vol. 34, No. 3, 03.2013, p. 265-270.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Production and quality control of [90Y]DOTATOC for treatment of metastatic neuroendocrine tumors
T2 - Results of 85 syntheses
AU - Biasiotto, Giorgio
AU - Bertagna, Francesco
AU - Zanella, Isabella
AU - Biasiotto, Ugo
AU - Savelli, Giordano
AU - Caimi, Luigi
AU - Bettinsoli, Giovanni
AU - Giubbini, Raffaele
AU - Chinol, Marco
PY - 2013/3
Y1 - 2013/3
N2 - The aim of this paper was to describe the optimized labeling protocol and quality control measures used in the production of [90Y]DOTATOC, starting from three different radioactivity levels to treat one, two, or three patients per therapeutic session. We investigated three different starting radioactivity levels. For the low radioactivity preparation we used 5138±280 MBq of [90Y] isotope, for the medium radioactivity preparation we used 8893±900 MBq, and for the high radioactivity preparation we used 11250±715 MBq. The radiochemical purity levels for the low radioactivity preparation, medium radioactivity preparation, and high radioactivity preparation were 99.95±0.09, 99.84±0.34, and 99.84±0.53%, respectively, and the radiochemical yields of the labeling procedures were 77.52±1.28, 75.53±3.72, and 78.00±3.20%, respectively. Media fill validation of the process was performed, and the parameters of pH, bacterial endotoxins, sterility, and osmolality were tested at process control. All radiopharmaceutical preparations satisfied the predetermined specifications fixed in our protocol regardless of the starting radioactivity level. The validation of the method guaranteed the safety and quality of the final products, contributing to providing the basis for constructing an informative and successful clinical trial.
AB - The aim of this paper was to describe the optimized labeling protocol and quality control measures used in the production of [90Y]DOTATOC, starting from three different radioactivity levels to treat one, two, or three patients per therapeutic session. We investigated three different starting radioactivity levels. For the low radioactivity preparation we used 5138±280 MBq of [90Y] isotope, for the medium radioactivity preparation we used 8893±900 MBq, and for the high radioactivity preparation we used 11250±715 MBq. The radiochemical purity levels for the low radioactivity preparation, medium radioactivity preparation, and high radioactivity preparation were 99.95±0.09, 99.84±0.34, and 99.84±0.53%, respectively, and the radiochemical yields of the labeling procedures were 77.52±1.28, 75.53±3.72, and 78.00±3.20%, respectively. Media fill validation of the process was performed, and the parameters of pH, bacterial endotoxins, sterility, and osmolality were tested at process control. All radiopharmaceutical preparations satisfied the predetermined specifications fixed in our protocol regardless of the starting radioactivity level. The validation of the method guaranteed the safety and quality of the final products, contributing to providing the basis for constructing an informative and successful clinical trial.
KW - [Y]DOTATOC
KW - Neuroendocrine tumors
KW - Quality controls
KW - Radiopharmaceutical
UR - http://www.scopus.com/inward/record.url?scp=84873410301&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84873410301&partnerID=8YFLogxK
U2 - 10.1097/MNM.0b013e32835ce596
DO - 10.1097/MNM.0b013e32835ce596
M3 - Article
VL - 34
SP - 265
EP - 270
JO - Nuclear Medicine Communications
JF - Nuclear Medicine Communications
SN - 0143-3636
IS - 3
ER -