ES2562656T3 - Sistemas de calibración y normalización y métodos para sintetizadores radiofarmacéuticos - Google Patents
Sistemas de calibración y normalización y métodos para sintetizadores radiofarmacéuticos Download PDFInfo
- Publication number
- ES2562656T3 ES2562656T3 ES12787173.9T ES12787173T ES2562656T3 ES 2562656 T3 ES2562656 T3 ES 2562656T3 ES 12787173 T ES12787173 T ES 12787173T ES 2562656 T3 ES2562656 T3 ES 2562656T3
- Authority
- ES
- Spain
- Prior art keywords
- activity
- activity detector
- data
- calibration pattern
- radiosynthesizer
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- 238000000034 method Methods 0.000 title claims abstract description 113
- 239000012217 radiopharmaceutical Substances 0.000 title claims description 65
- 229940121896 radiopharmaceutical Drugs 0.000 title description 20
- 230000002799 radiopharmaceutical effect Effects 0.000 title description 20
- 230000000694 effects Effects 0.000 claims abstract description 212
- 238000003786 synthesis reaction Methods 0.000 claims abstract description 88
- 230000015572 biosynthetic process Effects 0.000 claims abstract description 86
- 230000005855 radiation Effects 0.000 claims abstract description 8
- 230000002194 synthesizing effect Effects 0.000 claims abstract description 3
- 238000013480 data collection Methods 0.000 claims description 73
- 239000000700 radioactive tracer Substances 0.000 claims description 8
- 238000003860 storage Methods 0.000 claims description 8
- 238000004364 calculation method Methods 0.000 claims description 7
- 230000001052 transient effect Effects 0.000 claims description 4
- 230000008569 process Effects 0.000 description 62
- 238000004519 manufacturing process Methods 0.000 description 28
- 238000002414 normal-phase solid-phase extraction Methods 0.000 description 19
- 238000002600 positron emission tomography Methods 0.000 description 18
- 238000000746 purification Methods 0.000 description 14
- 238000002603 single-photon emission computed tomography Methods 0.000 description 14
- 238000004458 analytical method Methods 0.000 description 13
- 238000006243 chemical reaction Methods 0.000 description 10
- 238000012986 modification Methods 0.000 description 9
- 230000004048 modification Effects 0.000 description 9
- 238000003908 quality control method Methods 0.000 description 9
- 239000000523 sample Substances 0.000 description 9
- 230000000875 corresponding effect Effects 0.000 description 8
- 239000012535 impurity Substances 0.000 description 8
- 238000005259 measurement Methods 0.000 description 8
- VXFFXZSNVKXXIB-SCSBXPEDSA-N 2-[(1r,4s,10r,13s,16r,19s,25s)-10-[2-[2-[2-[2-[[2-(2-amino-2-oxoethoxy)acetyl]amino]ethoxy]ethoxy]ethoxy]ethylcarbamoyl]-13-benzyl-25-[3-(diaminomethylideneamino)propyl]-4-[4-[[2-[2-[2-[2-[2-[2-[2-[2-[[2-[(e)-(4-fluorophenyl)methylideneamino]oxyacetyl]ami Chemical compound C([C@@H]1NC(=O)CSC[C@H](NC(=O)[C@H](CC=2C=CC=CC=2)NC(=O)[C@@H]2CSSC[C@@H](C(N[C@@H](CCCN=C(N)N)C(=O)NCC(=O)N[C@@H](CC(O)=O)C(=O)N2)=O)NC1=O)C(=O)NCCOCCOCCOCCNC(=O)COCC(=O)N)CCCNC(=O)COCC(=O)NCCOCCOCCOCCOCCOCCNC(=O)CO\N=C\C1=CC=C(F)C=C1 VXFFXZSNVKXXIB-SCSBXPEDSA-N 0.000 description 7
- 108010092045 AH 111585 Proteins 0.000 description 7
- 230000009471 action Effects 0.000 description 7
- 238000012360 testing method Methods 0.000 description 7
- 238000001514 detection method Methods 0.000 description 6
- 238000012937 correction Methods 0.000 description 5
- 230000006870 function Effects 0.000 description 4
- 238000011084 recovery Methods 0.000 description 4
- 238000007405 data analysis Methods 0.000 description 3
- 230000007812 deficiency Effects 0.000 description 3
- 201000010099 disease Diseases 0.000 description 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 3
- 238000010828 elution Methods 0.000 description 3
- 238000011156 evaluation Methods 0.000 description 3
- 238000010606 normalization Methods 0.000 description 3
- 239000002243 precursor Substances 0.000 description 3
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- KRHYYFGTRYWZRS-UHFFFAOYSA-M Fluoride anion Chemical compound [F-] KRHYYFGTRYWZRS-UHFFFAOYSA-M 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- NTEDWGYJNHZKQW-DGMDOPGDSA-N fluciclovine ((18)F) Chemical compound OC(=O)[C@]1(N)C[C@H]([18F])C1 NTEDWGYJNHZKQW-DGMDOPGDSA-N 0.000 description 2
- 229940027541 fluciclovine f-18 Drugs 0.000 description 2
- 239000012530 fluid Substances 0.000 description 2
- 230000014509 gene expression Effects 0.000 description 2
- UYTPUPDQBNUYGX-UHFFFAOYSA-N guanine Chemical compound O=C1NC(N)=NC2=C1N=CN2 UYTPUPDQBNUYGX-UHFFFAOYSA-N 0.000 description 2
- 239000012216 imaging agent Substances 0.000 description 2
- 238000003384 imaging method Methods 0.000 description 2
- 229910052757 nitrogen Inorganic materials 0.000 description 2
- 230000005258 radioactive decay Effects 0.000 description 2
- 230000002285 radioactive effect Effects 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 238000012546 transfer Methods 0.000 description 2
- 238000013024 troubleshooting Methods 0.000 description 2
- MKXBOPXRKXGSTI-PJKMHFRUSA-N 1-[(2s,4s,5r)-2-fluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]-5-methylpyrimidine-2,4-dione Chemical compound O=C1NC(=O)C(C)=CN1[C@]1(F)O[C@H](CO)[C@@H](O)C1 MKXBOPXRKXGSTI-PJKMHFRUSA-N 0.000 description 1
- WGCYRFWNGRMRJA-UHFFFAOYSA-N 1-ethylpiperazine Chemical compound CCN1CCNCC1 WGCYRFWNGRMRJA-UHFFFAOYSA-N 0.000 description 1
- 125000004204 2-methoxyphenyl group Chemical group [H]C1=C([H])C(*)=C(OC([H])([H])[H])C([H])=C1[H] 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- QJGQUHMNIGDVPM-BJUDXGSMSA-N Nitrogen-13 Chemical compound [13N] QJGQUHMNIGDVPM-BJUDXGSMSA-N 0.000 description 1
- GKLVYJBZJHMRIY-OUBTZVSYSA-N Technetium-99 Chemical compound [99Tc] GKLVYJBZJHMRIY-OUBTZVSYSA-N 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 230000006978 adaptation Effects 0.000 description 1
- 125000000484 butyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- 201000011510 cancer Diseases 0.000 description 1
- OKTJSMMVPCPJKN-BJUDXGSMSA-N carbon-11 Chemical compound [11C] OKTJSMMVPCPJKN-BJUDXGSMSA-N 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000002591 computed tomography Methods 0.000 description 1
- 230000001143 conditioned effect Effects 0.000 description 1
- 230000021615 conjugation Effects 0.000 description 1
- 230000002596 correlated effect Effects 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 238000003745 diagnosis Methods 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 238000013399 early diagnosis Methods 0.000 description 1
- 230000008030 elimination Effects 0.000 description 1
- 238000003379 elimination reaction Methods 0.000 description 1
- 238000001704 evaporation Methods 0.000 description 1
- 230000008020 evaporation Effects 0.000 description 1
- 238000003682 fluorination reaction Methods 0.000 description 1
- KRHYYFGTRYWZRS-BJUDXGSMSA-M fluorine-18(1-) Chemical compound [18F-] KRHYYFGTRYWZRS-BJUDXGSMSA-M 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 239000007789 gas Substances 0.000 description 1
- 125000004029 hydroxymethyl group Chemical group [H]OC([H])([H])* 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 150000002500 ions Chemical class 0.000 description 1
- 238000002372 labelling Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 230000000926 neurological effect Effects 0.000 description 1
- 230000000269 nucleophilic effect Effects 0.000 description 1
- 230000000771 oncological effect Effects 0.000 description 1
- QVGXLLKOCUKJST-BJUDXGSMSA-N oxygen-15 atom Chemical compound [15O] QVGXLLKOCUKJST-BJUDXGSMSA-N 0.000 description 1
- 230000007170 pathology Effects 0.000 description 1
- 229960001179 penciclovir Drugs 0.000 description 1
- 238000011165 process development Methods 0.000 description 1
- 239000002287 radioligand Substances 0.000 description 1
- 238000012776 robust process Methods 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 230000009897 systematic effect Effects 0.000 description 1
- 229940056501 technetium 99m Drugs 0.000 description 1
- 230000001960 triggered effect Effects 0.000 description 1
- 239000002351 wastewater Substances 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01T—MEASUREMENT OF NUCLEAR OR X-RADIATION
- G01T7/00—Details of radiation-measuring instruments
- G01T7/005—Details of radiation-measuring instruments calibration techniques
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
- C07B59/00—Introduction of isotopes of elements into organic compounds ; Labelled organic compounds per se
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
- C07B59/00—Introduction of isotopes of elements into organic compounds ; Labelled organic compounds per se
- C07B59/008—Peptides; Proteins
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16B—BIOINFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR GENETIC OR PROTEIN-RELATED DATA PROCESSING IN COMPUTATIONAL MOLECULAR BIOLOGY
- G16B5/00—ICT specially adapted for modelling or simulations in systems biology, e.g. gene-regulatory networks, protein interaction networks or metabolic networks
Landscapes
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- High Energy & Nuclear Physics (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Physics & Mathematics (AREA)
- Physics & Mathematics (AREA)
- Molecular Biology (AREA)
- Spectroscopy & Molecular Physics (AREA)
- Nuclear Medicine (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Measurement Of Radiation (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161541246P | 2011-09-30 | 2011-09-30 | |
| US201161541246P | 2011-09-30 | ||
| PCT/US2012/057930 WO2013049577A1 (en) | 2011-09-30 | 2012-09-28 | Calibration and normalization systems and methods for radiopharmaceutical synthesizers |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2562656T3 true ES2562656T3 (es) | 2016-03-07 |
Family
ID=47178861
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES12787173.9T Active ES2562656T3 (es) | 2011-09-30 | 2012-09-28 | Sistemas de calibración y normalización y métodos para sintetizadores radiofarmacéuticos |
Country Status (7)
| Country | Link |
|---|---|
| US (1) | US9523778B2 (enExample) |
| EP (1) | EP2760808B1 (enExample) |
| JP (1) | JP6018637B2 (enExample) |
| CN (1) | CN103958445B (enExample) |
| AU (1) | AU2012315757B9 (enExample) |
| ES (1) | ES2562656T3 (enExample) |
| WO (1) | WO2013049577A1 (enExample) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB201418897D0 (en) | 2014-10-23 | 2014-12-10 | Univ Hull | Methods and apparatus for the analysis of compounds |
| GB201418893D0 (en) | 2014-10-23 | 2014-12-10 | Univ Hull | Monolithic body |
| GB201418899D0 (en) * | 2014-10-23 | 2014-12-10 | Univ Hull | System for radiopharmaceutical production |
| US10245002B2 (en) * | 2017-08-01 | 2019-04-02 | Siemens Medical Solutions Usa, Inc. | Isotope specific calibration of a dose calibrator for quantitative functional imaging |
| CA3093236C (en) * | 2018-03-07 | 2022-04-12 | Siemens Medical Solutions Usa, Inc. | Calibration bias reduction in a pressurized gas ion chamber-based dose calibrator |
| SG11202009326XA (en) * | 2018-03-28 | 2020-10-29 | Bracco Diagnostics Inc | Early detection of radioisotope generator end life |
| GB201805283D0 (en) * | 2018-03-29 | 2018-05-16 | Ge Healthcare Ltd | Method of synthesizing a radiopharmaceutical |
| US11615882B2 (en) | 2018-11-07 | 2023-03-28 | Ge Healthcare Limited | Apparatus, non-transitory computer-readable storage medium, and computer-implemented method for distributed ledger management of nuclear medicine products |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DK1620373T3 (da) | 2003-05-07 | 2008-07-28 | Bayer Schering Pharma Ag | Apparat og fremgangsmåde til nucleofil fluorering |
| SE0301508D0 (sv) * | 2003-05-23 | 2003-05-23 | Goergen Nilsson | Method for pre treatment verification in intensity modulates radiation therapy |
| US20070040115A1 (en) * | 2005-08-05 | 2007-02-22 | Publicover Julia G | Method for calibrating particle beam energy |
| US9056200B2 (en) * | 2008-06-06 | 2015-06-16 | Bayer Medical Care Inc. | Apparatus and methods for delivery of fluid injection boluses to patients and handling harmful fluids |
| US8214159B2 (en) | 2008-12-04 | 2012-07-03 | Siemens Medical Solutions Usa, Inc. | Apparatus and method for automated quality control |
| GB0905328D0 (en) * | 2009-03-27 | 2009-05-13 | Ge Healthcare Ltd | Indole derivatives |
| JP6078463B2 (ja) * | 2010-04-09 | 2017-02-08 | バイエル・ヘルスケア・エルエルシーBayer HealthCare LLC | 放射性医薬品の濃度測定システムおよび方法 |
-
2012
- 2012-09-28 CN CN201280059332.6A patent/CN103958445B/zh active Active
- 2012-09-28 WO PCT/US2012/057930 patent/WO2013049577A1/en not_active Ceased
- 2012-09-28 EP EP12787173.9A patent/EP2760808B1/en active Active
- 2012-09-28 US US14/348,189 patent/US9523778B2/en active Active
- 2012-09-28 JP JP2014533396A patent/JP6018637B2/ja active Active
- 2012-09-28 AU AU2012315757A patent/AU2012315757B9/en active Active
- 2012-09-28 ES ES12787173.9T patent/ES2562656T3/es active Active
Also Published As
| Publication number | Publication date |
|---|---|
| CN103958445B (zh) | 2015-12-09 |
| JP2015504412A (ja) | 2015-02-12 |
| US9523778B2 (en) | 2016-12-20 |
| AU2012315757A9 (en) | 2018-02-01 |
| AU2012315757B9 (en) | 2018-01-25 |
| US20140243500A1 (en) | 2014-08-28 |
| CN103958445A (zh) | 2014-07-30 |
| EP2760808B1 (en) | 2015-11-18 |
| WO2013049577A1 (en) | 2013-04-04 |
| AU2012315757B2 (en) | 2017-11-23 |
| EP2760808A1 (en) | 2014-08-06 |
| JP6018637B2 (ja) | 2016-11-02 |
| AU2012315757A1 (en) | 2014-04-17 |
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