FDG-PET and FDG production at Wattanosoth
Main Article Content
Abstract
FDG-PET or Positron Emission Tomography with Fluorode- oxyglucose (fluorine-18-2-fluoro-2-deoxy-D-glucose [FDG]) for oncologic imaging both detects and effectively monitors the therapy of many malignancies. FDG-PET improves the detection and staging of cancer, disease management, therapy selection, and the assessment of appropriate therapeutic responses. Besides the use of FDG-PET in oncology, it can also be used in neurology and cardiology. The clinical use of FDG-PET has flourished over the past 15 years. This article is not meant to be exhaustive, but rather to give an overview and to share some information and experience of FDG-PET and FDG production at Wattanosoth Hospital. It will touch briefly on all aspects of FDG-PET and its production, namely an overview of radioisotope production of F-18, FDG synthesis and quality control.
Article Details
This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
References
2. Reivich M, Kuhl D, Wolf A, et al. The [18F]fluorodeoxy- glucose method for the measurement of local cerebral glucose utilization in man. Circ Res 1979;44:127-37.
3. Kostakoglu L, Agress H, Goldsmith SJ. Clinical role of FDG PET in evaluation of cancer patients. Radio- Graphics 2003;23:315-40.
4. Gallagher BM, Fowler JS, Gutterson NI, et al. Metabolic trapping as a principle of radiopharmaceutical design: some factors responsible for the biodistribution of [18F] 2-deoxy-2-fluoro-D-glucose. J Nucl Med 1978;19:1154-61.
5. Hoh K, Howkins RA, Glaspy JA, et al. Cancer detection with whole-body PET using [F-18]fluoro-2-deoxy-D-glu- cose. J Comput Assist Tomogr 1993;17:582-9.
6. Delbeke D. Oncological Applications of FDG PET imaging. J Nucl Med 1999;40:1706-15.
7. Fletcher JW, Djulbegovic B, Soares HP, et al. Recommen- dations on the Use of 18F-FDG PET in Oncology. J Nucl Med 2008;49:480-508.
8. Von Schulthess GK, Steinert HC, Hany TF. Integrated PET/CT: current applications and future directions. Radi- ology 2006;238:405-22.
9. Medicare National Coverage Determinations Manual. Chapter 1, Part 4 (Sections 200-310.1)(Rev. 146, 08-03- 12)Available at http://www.cms.gov/Regulations-and- Guidance/Guidance/Manuals/downloads/ncd103c1_ Part4.pdf[Access December 16, 2012.]
10. Buck AK, Herrmann K, Stargardt T, et al. Economic Eval- uation of PET and PET/CT in Oncology: Evidence and Methodologic Approaches. J Nucl Med Tech 2010;38:6-17.
11. Review of PET services in Hong Kong hospital author- ity. Part 2—Programming and service rationalization. Release Date June 2012. Available at http://www.ha.org. hk/haho/ho/adm/210576e.pdf[Access December 17, 2012].
12. The Royal College of Radiologists. PET-CT in the UK, A strategy for development and integration of a leading edge technology within routine practice. 2005; Available at http://www.rcr.ac.uk/docs/general/pdf/PETCT_final. pdf[Access December 17, 2012].
13. Martinuk SD. The Use of Positron Emission Tomography (PET) for Cancer Care Across Canada Time for a National Strategy. 2011; AAPS, Inc. and TRIUMF.
14. Funding arrangements for diagnostic imaging services, an international literature review. 2009 Available at https:// www.health.gov.au/internet/main/publishing.nsf/Content/ DA4840C15CF15F0CCA2576D300019741/$File/ ACIL%20TASMAN%20Final%20Report%20-%20 International%20Funding%20Models%20for%20 Diagnostic%20Imaging.pdf[Access December 18, 2012].
15. International Commission on Radiological Protection. Radiation Dose to Patients from Radiopharmaceuticals. St.Louis, MO:2000;49. ICRP publication 80.
16. Delbeke D, Coleman RE, Guiberteau MJ, et al. Procedure Guidline for Tumor Imaging with 18F-FDG PET/CT 1.0. J Nucl Med 2006;47:885-95.
17. International Atomic Energy Agency (IAEA), Cyclotron Produced Radionuclides: Principles and practice, Technical Reports Series No. 465, IAEA, Vienna, 2008.
18. International Atomic Energy Agency (IAEA), Cyclotron Produced Radionuclides: Guidelines for setting up a facility, Technical Reports Series No. 471, International Atomic Energy Agency (IAEA), Vienna, 2009.
19. Jacobson MS, Hung JC, Mays TL, Mullan BP. The plan- ning and design of a new PET radiochemistry facility. Mol Imaging Biol 2002;4:119-27.
20. IAEA, Cyclotron Produced Radionuclides: Guidance on Facility Design and Production of [18F]Fluorodeoxyglu- cose (FDG), IAEA radioisotopes and radiopharmaceuti- cals series No.3, IAEA, Vienna, 2012.
21. Stafford RG. Code of Practice for the Design of Laborato- ries using Radioactive Substances for Medical Purposes, Commonwealth of Australia, Australian Government Publishing Service, Canberra 1981; Appendix XVIII.
22. World Health Organization, Annex 3: Guidelines on Good Manufacturing Practices for Radiopharmaceutical Products, WHO Technical Report Series, No. 908, WHO, Geneva, 2003.
23. European Union, EudraLex: The Rules Governing Medic- inal Products in the European Union, Volume 4, EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Annex 3: Manu- facture of Radiopharmaceuticals, Brussels, September, 2008.
24. US Food and Drug Administration, Department of Health and Human Services, 21 CFR Part 212 Current Good Manufacturing Practice for Positron Emission Tomogra- phy Drugs.
25. Fowler JS, Ido T. Initial and subsequent approach for the synthesis of 18FDG. Semin Nucl Med 2002;32:6-12.
26. Levy S, Elmaleh DR, Livni E. A new method using anhydrous [18F]fluoride to radiolabel 2-[18F]fluoro-2- deoxy-D-glucose. J Nucl Med 1982;23:918-22.
27. Hamacher K, Coenen HH, Stocklin G. Efficient stereo- specific synthesis of no-carrier-added 2-[18F]-fluoro-2- deoxy-D-glucose using aminopolyether supported nucleo- philic substitution. J Nucl Med 1986;27:235-8.
28. Yu S. Review of 18F-FDG synthesis and quality control.Biomed Imaging Interv J 2006;2:e57.
29. International Pharmacopoeia, Monograph: Fludeoxyglu- cose (18F) Injection, International Pharmacopoeia, 2008.
30. European Pharmacopoeia, Monograph: Fludeoxyglucose (18F) Injection, European Pharmacopoeia Ed. 6, 2009.
31. US Pharmacopoeia, Monograph: Fludeoxyglucose18F Injection, US pharmacopoeia, 2009.
32. International Atomic Energy Agency (IAEA), Guidelines for Good Manufacturing Practices of Radiopharmaceuticals, IAEA, Vienna, 2001.
33. The European Pharmacopoeia (Ph.EUR): The European GMP Guidelines for Medicinal Products for Human Use. Annex 1: Manufacture of Sterile Products and Annex 3. Manufacture of Radiopharmaceuticals.
34. Canadian Health Products and Food Branch Inspectorate, Positron Emitting Radiopharmaceuticals (PER), Annex to the Good Manufacturing Practices (GMP) Guidelines, Guide-0071, February 15, 2006.