18FDG synthesis and supply: a journey from existing centralized to future decentralized models.

Positron emission tomography (PET) as the functional component of current hybrid imaging (like PET/ CT or PET/MRI) seems to dominate the horizon of medical imaging in coming decades. 18Flourodeoxyglucose (18FDG) is the most commonly used probe in oncology and also in cardiology and neurology around the globe. However, the major capital cost and exorbitant running expenditure of low to medium energy cyclotrons (about 20 MeV) and radiochemistry units are the seminal reasons of low number of cyclotrons but mushroom growth pattern of PET scanners. This fact and longer half-life of 18F (110 minutes) have paved the path of a centralized model in which 18FDG is produced by commercial PET radiopharmacies and the finished product (multi-dose vial with tungsten shielding) is dispensed to customers having only PET scanners. This indeed reduced the cost but has limitations of dependence upon timely arrival of daily shipments as delay caused by any reason results in cancellation or rescheduling of the PET procedures. In recent years, industry and academia have taken a step forward by producing low energy, table top cyclotrons with compact and automated radiochemistry units (Lab- on-Chip). This decentralized strategy enables the users to produce on-demand doses of PET probe themselves at reasonably low cost using an automated and user-friendly technology. This technological development would indeed provide a real impetus to the availability of complete set up of PET based molecular imaging at an affordable cost to the developing countries.

Effective use of a new quality and safety checklist for the steady and safe supply of fluorine-18 fluorodeoxyglucose for positron emission tomography/computed tomography.

Fluorine-18-fluorodeoxyglucose ((18)F-FDG ) positron emission tomography/computed tomography (PET/CT) with the in-hospital synthesis of (18)F-FDG was initiated in our hospital on April 1, 2010. We aim to perform stable supply of (18)F-FDG for patients and to avoid unnecessary radiation exposure due to mis-preparation of (18)F-FDG. Pharmacists perform quality control tests to determine whether (18)F-FDG meets official regulations. After the quality control test, we give (18)F-FDG that conforms to these standards to patients to conduct (18)F-FDG PET/CT. After a quality control test is initiated, various problems can occur including leakage and staff radiation exposure. We recorded daily radiation exposure in the hot lab and calculated the average daily radiation exposure on a monthly basis for a period of one year. We developed a checklist to safely and quickly synthesize(18)F-FDG for patients. The total radiation exposure of the three pharmacists was 394, 180, and 214µSv/y and overall lower than the occupational maximum values (≤50mSv/year and ≤100mSv/5years for males). In conclusion, using the new checklist, pharmacists and the operator of the Sumitomo Heavy Industries Accelerator service Co., Ltd. were able to practice their daily work effectively during the synthesis and quality control testing of (18)F-FDG. Notably the usual radiation exposure reported in the present study was quite lower than the allowable maximum.

[Clinical PET activities in European and Asia-Oceanian countries].

Clinical diagnosis using positron emission tomography (PET) requires high costs. Therefore, sociomedical evaluation is very important for spread of clinical PET. In this report, sociomedical situation in European and Asia-Oceanian countries, especially concerning transportation of 18F-FDG and reimbursement of medical costs for clinical PET indications, is reported. It seems that UK, Germany and Belgium are the most advanced in clinical PET in Europe. In these countries, many PET investigations are reimbursed though systems are different among the countries. In UK, both public and private insurance gives authorization for clinical PET to some extent. In Germany, private health insurance companies give authorization but public insurance has not. In Belgium, private health insurance does not exist and public insurance gives authorization for clinical PET. Other European countries seem to be in transitional stages. Transportation of 18F-FDG has been already started in almost every country in Europe and Asia-Oceania. In Japan, neither transportation of FDG nor full reimbursement of clinical PET has not started yet and this situation seems to be exceptional. To promote clinical PET in Japan, there is the need of at least establishing a list of clinical indications for PET investigations and establishing commercial-based 18F-FDG supplying system. They could be regarded as a kind of infrastructure for spread of clinical PET.