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Purpose: Dopamine transporter (DAT) imaging with [I]FP-CIT (DaTSCAN) is an established diagnostic tool in parkinsonism and dementia. Although qualitative assessment criteria are available, DAT quantification is important for research and for completion of a diagnostic evaluation. One critical aspect of quantification is the availability of normative data, considering possible age and gender effects on DAT availability. The aim of the European Normal Control Database of DaTSCAN (ENC-DAT) study was to generate a large database of [I]FP-CIT SPECT scans in healthy controls. Methods: SPECT data from 139 healthy controls (74 men, 65 women; age range 20 - 83 years, mean 53 years) acquired in 13 different centres were included. Images were reconstructed using the ordered-subset expectation-maximization algorithm without correction (NOACSC), with attenuation correction (AC), and with both attenuation and scatter correction using the triple-energy window method (ACSC). Region-of-interest analysis was performed using the BRASS software (caudate and putamen), and the Southampton method (striatum). The outcome measure was the specific binding ratio ( SBR). Results: A significant effect of age on SBR was found for all data. Gender had a significant effect on SBR in the caudate and putamen for the NOACSC and AC data, and only in the left caudate for the ACSC data (BRASS method). Significant effects of age and gender on striatal SBR were observed for all data analysed with the Southampton method. Overall, there was a significant age-related decline in SBR of between 4 % and 6.7 % per decade. Conclusion: This study provides a large database of [I]FP-CIT SPECT scans in healthy controls across a wide age range and with balanced gender representation. Higher DAT availability was found in women than in men. An average age-related decline in DAT availability of 5.5 % per decade was found for both genders, in agreement with previous reports. The data collected in this study may serve as a reference database for nuclear medicine centres and for clinical trials using [I]FP-CIT SPECT as the imaging marker. [ABSTRACT FROM AUTHOR]

123I- N-ω-fluoropropyl-2-β-carboxymethoxy-3β-(4-iodophenyl)nortropane (123I-FP-CIT) Single-photon emission computed tomography (SPECT) has been suggested to be a useful diagnostic adjunct in patients with clinically uncertain parkinsonism. We developed a pharmaco-economic (PE) model, evaluating the cost effectiveness of adding 123I-FP-CIT SPECT to the diagnostic workup. As the model was developed before application of the diagnostic technique in real practice, a predictive validity assessment was performed based on data from a large nationwide patient registry in these patients. A PE model, using a Markov state transition model, was created, based on literature-derived and clinical expert panel data. Effects were expressed as adequately treated years (ATY). Key input data were compared to the real-life patterns in a nationwide multi-centre clinical setting, based on a complete national registry of 1,701 consecutive patients. The change in initial diagnosis and alteration of management of the patient after SPECT were registered. In the PE model, it was calculated that management would change in 48.5% of patients by SPECT and that, over a 5-year period, 1.2 ATYs could be gained at a yearly additional cost of €72. From the studied 1,701 patients, nigrostriatal degeneration was observed in 59.8%, the initial diagnosis was changed in 51.5%, management was altered in 49%, and cost effectiveness was increased to €358 per ATY. Good correspondence between assumed and observed changes in patient management was found, indicating that 123I-FP-CIT SPECT is influential in diagnosis and management of patients with uncertain clinical diagnosis of parkinsonism. This can be achieved at a marginal added cost to the health insurance and leads to a significant gain in ATY. [ABSTRACT FROM AUTHOR]

As healthcare expenses are escalating in many countries, the sector faces a new challenge of becoming more cost efficient. There is an urgent need for more accurate data on the costs of healthcare procedures. The cost of Positron Emission Tomography (PET) with [18F]-fludeoxyglucose (18F-FDG) studies is mainly influenced by the price of the radiopharmaceutical, which may vary throughout Europe from 300 to 500 Euro per patient dose (370 MBq). The aim of the current study is to conduct an activity-based costing (ABC) estimation of 18F-FDG production in Europe to better identify the different cost components and to analyse their relative contribution to the total cost. Financial data were collected on capital expense and global operating costs through interviews with industry experts, PET centre managers, evaluation of prior studies, and review of expenses incurred at the University Medical Centre in Groningen (The Netherlands). After mapping the activities, we divided the cost in five categories: wage, equipment, consumables, overhead and space costs. A sensitivity analysis was performed for key cost components, including the compliance with regulatory requirements. The critical factor for profitability was throughput. Including the European regulation procedure, the cost for 370 MBq 18F-FDG patient dose, 3 h EOS without delivery cost, ranges between 155 and 177 Euro/dose for two production runs and between 210 and 237 Euro/dose for one production run. These costs are predominantly determined by personnel and equipment costs, although the cost for quality assurance increases steadily. The ABC analysis provides significant insight into the production cost components of 18F-FDG through different operating configurations. Reductions in equipment prices, increased availability of radiopharmaceuticals, growth in demand, and improvements in reimbursement will all contribute to the financial viability of this imaging technique. [ABSTRACT FROM AUTHOR]