Standardisation and harmonisation boost the credibility of nuclear medicine procedures

Abstract

The results of diagnostic procedures in nuclear medicine may be heavily influenced by the equipment used and factors related to the investigator. The freedom of physicists, technicians and physicians to discretely compose the camera set-up and the protocols for acquisition, reconstruction and post-processing, including various techniques of quantification, not surprisingly results in a heterogeneous outcome of procedures that are in principle the same. One might debate whether these issues play a role in the diagnostic work-up of a certain patient; it is quite evident, however, that scientific investigations, e.g. in the setting of multicentre trials, may be greatly compromised by these factors. Procedural guidelines published by professional associations in our field, such as the European Association of Nuclear Medicine (EANM), the Society of Nuclear Medicine (SNM) or the local societies in various European countries are an important milestone to provide a basic framework. However, it is in the nature of such guidelines that they leave space for interpretation and layout. Particularly for scientific purposes but also in the clinical context standardisation and harmonisation of procedures needs to be further pursued and developed to improve the comparability of results between institutions. The credibility of reported findings depends largely on their validity. The latter is a crucial point, because nuclear medicine procedures increasingly have to prove both benefit for the patient and economic benefit before they are accepted and recognized by health insurance and authorities. In this context procedural guidelines have to be further narrowed with the aim of providing harmonised, wellaccepted results. An example of how these theoretical considerations can be successfully realised is supplied by John Dickson and co-workers. They report in this issue of the European Journal of Nuclear Medicine and Molecular Imaging a proposal for the standardisation of SPECT investigations of the brain for multicentre trials [1]. This proposal is the first logical step of a remarkable programme launched and developed under the umbrella of the recently founded EANM Research Ltd (EARL) and aims to standardise investigations with I-123-FP-CIT (DaTSCAN) SPECT in Europe. FP-CIT is a diagnostically valuable tracer for assessment of presynaptic dopaminergic function, particularly in neurodegenerative Parkinsonian syndromes. Unfortunately however, even though this radiopharmaceutical has been approved for more than a decade in Europe in clinical practice as well as in clinical trials, the quality spectrum of scans has ranged from excellent to rather poor, mostly due to the lack of standardised acquisition, processing, and quantification and of a generally available reference database. Realising these problems, the Neuroimaging Committee of the EANM decided to initiate a programme to overcome these limitations by setting up an investigatorinitiated multicentre trial using EARL as a platform. The aims of the trial, performed at 15 highly experienced centres in ten European countries, were threefold: first, to provide a framework to acquire high-quality multicentre SPECT studies by proposing a standardised set-up and qualityassurance regime; second, to perform anthropomorphic phantom measurements for cross-calibration of gamma camera systems; and third, to build up a comprehensive K. Tatsch (*) Klinik fur Nuklearmedizin, Stadtisches Klinikum Karlsruhe, Moltkestr. 90, 76133 Karlsruhe, Germany e-mail: Klaus.Tatsch@klinikum-karlsruhe.de