QUALITY MANAGEMENT AT THE EUROPEAN BNCT CENTER IN PETTEN

Boron Neutron Capture Therapy is based on the ability of the isotope 10B to capture thermal neutrons and to disintegrate instantaneously producing the high LET particles, He and Li nuclei, with a high kinetic energy of about 2.5 MeV and a very short range in tissue of about 10μm [10B(n,α)7Li]. If such reactions can be produced selectively in tumour cells, an effective new modality for cancer treatment would be available. In the 1950’s and early 1960’s, BNCT trials in the USA were effectively a failure.1 Nevertheless, in the late 60’s, Hatanaka in Japan demonstrated that BNCT does benefit patients.2 However, the reported results were difficult to interpret, because the treatment was not carried out in a controlled manner. In 1994, new trials started in the USA (at Brookhaven National Laboratory BNL3 and Massachusetts Institute of Technology MIT4) involving glioblastoma (at BNL and MIT) and melanoma (at MIT). Meanwhile in Europe in the late 1980’s, effective research into introducing BNCT began following the injection of financial support from the Biomedicine and Health Research programme (BIOMED I) of the European Commission. This has lead recently to the start of clinical trials of BNCT for glioblastoma multiforme, with the aim to establish a safe radiation dose for the treatment of brain tumours.5 It is the first time that a clinical application has had to be realised on a real multi-national scale, whereby a unique facility available for BNCT is localised in one country (The Netherlands) and is operated by an international team of experts under the leadership of a German radiotherapist, treating patients coming from different European countries. It was therefore necessary that special structures had to be created with the support of administrations from different countries, who had to find and adapt solutions within existing laws that had never foreseen such a situation.