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espanolIntroduccion y objetivos Dado que los diferentes escaneres de PET/TC (tomografia por emision de positrones/tomografia computarizada) dan lecturas cualitativas diferentes, es obligatorio un programa de cualificacion de ensayos clinicos (CTQ) para garantizar un uso fiable y reproducible de la PET/TC en ensayos clinicos prospectivos multicentricos. Dentro de este trabajo mostraremos los resultados en la realizacion de CTQ en Espana. Materiales y metodos Hemos puesto en marcha, bajo los auspicios del Grupo Espanol de Linfomas/Trasplante Autologo de Medula Osea (GELTAMO), un programa de CTQ que consiste en la adquisicion y analisis de fantomas de uniformidad 18F y calidad de imagen para la reduccion de la variabilidad interescaner (ISV). La ISV se estimo sobre la concentracion de actividad de fondo (BAC) y la relacion esfera a fondo (SBR) y se definio como su intervalo de confianza (IC) del 95%. Resultados Veintiseis de los 27 escaneres (96%) cumplieron los requisitos de la CTQ. El CTQ se cumplio en la primera ronda en el 27% de los casos, mientras que en el 38%, 15% y 20% se requirieron dos, tres o mas de tres iteraciones, respectivamente. El tiempo medio de la CTQ fue de 1,8 ± 1,4 meses (rango: 0,3-4,6). El ISV en BAC y SBR fue 20,3 y 67,7%. Conclusiones El CTQ demostro ser una herramienta fiable para reducir la ISV. Esto permitio poner en marcha ensayos clinicos en los que se utilizo la PET/TC para evaluar diferentes criterios de valoracion clinica. EnglishIntroduction and objectives Since different PET/CT (Positron Emission Tomography/Computed Tomography) scanners give different qualitative readings, a program for clinical trial qualification (CTQ) is mandatory to guarantee a reliable and reproducible use of PET/CT in prospective multi-centre clinical trials. Within this work we will show the results carried out in performing CTQ in Spain. Materials and methods We set up, under the auspices of Grupo Espanol de Linfomas/Trasplante Autologo de Medula Osea (GELTAMO), a CTQ program consisting of the acquisition and analysis of 18F uniformity and image quality phantoms for the reduction of inter-scanner variability (ISV). The ISV was estimated on background activity concentration (BAC) and sphere to background ratio (SBR) and defined as their 95% confidence level. Results Twenty-six out of 27 (96%) scanners fulfilled the CTQ requirements. The CTQ was fulfilled at the first round in 27% of the cases, while in 38%, 15% and 20%, two, three or more than three iterations, were required, respectively. The mean CTQ time was (1.8 ± 1.4) months (range: 0.3-4.6). The ISV in BAC and SBR were 20.3% and 67.7%. Conclusions The CTQ proven to be a reliable tool to reduce ISV. This enabled to set-up clinical trials in which PET/CT was used to evaluate different clinical endpoints.

Introduction and Objectives Since different PET/CT (Positron Emission Tomography/Computed Tomography) scanners give different qualitative readings, a program for clinical trial qualification (CTQ) is mandatory to guarantee a reliable and reproducible use of PET/CT in prospective multi-centre clinical trials. Within this work we will show the results carried out in performing CTQ in Spain. Materials and Methods We set up, under the auspices of Grupo Espanol de Linfomas/Trasplante Autologo de Medula Osea (GELTAMO), a CTQ program consisting of the acquisition and analysis of 18 F uniformity and image quality phantoms for the reduction of inter-scanner variability (ISV). The ISV was estimated on background activity concentration (BAC) and sphere to background ratio (SBR) and defined as their 95% confidence level. Results Twenty-six out of 27 (96%) scanners fulfilled the CTQ requirements. The CTQ was fulfilled at the first round in 27% of the cases, while in 38%, 15% and 20%, two, three or more than three iterations, were required, respectively. The mean CTQ time was (1.8 ± 1.4) months (range: 0.3–4.6). The ISV in BAC and SBR were 20.3% and 67.7%. Conclusions The CTQ proven to be a reliable tool to reduce ISV. This enabled to set-up clinical trials in which PET/CT was used to evaluate different clinical endpoints.