title: The (68)Ge phantom-based FDG-PET site qualification program for clinical trials adopted by FIL (Italian Foundation on Lymphoma).
abstract: OBJECTIVE
  The quantitative assessment of Positron Emission Tomography (PET) scans using standardized uptake value and derived parameters proved to be superior to traditional qualitative assessment in several retrospective or mono-centric prospective reports. Since different scanners give different quantitative readings, a program for clinical trial qualification (CTQ) is mandatory to guarantee a reliable and reproducible use of quantitative PET in prospective multi-centre clinical trials and in every-day clinical life.
  
  
  METHODS
  We set up, under the auspices of Italian Foundation on Lymphoma (FIL), a CTQ program consisting of the PET/CT scan acquisition and analysis of (18)F and (68)Ge NEMA/IEC image quality phantoms for the reduction of inter-scanner variability. Variability was estimated on background activity concentration (BAC) and sphere to background ratio (SBR).
  
  
  RESULTS
  The use of a (68)Ge phantom allowed reducing the inter-scanner variability among different scanners from 74.0% to 20.5% in BAC and from 63.3% to 17.4% in SBR compared to using the (18)F phantom. The CTQ criteria were fulfilled at first round in 100% and 28% of PET scanners with (68)Ge and (18)F respectively.
  
  
  CONCLUSIONS
  The (68)Ge phantom proved a reliable tool for PET scanner qualification, able to significantly reduce the potential sources of error while increasing the reproducibility of PET derived quantitative parameter measurement.
authors.affiliation: Santa Croce e Carle Hospital, Cuneo, Italy. Electronic address: chauvie.s@ospedale.cuneo.it.
authors.forename: Stephane
authors.initials: S
authors.lastname: Chauvie
authors.affiliation: Santa Croce e Carle Hospital, Cuneo, Italy.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Bergesio
authors.affiliation: Arcispedale Santa Maria Nuova-IRCCS, Reggio Emilia, Italy.
authors.forename: Federica
authors.initials: F
authors.lastname: Fioroni
authors.affiliation: University Hospital Maggiore della Carità, Novara, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Brambilla
authors.affiliation: Santa Croce e Carle Hospital, Cuneo, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Biggi
authors.affiliation: Arcispedale Santa Maria Nuova-IRCCS, Reggio Emilia, Italy.
authors.forename: Annibale
authors.initials: A
authors.lastname: Versari
authors.affiliation: San Gerardo Hospital, Monza, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Guerra
authors.affiliation: IRCCS-CROB, Referral Cancer Center of Basilicata, Rionero in Vulture (Pz), Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Storto
authors.affiliation: IRCCS-CROB, Referral Cancer Center of Basilicata, Rionero in Vulture (Pz), Italy.
authors.forename: Pellegrino
authors.initials: P
authors.lastname: Musto
authors.affiliation: Department of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia, Modena, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Luminari
authors.affiliation: Businco Hospital, Cagliari, Italy.
authors.forename: Maria G
authors.initials: MG
authors.lastname: Cabras
authors.affiliation: Humanitas Cancer Centre, Rozzano, Italy.
authors.forename: Monica
authors.initials: M
authors.lastname: Balzarotti
authors.affiliation: AOU Careggi Hematology Department, Firenze, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Rigacci
authors.affiliation: University "Sapienza" Roma, Department of Cellular Biotechnologies and Hematology, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Martelli
authors.affiliation: Città della Salute Hospital, Torino, Italy.
authors.forename: Umberto
authors.initials: U
authors.lastname: Vitolo
authors.affiliation: Department of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia, Modena, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Federico
authors.affiliation: A. Lacassagne Cancer Center, Nice, France.
authors.forename: Andrea
authors.initials: A
authors.lastname: Gallamini
mesh_terms: D002138:Calibration; D002986:Clinical Trials as Topic / Q000592:standards*; D004867:Equipment Design; D019788:Fluorodeoxyglucose F18 / Q000737:chemistry; D005857:Germanium / Q000737:chemistry*; D006801:Humans; D007091:Image Processing, Computer-Assisted; D008223:Lymphoma / Q000000981:diagnostic imaging*; D015337:Multicenter Studies as Topic; D018579:Patient Selection; D019047:Phantoms, Imaging; D000072078:Positron Emission Tomography Computed Tomography; D049268:Positron-Emission Tomography; D011868:Radioisotopes / Q000737:chemistry*; D015203:Reproducibility of Results; D012189:Retrospective Studies
chemical_list: D011868:Radioisotopes; D005857:Germanium; D019788:Fluorodeoxyglucose F18
keywords: Clinical trials; Lymphoma; Positron emission tomography; Quantitative imaging