title: Retrospective quality control review of FDG scans in the imaging sub-study of PALETTE EORTC 62072/VEG110727: a randomized, double-blind, placebo-controlled phase III trial.
abstract: OBJECTIVE
  (18)F-Labelled fluorodeoxyglucose (FDG) can detect early changes in tumour metabolism and may be a useful quantitative imaging biomarker (QIB) for prediction of disease stabilization, response and duration of progression-free survival (PFS). Standardization of imaging procedures is a prerequisite, especially in multicentre clinical trials. In this study we reviewed the quality of FDG scans and compliance with the imaging guideline (IG) in a phase III clinical trial.
  
  
  METHODS
  Forty-four cancer patients were enroled in an imaging sub-study of a randomized international multicentre trial. FDG scan had to be performed at baseline and 10-14 days after treatment start. The image transmittal forms (ITFs) and Digital Imaging and Communications in Medicine (DICOM) [1] standard headers were analysed for compliance with the IG. Mean liver standardized uptake values (LSUVmean) were measured as recommended by positron emission tomography (PET) Response Criteria in Solid Tumors 1.0 (PERCIST) [2].
  
  
  RESULTS
  Of 88 scans, 81 were received (44 patients); 36 were properly anonymized; 77/81 serum glucose values submitted, all but one within the IG. In 35/44 patients both scans were of sufficient visual quality. In 22/70 ITFs the reported UT differed by >1 min from the DICOM headers (max. difference 1 h 4 min). Based on the DICOM, UT compliance for both scans was 31.4%. LSUVmean was fairly constant for the 11 patients with UT compliance: 2.30 ± 0.33 at baseline and 2.27 ± 0.48 at follow-up (FU). Variability substantially increased for the subjects with unacceptable UT (11 patients): 2.27 ± 1.04 at baseline and 2.18 ± 0.83 at FU.
  
  
  CONCLUSIONS
  The high attrition number of patients due to low compliance with the IG compromised the quantitative assessment of the predictive value for early response monitoring. This emphasizes the need for better regulated procedures in imaging departments, which may be achieved by education of involved personnel or efforts towards regulations. LSUVmean could be monitored to assess quality and compliance in an FDG PET/CT study.
authors.affiliation: European Organization for Research and Treatment of Cancer Headquarters, Brussels, Belgium, ivalinahr@gmail.com.
authors.forename: Ivalina
authors.initials: I
authors.lastname: Hristova
authors.forename: Ronald
authors.initials: R
authors.lastname: Boellaard
authors.forename: Wouter
authors.initials: W
authors.lastname: Vogel
authors.forename: Felix
authors.initials: F
authors.lastname: Mottaghy
authors.forename: Sandrine
authors.initials: S
authors.lastname: Marreaud
authors.forename: Sandra
authors.initials: S
authors.lastname: Collette
authors.forename: Patrick
authors.initials: P
authors.lastname: Schöffski
authors.forename: Roberta
authors.initials: R
authors.lastname: Sanfilippo
authors.forename: Raz
authors.initials: R
authors.lastname: Dewji
authors.forename: Winette
authors.initials: W
authors.lastname: van der Graaf
authors.forename: Wim J G
authors.initials: WJ
authors.lastname: Oyen
mesh_terms: D017326:Clinical Trials, Phase III as Topic; D019788:Fluorodeoxyglucose F18 / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D015337:Multicenter Studies as Topic; D049268:Positron-Emission Tomography / Q000379:methods / Q000592:standards*; D011786:Quality Control; D019275:Radiopharmaceuticals / Q000592:standards*; D016032:Randomized Controlled Trials as Topic; D012509:Sarcoma / Q000000981:diagnostic imaging*; D012983:Soft Tissue Neoplasms / Q000000981:diagnostic imaging*
chemical_list: D019275:Radiopharmaceuticals; D019788:Fluorodeoxyglucose F18