@article {Sunderland1737, author = {John Sunderland and Paul Christian and Tina Kiss}, title = {PET/CT scanner validation for clinical trials-reasons for failure, recipes for success: the Clinical Trials Network (CTN) experience.}, volume = {56}, number = {supplement 3}, pages = {1737--1737}, year = {2015}, publisher = {Society of Nuclear Medicine}, abstract = {1737 Objectives Phantom validation of quantitative accuracy and image quality of a PET/CT scanner is often the first step in site qualification for clinical trial participation. The SNMMI CTN has analyzed over 400 scanner validations performed with the CTN oncology phantom. Of these submissions, 20\% of studies fail to pass acceptance criteria. The objective of this retrospective study is to identify and classify the reasons for failure to better prepare sites for qualification and to aid in site selection.Methods Records from 421 phantom scans submitted to CTN between 2009 and 2014 were reviewed to identify causes of failures. Seven categories for failure were tallied: 1) Missing information; 2) Phantom filling and activity measurement; 3) Data entry; 4) Scanner calibration/dose calibrator; 5) Image quality/lesion detectability; 6) PET/CT misalignment; 7) Image artifacts. Each site was classified as {\textquotedblleft}academic{\textquotedblright} or {\textquotedblleft}non-academic{\textquotedblright} based on the availability of full-time on-site physics support.Results 170 imaging sites performed the 421 phantom scans reviewed. 41\% of sites were classified as academic and 59\% non-academic. Academic sites failed scanner validation 12\% of the time, but all passed on rescan. Non-academic sites failed validation 31\% of the time, and with some frequency also failed rescan. The most frequent failure (42\% of all errors, 10\% of all phantom scans) was due to technical errors in phantom filling, imaging, or reconstruction. The 2nd most frequent failure was unacceptable scanner calibration (27\% of all errors, 6\% of all phantom scans). The frequency distribution of error category (1-7) was nearly identical between academic and non-academic sites.Conclusions Non-academic sites suffered disqualifying errors at nearly 3-times the rate of academic sites. Executing technical instructions for phantom filling and imaging proved the most significant challenge. The results suggest that academic sites have a higher probability of first-pass validation success than their non-academic counterparts.Research Support None}, issn = {0161-5505}, URL = {https://jnm.snmjournals.org/content/56/supplement_3/1737}, eprint = {https://jnm.snmjournals.org/content}, journal = {Journal of Nuclear Medicine} }