Accuracy of Dose Calibrators for ⁶⁸Ga PET Imaging: Unexpected Findings in a Multicenter Clinical Pretrial Assessment.

Abstract

We report the discovery of a systematic miscalibration during the work-up process for site validation of a multicenter clinical PET imaging trial using ⁶⁸Ga, which manifested as a consistent and reproducible underestimation in the quantitative accuracy (assessed by SUV) of a range of PET systems from different manufacturers at several different facilities around Australia. <b>Methods:</b> Sites were asked to follow a strict preparation protocol to create a radioactive phantom with ⁶⁸Ga to be imaged using a standard clinical protocol before commencing imaging in the trial. All sites had routinely used ⁶⁸Ga for clinical PET imaging for many years. The reconstructed image data were transferred to an imaging core laboratory for analysis, along with information about ancillary equipment such as the radionuclide dose calibrator. Fourteen PET systems were assessed from 10 nuclear medicine facilities in Australia, with the aim for each PET system being to produce images within 5% of the true SUV. <b>Results:</b> At initial testing, 10 of the 14 PET systems underestimated the SUV by 15% on average (range, 13%-23%). Multiple PET systems at one site, from two different manufacturers, were all similarly affected, suggesting a common cause. We eventually identified an incorrect factory-shipped dose calibrator setting from a single manufacturer as being the cause. The calibrator setting for ⁶⁸Ga was subsequently adjusted by the users so that the reconstructed images produced accurate values. <b>Conclusion:</b> PET imaging involves a chain of measurements and calibrations to produce accurate quantitative performance. Testing of the entire chain is simple, however, and should form part of any quality assurance program or prequalifying site assessment before commencing a quantitative imaging trial or clinical imaging.