Quality control management of clinical PET/CT cancer trials

Objectives Using investigator initiated and multi-institutional PET/CT oncology trials, we performed an analysis of all components from protocol preparation to endpoint assessment identifying critical challenges and areas of non-compliance

Methods A quality control (QC) process was implemented in a standardized operating procedure (SOP) driven environment adhering to good practice guidelines. The process components include: trial protocol development, equipment validation, investigator and staff training, patient recruitment, acquisition compliance, data transfer, data management, data analysis, and reader performance. A semi-automatic software environment was developed to facilitate mega data processing and to generate automatic QC reports. All steps of the clinical trial process are regularly audited and documented with verification to protocol guidelines

Results A total of 309 patients with 831 examinations from over 50 sites are included in this assessment. The most common protocol violation has been non-compliance with the time between injection and initiation of emission scanning (~33%). The 2^nd most common area of non-compliances are inconsistencies between the baseline and follow-up studies such as: emissions timing (~22%), arm positioning (<5%), and scan direction (<5%). Other non-compliances are: blood glucose level (<5%), prior medication (<5%) as well as data format (<5%) and completeness (<5%)

Conclusions Understanding the real world challenges in clinical imaging trials enables the development of more robust protocols by identifying the areas impacting compliance. Appropriate training and qualification of the team performing clinical trials, leads to the highest levels of compliance