From the June 2017 issue of HealthCare Business News magazine
By Robert Nordstrom and Hyunsuk Shim
Clinical trials are used to determine the safety and efficacy of drugs prior to FDA approval and market entry.
The success of such trials depends on the organization of the trial, the protocols used, and the ability to predict the drug response and measure accurate final outcomes. In cancer studies, imaging methods have long been a noninvasive means to estimate therapeutic response at specific time points during a trial. The advent of quantitative methods to extract information from clinical images has significantly refined and improved the role of imaging as a reliable tool in clinical trial measurements. The degree of variability arising from uncertainty in scanner quality, image acquisition, processing and analysis degrades the data quality and requires more patient accrual, and can lead to inconclusive results. This translates directly into additional costs for drug development. Going beyond the simple RECIST linear measurements of tumor size, quantitative imaging is now capable of defining tumor volume, heterogeneity, metabolic activity, entropy and other measures of staging.
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PET is a quantitative functional imaging technique and a powerful method for assessing early response to new cancer therapies in multi-center clinical trials. Unfortunately, the reliability of this quantitative information is degraded by substantial variability. The addition of CT and the development of more sophisticated instrumentation, reconstruction and compensation methods has improved accuracy, but the physical variations between systems from different vendors and institutions is a problem. Scanner manufacturers compete in the marketplace by promoting improvements in image quality and ease of operation without serious consideration of quantitative reliability. This leads to variations in measurement bias and variance between the instrument manufacturers and even within individual scanner overtime.
If we were to achieve a prominent role in building multi-site clinical trial productivity through quantitative imaging, it is essential to resolve the lack of calibration/standardization among imaging scanners. In 2008, the NCI established the Quantitative Imaging Network (QIN) to bring together research teams nationally to find solutions. In another effort supported by the NCI, several academic research groups have joined forces with the major PET/CT scanner manufacturers and SNMMI to generate standard calibration methods using a NIST traceable 68Ge/68Ga phantom. The SNMMI Clinical Trials Network (CTN) has designed a PET/CT phantom imaging program to validate scanners across sites. To date, hundreds of scanners from all major vendors have been tested using the phantom.