18F-FDG PET as a candidate for 'qualified biomarker': functional assessment of treatment response in oncology.

摘要

In this issue, The Journal of Nuclear Medicine publishes National Cancer Institute (NCI) guidelines that are a step on the path toward qualifying 18F-FDG PET as a biomarker to assess treatment response during NCI-sponsored trials. These guidelines, written by Shankar et al. (i), were developed in recognition of the growing use of 18F-FDG PET in clinical trials sponsored by the NCI and of the importance of standardizing methodology for such use. Broad representation was obtained in the drafting of these guidelines by including PET experts throughout the country, as well as representatives from the U.S. Food and Drug Administration and Center for Medicare Studies.