Another potential challenge with the implementation of the Lugano 2014 criteria is in immunotherapy oncology clinical trials, where the observation of increased metabolic activity may be mistakenly interpreted as PMD. This methodology ensures that all sites of disease, which are reflective of the patient’s overall tumor burden, are accounted for in each TP assessment. Staging and response assessment in lymphomas: the new Lugano classification. NIH •  Associations & Partners   This approach should allow for a more accurate early assessment of lymphoma tumor treatment response, however, there is still some controversy in the literature regarding the use of interim PET assessment of treatment response in the clinical trial setting.14,15 While the new criteria should reduce the subjective variability which has existed in regards to determination of FDG-PET lesion positivity, this observation has yet to be documented in any multi-center lymphoma clinical trials. Furthermore, it is possible to eliminate bone marrow biopsies in patients with Hodgkin lymphoma and diffuse large B-cell lymphoma. An alternative approach for controlling against sudden increases in FDG uptake which may be due to immune-related metabolic activity, is to delay the confirmation of PMD until a subsequent imaging TP (approximately 6–12 weeks after the initial observation of PMD) is submitted and the initial assessment of PMD can be either confirmed or not confirmed by the reader. All selected sites of disease should be followed throughout the course of treatment. •  Testimonials   Volume 2017:11 Pages 1719—1728, Editor who approved publication: Although the PET criteria in Lugano 2014 for FDG-avid lymphomas do not specifically require the designation of index and non-index disease and size measurements on CT, this approach allows investigators to follow all disease in a logical manner, where the PET findings can be easily correlated with CT imaging and clinical observations. The Lugano classification is a lymphoma staging system for non-Hodgkin and Hodgkin lymphoma. 0000002270 00000 n National Center for Biotechnology Information, Unable to load your collection due to an error, Unable to load your delegates due to an error. Graham MM, Wahl RL, Hoffman JM, et al. Rinsho Ketsueki. 10 Our goal was to develop a reproducible and time-efficient operational paradigm, utilizing the Lugano 2014 criteria, which could be routinely employed in clinical drug trials … 0000005902 00000 n Comprehensive reader training for an individual lymphoma clinical trial using the Lugano 2014 criteria, should be based on the presumption that the readers already have in-depth experience and knowledge of the radiographic assessment of lymphomatous disease and the Lugano 2014 criteria.