National Cancer Institute.

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In addition, a quantitative standardized uptake value (SUV) measurement, which represents the maximum SUV (SUVmax), should also be documented for this lesion. The study cohort consisted of 12 well-documented, NHL patients, eight male, four female, ranging in age from 40 to 80 years, who were a subset of patients enrolled in an Institutional Review Board (IRB)-approved early-phase, commercially-sponsored, clinical trial.19 All patients signed written informed consents acknowledging all aspects of the clinical trial including an independent review of their imaging data. The categories for initial staging are defined in this article.

0000010196 00000 n Graham MM, Wahl RL, Hoffman JM, et al. seer.cancer.gov [homepage on the Internet]. Lugano 2014 criteria for assessing FDG-PET/CT in lymphoma: An operational approach for clinical trials June 2017 Drug Design, Development and Therapy Volume 11:1719-1728 Epub 2017 May 5. The assessment of BM according to the Lugano 2014 criteria is also very different from the Cheson 2007 criteria, since BM biopsy (BMB) is no longer required for all patients with FDG-avid lymphomas. • FDG-PET-CT Standard staging for FDG-avid lymphomas Response assessment in FDG-avid subtypes using the 5-point scale • Progressive disease evaluation PPD progression of single site defines progression. One possible solution to this challenge is to raise the threshold for assessing PMD to allow for greater changes in immune-related FDG metabolic activity. Cheson BD, Ansell S, Schwartz L, et al. The objective of this validation was to determine if the proposed Lugano workflow is a feasible method to improve the reproducibility and efficiency amongst readers evaluating the radiographic response in lymphoma patients. The participating IRBs included Schulman Associates IRB, St John Hospital and Medical Center IRB, and New England IRB. 0000011839 00000 n

2015;56(6):955–961.

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. J Nucl Med. The SUVmax will be used to calculate the change in uptake compared to post-baseline TPs. It has 4 stages, labeled I, II, III, and IV. 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 … The overall findings are consistent with a significant partial metabolic response.Abbreviations: NHL, non-Hodgkin’s lymphoma; CT, computed tomography; PET, positron emission tomography; FDG, [18F] fluorodeoxyglucose; 5PS, 5-point scale. 2012;2012:397–401. Accessed May 9, 2017. For example, if five lesions are being followed and only one is observed to have markedly increased uptake compared to the liver, then the overall 5PS score for that TP is 5, regardless of the uptake in the other four lesions. •  Terms & Conditions   A score of 4 or 5 with an increase of >50% is considered a significant increase in FDG uptake, representative of progressive metabolic disease (PMD), and a change metric between ≤25% decrease and ≤50% increase in FDG uptake is considered to be no significant change in FDG uptake, representative of no metabolic response.

Surveillance, Epidemiology, and End Results Program. 0000004254 00000 n

Challenges to developing an operational reader workflow paradigm for clinical trials. Copyright 2017 Informa PLC. Fleiss JL, Cohen J. 2014;32(27):3048–3058. J Clin Oncol.

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In the Cheson 2007 criteria, these lesions which changed from FDG-positive to FDG-negative following treatment, regardless of residual size on CT, were designated as a complete response. FDG-PET assessment at baseline and on-study TPs.

CT (left image) reveals diffuse adenopathy in the neck and mediastinum (white arrows). These differences are yielding important insights into the natural biology of lymphoma, as well as potential markers for diagnostic and therapeutic development. Accessed May 9, 2017. seer.cancer.gov [homepage on the Internet].

Barrington SF, Mikhaeel NG. From editorial acceptance to publication. The designation of “X” in the Lugano 2014 5PS has been removed, since under the proposed operational workflow, the readers are trained to provide a comment in their assessment if there are new areas of observed uptake that are unlikely to be lymphoma.

These lesions must meet the minimum size requirement of being >15 mm in longest diameter (LDi) for nodal disease, or >10 mm in LDi for extranodal lesions. This approach is reproducible with a high concordance rate between individual readers (kappa 0.73 [confidence interval 0.59–0.87; P=<0.0001]) using a 5-point scale to assess [18F] labeled fluorodeoxyglucose metabolic activity in lymphomatous lesions. 2016;128(21):2489–2496. ]��b>��(棜�b>��(棜�b>��(�c��a>F��o��F��o��F��o��F��o��F��o��F��l�UE�޺\r��uŌ��g��0�?���]����&�6s�;�}���~����l�~��[q��.��;�+� �5g endstream endobj 120 0 obj <> endobj 121 0 obj <> endobj 122 0 obj <>stream Accessed May 9, 2017. At on-study TPs, CT index and non-index lesions were assessed for continued presence of disease, however, no size measurements or change metrics were required.

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