Drug Design, Development and Therapy (Jun 2017)

Lugano 2014 criteria for assessing FDG-PET/CT in lymphoma: an operational approach for clinical trials

  • Van Heertum RL,
  • Scarimbolo R,
  • Wolodzko JG,
  • Klencke B,
  • Messmann R,
  • Tunc F,
  • Sokol L,
  • Agarwal R,
  • Strafaci JA,
  • O'Neal M

Journal volume & issue
Vol. Volume 11
pp. 1719 – 1728

Abstract

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Ronald L Van Heertum,1 Robert Scarimbolo,1 John G Wolodzko,1 Barbara Klencke,2 Richard Messmann,3 Feza Tunc,4 Levi Sokol,4 Rajan Agarwal,5 James A Strafaci,1 Michael O’Neal1 1Medical Affairs, Bioclinica, Inc., Princeton, NJ, 2Medical Affairs, Sierra Oncology, Brisbane, CA, 3Medical Affairs, Apexian Pharmaceuticals, Indianapolis, IN, 4Radiology, University Radiology at RWJ University Hospital, New Brunswick, NJ, 5Radiology, Abington Hospital, Abington, PA, USA Abstract: An operationalized workflow paradigm is presented and validated with pilot subject data. 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. These results suggest an operationally practical 5-point scale workflow paradigm for potential use in larger clinical trials evaluating lymphoma therapeutics. Keywords: lymphoma, Lugano criteria, molecular imaging, oncology trials 

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