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

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

Received 14 March 2017

Accepted for publication 2 May 2017

Published 13 June 2017 Volume 2017:11 Pages 1719—1728

DOI https://doi.org/10.2147/DDDT.S136988

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Rasika Samarasinghe

Peer reviewer comments 2

Editor who approved publication: Dr Tuo Deng

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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Companion diagnostics and molecular imaging-enhanced approaches for oncology clinical trials

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Published Date: 11 September 2015