Lymphoma Trial Using Lugano Classification

Challenge

In lymphoma trials, treatment decisions and endpoint determinations rest on metabolic response classification, yet Deauville scoring is notoriously variable when performed at individual sites. Wide divergence in site-level scoring had made complete metabolic response classifications difficult to trust, threatening the integrity of the trial's response-based endpoints and complicating the planned interim analysis. The sponsor required a central review process that could impose genuine consistency on an inherently subjective assessment.

Our Solution

Intrinsic Imaging engaged nuclear medicine physicians to perform blinded dual assessments of every FDG PET/CT examination under the Lugano 2014 classification. SUV calibration was verified for each submission to ensure quantitative comparability across scanners, and any disagreement in Deauville scoring between the two primary readers was resolved through formal adjudication. This structure converted a subjective site-level judgment into a controlled, documented, and reproducible central determination.

Results

• Consistent response classification across participating sites
• Adjudication rate held below 12%
• Reconciled central review dataset delivered for interim analysis