Exploring Splenomegaly Assessment in Lymphoma Clinical Trials by Dr. M. Sharma and Imaging Endpoints
In clinical trials evaluating new therapies for lymphoma, the disease assessments are primarily driven by the Lugano Classification 2014 and rely heavily on PET avidity and changes in measurable disease. These objective measures are critical for standardizing evaluations and ensuring consistency across clinical trials. However, splenomegaly plays a significant and often underappreciated role in the overall assessment of lymphoma patients. Insights from Dr. M. Sharma and colleagues at ECR 2025 explored integration of subjective criteria alongside the strictly adhered-to objective metrics to enhance diagnostic accuracy and improve patient outcomes.
The current industry focus necessitates strict adherence to objective criteria across clinical trials, which is essential for establishing clear benchmarks for treatment response. Despite this rigor, the implementation of these criteria is not uniform across different studies, leading to variances in assessments of splenomegaly. While objective measurements are undeniably crucial, they may not capture the complexities of individual patient cases or account for various confounding factors impacting spleen health, such as underlying infections or liver diseases. This gap underscores the need for a more flexible approach that allows for expert judgment in analysis.
At Imaging Endpoints (IE), we are committed to exploring this transformative effort. As presented at ECR 2025, we propose a plan to empower expert readers with greater authority and flexibility in their assessments. By allowing subjective judgment to complement objective criteria, we aim to create a more comprehensive evaluation framework for splenomegaly in lymphoma patients. For instance, considerations such as patient size and the presence of obvious confounding diseases can be crucial in borderline cases of spleen enlargement, where changes in disease status elsewhere may also influence the evaluation of the spleen and overall patient assessment. This dual approach seeks not only to enhance the accuracy of response evaluations but also to ensure that treatment decisions are more reflective of the patient’s unique clinical status.
While objective criteria are critical for lymphoma assessments, recognizing the importance of splenomegaly and allowing for expert discretion can significantly enhance clinical trials. Insights shared at ECR 2025 reaffirm Imaging Endpoints’ commitment to pioneering innovation in oncology research. By valuing both objective data and subjective insights, we ultimately transform treatment approaches and improve patient outcomes in lymphoma care. For more information,
