Imaging Opportunities for Advancing Treatment Evaluation in Glioma Clinical Trials
Gliomas are the most common type of malignant primary brain tumor. Imaging is crucial in diagnosing gliomas and evaluating treatment responses. Proper application and customization of the RANO and RAPNO criteria for each unique clinical trial, including criteria clarifications and modifications as applicable, are critical to clinical trial success.
The Response Assessment in Neuro-Oncology (RANO) Working Group published response criteria for high-grade gliomas (RANO-HGG) in 2010, and low-grade gliomas (RANO-LGG) in 2011. The RANO criteria emphasizes changes in bi-dimensional contrast-enhancing tumor size in order to define response, while also incorporating the neurological status and corticosteroid treatment of the patient. Due to difficulties in distinguishing pseudoprogression caused by radiochemotherapy and immunotherapy from true progression, Immunotherapy RANO (iRANO) and Modified RANO (mRANO) were developed to address these limitations.
Recently published RANO 2.0 recommendations have been guided in part by the results of a study comparing RANO-HGG, mRANO, and iRANO in 526 patients with newly diagnosed glioblastoma and 580 patients with recurrent glioblastoma treated with both conventional therapies and on clinical trials. It is critical to understand enhancing and non-enhancing disease while implementing these criteria to ensure proper findings and trial outcomes.
While the RANO criteria have been pivotal in assessing adult high-grade gliomas, the newly established RAPNO criteria address the unique challenges of evaluating pediatric gliomas, emphasizing the need for tailored imaging and clinical assessment strategies. As emphasized by Martin Waits, Associate Director at Imaging Endpoints, “embracing innovative endpoints and imaging methods in Glioma clinical trials can significantly improve treatment strategies”. Additionally, by incorporating advanced imaging techniques and quantitative radiomics, we can deepen our understanding of treatment responses beyond conventional criteria.
Note that published criteria may not include all the details required to fully execute the analysis for each unique trial. IE delineates criteria clarifications and/or modifications for each trial. Clarifications list details that are aligned with the criteria and its intent but are not adequately specified in the publication. Modifications list changes to the criteria that are not fully aligned with the publication or its intent.
With a strong track record of improving trial outcomes by implementing the right strategy, our team specializes in optimizing imaging charter and assessment criteria for Glioma clinical trials including being a pioneer for utilizing RANO & RAPNO for regulatory submissions and approvals.
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