MRI-based response criteria have been widely used in glioma clinical trials over the past decade. However, anatomical MRI is often limited by ambiguity in tumor extent, including non-enhancing disease. It can also be difficult to distinguish post-treatment effects such as pseudoprogression or radionecrosis from true tumor progression. In addition, standard MRI protocols do not capture metabolic tumor activity, limiting insight into underlying tumor biology.
Amino-acid PET imaging enables metabolic assessment of tumor activity and has emerged as an important complementary tool in neuro-oncology research. In this webinar, MERIT provides an overview of PET RANO 1.0, a consensus framework developed to standardize metabolic response and progression assessment in diffuse glioma using PET imaging. We will discuss how standardized PET-based metrics can be applied in clinical research and oncology trials.
3 key questions that are answered:
- What limitations exist with MRI-based response assessment in diffuse glioma clinical trials?
- What are the fundamental concepts and metabolic metrics underlying PET RANO 1.0?
- How can PET RANO 1.0 be applied to support consistent metabolic response assessment in clinical trials?
Gene Kim, PharmDASSOCIATE DIRECTOR OF MEDICAL AFFAIRS & INNOVATION, ONCOLOGY
Gene is MERIT’s Associate Director of Medical Affairs & Innovation for our oncology division. He provides subject matter expertise and helps design and configure MERIT’s flexible oncology reading platform to accommodate various reading paradigms. Gene has experience in evidence-based patient care and academic research, a background in pharmacy, and 6 years supporting clinical trials. He implements software workflows to support oncology trials with response criteria such as RECIST 1.1, iRECIST, Lugano, and RANO, and helps to increase the efficiency and accuracy of clinical data collection for imaging endpoints. Gene received his Doctor of Pharmacy (Pharm.D.) from the University of Wisconsin-Madison and has a bachelor’s degree in Neurobiology.
Veronika Matsuk, PhDOncology Clinical Scientist
Veronika’s background is in academic cancer biology and translational research. She supports oncology clinical studies by applying biological and scientific insight to imaging interpretation, response assessment frameworks, and the evaluation of clinically meaningful endpoints. Her work bridges academic research concepts with the practical and operational considerations of clinical trial design and execution.
Catherine Chintala, PMPDIRECTOR OF OPERATIONS, ONCOLOGY
With over 20 years of experience working in clinical operations at CROs and imaging core labs, Catherine has expertise managing oncology clinical trials from start up to close out. She works closely with Sponsors, designing and implementing processes to meet project timelines while helping to ensure study needs are clearly communicated across key stakeholders. Catherine’s background also includes Sponsor governance, managing KPIs, and standardizing processes for teams and departments to run more efficiently. Drawing upon her experience in a variety of indications and response criteria, Catherine can partner with your team to help make your clinical trial a success.