iRECIST Criteria: An Operational Approach in Oncology Clinical Trials

Life Sciences, Clinical Trials,
  • Thursday, July 16, 2020

As immunotherapies continue to evolve, the assessment of disease progression can be challenging to distinguish from the immune response. The concept of immune response and its manifestations on medical imaging can have an impact on determining the course of treatment for the patient. The iRECIST criteria aims to reduce the ambiguity of this issue by implementing new evaluation methods for documenting and confirming disease progression. The goal of this webinar is to discuss an operational approach for using the iRECIST criteria in support of oncology clinical trials. The methodology for documenting various imaging data points including establishment and confirmation of progression will be elucidated.


(Moderator) Julie Cole, M.D., VP, Medical Imaging, Oncology, Bioclinica

Julie Cole (formerly Julie Barudin) received a B.S.E. in Electrical Engineering and Computer Science (cum laude) from Princeton University, and an M.D. from the College of Physicians and Surgeons of Columbia University. She completed a residency in diagnostic radiology at New York University Medical Center, with fellowships in Body Imaging and Women’s Imaging. She is licensed in New Jersey, New York, Pennsylvania and Delaware and board certified by the American Board of Diagnostic Radiology.

Following training, Dr. Cole served as Assistant Professor of Radiology, Ultrasound Division, at NYU Medical Center, and subsequently as Assistant Professor of Radiology, Breast Imaging Division, at the University of Pennsylvania School of Medicine. Before joining BioClinica in 2004, she worked in clinical women’s imaging at Hackensack University Medical Center and at Orange Regional Medical Center where she served as Director of Women’s Imaging.

She has contributed to presentations at the RSNA, and has co-authored articles published in Breast Disease and Preventive Medicine journals as well as chapters on breast imaging for multiple radiology textbooks.

Message Presenter

Rob Scarimbolo, Senior Director, Medical & Scientific Affairs, Bioclinica

Rob Scarimbolo is the senior director of medical affairs for the oncology division at Bioclinica. He is responsible for developing processes to support and manage several imaging projects, including document development, radiologist networking, training and image analysis software methods. Scarimbolo aims to create solutions for various imaging read criteria in support of diagnostic and efficacy oncology clinical trials. He collaborates with Bioclinica’s radiologists, oncologists, software development, project and data management teams to help design and execute deliverables in the oncology space. He began his career at Bioclinica (formerly CoreLab Partners) in 2007 as a clinical project coordinator and has held numerous roles of increasing responsibility within the global clinical operations department. Robert earned his BSc in Health Sciences from Stony Brook University in New York.

Message Presenter

Zachary LaVoie, Medical & Scientific Affairs Sr. Manager, Bioclinica

Zachary LaVoie is a medical and scientific affairs sr. manager at Bioclinica within the oncology division. He is responsible for analyzing sponsor protocols and defining reading criteria, read design/workflow and independent reader training. One of the main tasks of LaVoie’s position is reviewing and identifying the gaps within oncologic response criteria, with the purpose that the criteria can be applied accurately and consistently for the clinical trial. Additional responsibilities include devising processes to support and manage imaging projects, including image analysis software validation and enhancement. LaVoie began his career at Bioclinica (formerly CoreLab Partners) in 2011 as a clinical project coordinator and, before transitioning to Medical Affairs, had most recently worked as a clinical project manager, where he was responsible for managing over 20 Global Phase I-III studies across various indications and response criteria. LaVoie earned his BA in Biology from McDaniel College in Maryland.

Message Presenter

Who Should Attend?

  • Medical Monitors
  • Clinical Scientists
  • Imaging Scientists
  • Clinical Development, Clinical Research, Clinical Operations
  • Study/Project Manager
  • Protocol Manager
  • Data Management

What You Will Learn

Join this webinar to learn about:

  • Concepts of establishing iUPD and iCPD by category (target, non-target and new lesions)
  • Data scenarios across imaging time point visits
  • Image case examples demonstrating observations using the criteria
  • Common challenges and how they can be handled

Xtalks Partner


Bioclinica is a global, life-science provider that utilizes science and technology to bring clarity to clinical trials – helping companies to develop new, life-improving therapies more efficiently and safely. The company’s offerings include medical imaging and cardiac safety services; clinical adjudication; randomization and trial supply management and optimization; electronic and eSource data capture; site and patient payments and budget forecasting; pharmacovigilance, and trial management.

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