Detecting Myocarditis in Oncology Trials with Imaging

Advanced imaging techniques can be used to assess for myocarditis (which has been reported with immune checkpoint inhibitors) before initiating cancer therapy, as well as for monitoring during and after treatment.

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Customizing Clinical Trial Imaging to Support a Claim: A Case Study

When it comes to clinical trial imaging, a one-size-fits-all approach just doesn’t work. Creative problem-solving and scientific expertise are critical to meeting each sponsor’s unique needs. Here we review how Medtronic captured the data they needed to demonstrate product superiority by relying on ERT’s advanced imaging technology and scientific expertise.

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Documentation in Imaging Clinical Trials: Its Importance and Recent Regulatory Changes

This article provides an overview of why documentation is critical to the success of medical imaging in clinical trials and summarizes a few key terminology updates resulting from the recent FDA Guidance for Industry with respect to clinical trial imaging endpoint process standards. Read this third installment to our medical imaging clinical trials series now.

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Navigating the Response Assessment Criteria for Lymphoma

Learn how recent changes to the standard treatment response criteria used in lymphoma clinical trials ─ including new biomarkers and different imaging methods ─ are enabling more accurate and effective patient assessment and management.

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Why Inject Additional Risks into Clinical Trials?

At a time when researchers are seeking to improve efficiencies in the clinical development process, it’s mind-boggling that some are still using outdated, and in many cases, manual approaches to collect, aggregate, and report clinical trial data. Here we present how automated, centralized solutions can streamline operations, improve study efficiencies and yield better results through two examples: electronic Clinical Outcome Assessments (eCOA) and advanced, technology-driven imaging.

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How Personalized Medicine is Challenging Medical Imaging Teams: The Keytruda Example

With the 2017 approval of Merck’s Keytruda, the FDA has opened the door to novel oncologic treatments that truly are at the forefront of personalized medicine. In what is becoming a new era of cancer treatments, researchers must understand how to best design and operationalize an oncology trial to gain regulatory approval. Discover how this new treatment approach will drive big changes for oncologists, as well as for medical imaging teams.

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