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DCE-MRI Biomarkers Technology and Development

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  • 19 Jul
Following on from my recent post on Optical Coherence Tomography, another interesting medical imaging technology that I am actively involved with is Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI). DCE-MRI is an imaging technique that combines the magnetic field and radio frequency imaging of MRI with the injection into a vein of a standard MRI contrast media that makes organs, tumors and blood vessels easier to see. Essentially DCE-MRI provides the tracking of low molecular weight contrast agents through blood vessels, in particular the vasculature of tumors. By analyzing the pharmacokinetics of the contrast agent into a specific tumor, it is possible to measure alterations in vascular permeability, blood flow and extracellular volumes. This is of interest in the development of cancer drugs that inhibit new blood vessel formation (anti-angiogenesis) or disrupt existing blood vessels (vascular disrupting agents) for example. O’Connor et al in the British Journal of Cancer provides a good review of DCE-MRI imaging biomarkers in oncology clinical trials.
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Imaging Biomarkers in Oncology Clinical Trials

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  • 15 Jul

Following on in my series of blog posts about imaging biomarkers and the recent BioClinica symposium, I wanted to share some insights provided by Ali Guermazi, MD (a consultant to BioClinica, who was also a co-author on the Cheson Criteria) from Boston University School of Medicine who spoke on “Imaging Biomarkers in Oncology from RECIST to beyond.”

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Imaging Biomarkers in Clinical Trials

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  • 06 Jul
Imaging biomarkers are currently a “hot topic” in pharmaceutical circles. This was brought into focus at a recent symposium in Princeton and repeated in Amsterdam on “Current and Innovative Imaging Biomarkers in Neurology and Oncology Drug Development.”At this symposium, BioClinica brought together several leading experts and key opinion leaders to present on emerging imaging biomarker trends. Cornelis van Kuijk (Professor and Chair Department of Radiology, Vrije Universiteit Medical Center, Amsterdam) provided an informative introduction to imaging biomarkers in clinical trials. He started off his presentation by saying: “Imaging biomarkers should reflect disease activity and are used to study natural course of disease and to study interventions for treatment such as medication.”
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Best Practices for Applying Electronic Signatures When Using EDC

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  • 01 Jul

Electronic Signature Application Questions

There is quite a bit of information by the FDA and others about what it means to apply an electronic signature.

Here are the questions around electronic signatures that I hear most often:

  • Should the electronic signature be applied to all pages in the electronic CRF?
  • Should the electronic signature be applied to Adverse Events, and Study Completion as typically done on paper? 
  • Should electronically transmitted laboratory data be electronically signed?
  • What happens if pages are electronically signed and the data changes? 
  • What if a page is electronically signed, then a query is added to the page?
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