Oncology

VirtualScopics is an industry recognized scientific leader in the field of imaging for oncology drug development. Our semi-automated approach provides highly reproducible measurements of both structural and functional tumor endpoints. In a typical oncology study employing imaging, the industry standard is to provide 1 and 2 dimensional assessments (RECIST/WHO) which measure tumor diameter. However, VirtualScopics also conducts 3D, or volumetric, measurements of tumors and we provide all assessments for the same price others charge for only 1D and 2D analysis.

Depending on the study, these unique 3D measurements may include tumor blood flow, tissue to blood volume, oxygen utilization and glucose metabolism, just to name a few. Recent literature and study findings suggest that tumor volumetric measurements (i.e. 3D assessments) provide a more sensitive and likely more accurate assessment of tumor burden and response to therapy. This enables our sponsors to make faster decisions with greater confidence resulting in more efficient, cost effective, and flexible clinical trials.

Using modalities such as DCE-MRI, diffusion MRI and PET, we are able to measure early anti-cancer effects at the cellular level helping to provide more predictive data to increase the power and efficacy of clinical trials. Our analysis has been proven to track and provide quantitative readouts of drug effectiveness on a tumor in days versus months with traditional analysis. This greatly increases clinical trial efficiency, can enable more efficient enrolling and de-enrolling of subjects and shorten the duration of a study, all leading to enormous cost savings for sponsors.

We've incorporated this science into our operations platform to effectively manage oncology trials across all phases of drug development. To date we have conducted nearly 140 projects studying over 40 different disease areas.

Oncology Biomarkers:

  • Vascular Perfusion (DCE-MRI, DCE-CT) - establishes PK/PD relationship, demonstrates early efficacy for anti-angiogenic/anti-vascular compounds
  • Tumor Volume - more reliable, biologically meaningful measure of tumor response
  • Tumor Metabolism (FDG-PET) - provides early signs of response to treatment with close linkage to survival
  • Cell Proliferation (FLT-PET) - assesses tumor mitotic activity
  • RECIST/WHO (Solid Tumor) - a conventional measure of tumor response
  • Cheson (Lymphoma)
  • Macdonald (Glioma)

Response Assessment in Oncology Registration Trials

While novel biomarkers can be of great value in early phase trials, later phase trials rely upon a more standardized set of measurements. The established/accepted criteria for response assessment in oncology registration trials are as follows:

  • Solid tumors: RECIST
    • Summed longest diameters
    • Subjective evaluation of non-target lesions
  • Lymphoma: Cheson
    • Summed product of diameters
    • Separate evaluation of spleen, liver nodules
    • Subjective evaluation of FDG-PET
    • Subjective evaluation of non-target lesions
  • Glioma: Macdonald
    • Summed product of diameters
    • Accounts for steroid use and neurological findings
© VirtualScopics 2012