Oncology

FDG-PET and DCE-MRI in oncology

Novel imaging modalities to support clinical endpoints

There are more clinical trials underway in oncology than in any other therapeutic area. Imaging has an established role in these trials, but current tumour diameter measurement methods are considered too insensitive for many compounds in development.

The well established diagnostic imaging techniques of positron emission tomography together with F-18-deoxyglucose (FDG-PET) and dynamic contrast enhanced magnetic resonance imaging(DCE-MRI) both show great promise as biomarkers of drug efficacy in oncology trials. Publicly funded consensus building projects and qualification trials are underway.

For use in clinical trials, both FDG-PET and DCE-MRI must be performed longitudinally and in a quantitative manner, which is different from their standard clinical use in healthcare.

IXICO has the know-how, technology and partnerships to devise appropriate acquisition protocols for studies involving PET and DCE-MRI imaging. We also undertake site qualification to minimize test-retest variability and trial management (including initial and on-going QA/QC), train technologists, and perform sensitive image analysis customized to requirements of the sponsor.

Acquisition Design: IXICO provides extensive PET and MRI acquisition know-how and image analysis expertise.

Project Management: Working closely with sites to ensure strict protocol compliance, accurate and fast data transfer and quick response to site queries is pivotal in successfully managing multi-center trials. IXICO performs on-site training and qualification for sophisticated imaging methods, with on-going scanner QC, trouble-shooting and regular site communication.

Analysis: IXICO's semi-automated workflows, characterized by quality enforcement, include standardizing reconstruction techniques between vendors for FDG-PET and maximizing sensitivity for DCE-MRI through interframe and between visit alignment.

Visibility: Real-time progress reports are available to the sponsor via web a interface to IXICO's results management system. This provides secure access to fully anonymised image data, both original and processed.

Output: Complete analysis of SUV measurements for FDG-PET and pharmacokinetic parameters for DCE-MRI is provided back to the sponsor in a format to meet specific needs.

IXICO works within an ISO 9001:2008 certified Quality Management System, with the provenance of the image analysis results stored to provide a complete and compliant electronic audit trail.