CNS

Structural Change assessment in longitudinal brain imaging studies

Tracking disease progression in dementia

IXICO utilises the most trusted and the most current atrophy quantification techniques available to accurately assess brain atrophy as a biomarker for numerous neurological disorders.

Brain volume loss is an established down-stream effect of progressive neurodegenerative diseases, such as Alzheimer’s disease, Huntington’s disease, and multiple sclerosis. Modern MRI methods provide better resolution, contrast and signal to noise ratios than the established methods for atrophy quantification, making it possible to provide higher sensitivity to change. This has resulted in the extensive use of MR imaging to obtain atrophy measurements that can serve as a biomarker for these diseases in both natural history studies and clinical trials of new drugs.

Algorithms to measure atrophy are very sensitive to subtle changes in image properties and to artifacts caused by subject motion, scanner instability, or poor subject positioning. Standardizing the acquisition protocol between sites is imperative to the success of the trial, Site monitoring is necessary at each site for the duration of the trial, providing attention to detail that is substantially beyond standard clinical practice.
•    Atrophy measurements have been shown to distinguish between normal aging and dementia, but their use to assess therapy effects is still emerging. There is a need to match the imaging measurements to the expected action of the drug.
•    Some novel therapies for dementias such as AD have potential side-effects such as micro-bleeds. Imaging also has the potential to provide safety biomarkers for these methods.
•    The most trusted and the most current atrophy quantification techniques must be used to accurately assess brain atrophy as a biomarker for neurodegenerative disorders

IXICO Solutions
IXICO is an Imaging CRO providing end to end imaging solutions for clinical trials.  We provide expert image analysis technology that uses sensitive and reproducible algorithms to quantify changes over time. The technology we use can compensate for the misplacement or movement of a patient in the scanner, compare images taken at different time points and provide a full audit trial of the analysis process. Our unique quality control system enables better site specific methods for rapid detection of protocol violations or poor data quality.

IXICO’s  has a proven track record, Clients include a number of the top 10  pharmaceutical and healthcare companies for whom IXICO designs bespoke services.

Acquisition Design: Our expertise in imaging systems means that we have the knowledge to optimize sequences across all major scanner vendors, specific to the study. We consider subject stability, image quality and suitability of sequences for image analysis

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.

Quality Control: Our approach to image QC involves ensuring that images are of high quality both generally and also specifically related to the endpoints that will be measured in the study. We believe this approach enables significantly better results from the image analysis phase.

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 interface to IXICO’s results management system.  This provides secure access to fully anonymised image data, both original and processed.

Output: Global and local structural change measurements from the longitudinal studies are provided back to the sponsor in a a format to meet your specific needs.

Scope: IXICO provides end to end imaging solutions for trials from early phase exploratory work to full scale, late phase trials. Our expertise includes MRI, CT, PET and other modalities.

IXICO works within an ISO9001:2000 certified Quality Management System, with the provenance of the image analysis results stored to provide a complete electronic audit trail.