MEDIAN Technologies (ALMDT), the leading provider of clinical applications for quantitative management of treatment responses in oncology imaging, announced the introduction on the market of its CTIS product – Clinical Trial Imaging Services.
- discordance among the various image readers (24 to 39 % of cases*),
- loss of patients due to missing images (11 to 13 % of cases*),
- enrollment of patients without measurable diseases (up to 9 % of cases*),
reduce the quality and the reliability of clinical trial results, negatively impacting on Go/NoGo decisions, trial duration, and cost. (*European Journal of Cancer 45 (2009) 268-274)
Taking this into account, CTIS is a package of innovative services that optimises the use of medical images in oncology clinical trials. CTIS is targeted to the various stakeholders involved in trials including investigator sites, independent reviewers and sponsors. CTIS provides concrete solutions to frequently-observed imaging problems in oncology clinical trials: variability in image interpretation, censoring bias, difficult implementation of advanced imaging biomarkers, complex workflows and management of image databases.
MEDIAN Technologies CEO Frederik Brag commented that « With CTIS, we have developed an innovative solution for the end-to-end management of oncology clinical trials. This solution is well adapted to the problems encountered by pharmaceutical companies in the context of these clinical trials and has already been adopted by three of the biggest pharmaceutical companies worldwide.”
The CTIS package includes four kinds of services that can be customized per trials:
- Management of investigator sites : site qualification, site training, implementation of infrastructure for onsite image reading, onsite quality control, optimization of imaging data workflow,
- Independent review services, double reading and adjudication,
- Centralized databases and on-demand functionalities, sponsor access : project dashboards, data mining, access to all images and data via MEDIAN LMS
- Advanced reviewing services providing advanced imaging biomarkers.
The CTIS package is based on MEDIAN Technologies LMS (Lesion Management Solutions) that can be used on investigator sites, independent review sites and sponsor sites.
Lesion Management Solutions (LMS) detect, evaluate and follow-up automatically lesions identified in computed tomography (CT) scans. LMS provide response criteria that are utilized for the evaluation of patient response to therapy (such as lesion diameter); they also perform automated measurements of advanced lesion parameters (such as volume, density…), thus allowing the implementation of advanced imaging biomarkers. LMS automation capabilities result in image reading standardization and interpretation variability decrease.
Lesion Management Solutions are compatible with all types of CT scanner. They can be integrated into heterogeneous IT environments and easily deployed at sites with very diverse equipment and software configurations.