for Sponsor Initiated Trials
mint Lesion™ empowers the collection and analysis of imaging and clinical data in clinical trial evaluations with imaging endpoints. This includes the transfer and storage of clinical trial DICOM data, a workflow optimized for consistent interpretation and reviewing of image findings, the quality assurance of image meta-data, and the simplified provision of results to all actors as well as clinical systems, e.g. PACS and Clinical Trial Management Systems. mint Lesion™ thus meets the requirements of a Clinical Trial Image Management System (CTIMS) as defined by the National Cancer Institute (NCI).
By creating a digital signature of each patient case in a structured and reproducible format, mint Lesion™ ensures data quality, integrity, and traceability.
Current pathways to new treatments for patients are affected by a lack of organization, consistency, compliance, and accessibility of both imaging and clinical data. mint Lesion™ remediates these challenges across the clinical trial spectrum while enhancing the valuable contribution clinical research provides to bring safe and efficacious treatments to patients sooner.
mint Lesion™ enables you to ask for more in your clinical trials:
- Access read results earlier for go/no go decisions with a read-ready, compliant, road-tested platform within days of the first patient on study
- Improve flexibility to meet timelines and novel protocol designs through an extensive set of response criteria and the continuous addition of new criteria, including configurable criteria and workflows, multiple read designs and multi-criteria analysis
- Achieve comprehensive data association by linking disease findings with location lexicon (RadLex, SDTM), measurements beyond diameters (volumetrics, SUVs), response assessment, radiomics (1st and 2nd order texture parameter), clinical and epidemiological data – no data is left behind
- Generate reliable, high-quality data – reported in a consistent, compliant, comprehensive, and structured format
- Maximize data alignment, increase data comparability, and minimize discordance between site and central reads
- Export everything, including the images themselves into a connected, mobile, comprehensive, and minable format that allows for real-time data analytics, in-depth investigation and learning
mint Lesion™ allows you to model the needs of your imaging charter by software configuration. Have dedicated medical experts, tasks, workflows, and permissions set up and let mint Lesion™ drive your imaging research – from image quality assurance, eligibility reads, up to patient cohort level data exports, and operational metrics.
Objective Radiological Read
The context-driven read procedures of mint Lesion™ will guide the radiological expert to perform a dedicated assessment in an optimized read context. Significant observations in morphologic and functional image data are documented and classified in adherence to the protocol and tracked throughout treatment. By this means, mint Lesion™ provides the basis for a true objective assessment and minimizes reader variability. Let mint Lesion™ help your readers to speed up their work and focus on their job-to-be-done.
Monitoring & Data Management
Monitoring project progress directly within mint Lesion™ will increase the efficiency of your research work. As one example, corrective actions are managed, performed, and documented in immediate correlation with the image annotations to assure traceability and integrity of your research data. Comprehensive and high quality data is crucial in clinical research. mint Lesion™ generates this data for a single observation on image data up to comprehensive data exports for the entire study cohort. An automated response assessment automatically assigns the time-point response from lesion measurements and classifications to avoid manual calculations.
Achieve high quality research results with mint Lesion™, the only dedicated Clinical Trial Imaging System in line with CFR Part 11, GxP, and HIPAA as approved medical device
(FDA 510k, CE)
Phase 1 Trials
Phase 2 Trials
Phase 3 Trials
Overall approved reads