Imaging can assess therapeutic efficacy of a new treatment and is an important part of the solution to reduce costs and improve timeliness of clinical trials. Key aspects for delivery of an imaging clinical trial is the design of the optimal imaging protocol that both patient friendly but at the same time generates imaging biomarkers which give the new compounds a competitive edge and clear differentiation from competition. Secondly, the use of electronic image management system and in most cases the cloud-based infrastructure to improve the quality of data collection, standardization and the analysis while reducing the cost. Lastly, selection of the right image analysis methods and reader training to allow for as much automation in the collection of measurements as possible. This helps to reduce errors and human effort, computer-aided image data and measurements are more likely to be reproducible, more sensitivity and less expensive.
Image Analysis works with broad range of imaging modalities for a variety of therapeutic areas giving our clients access to the best clinical data while minimizing overall study risk. We support a comprehensive range of medical imaging modalities including
- MRI, including contrast dynamic MRI, DWI and ADC
- X-Ray and CT, including contrast CT
- PET and SPECT
Imaging Data Collection and Sharing
Images for clinical trials should be collected using uniform image acquisition methods to minimize the variability. Our team has a great deal of hands-on experience dealing with the variability due to proprietary differences in commercial imaging equipment. For our clients, we apply different strategies – from helping to select the sites with the same brand and model of imaging equipment or by designing an imaging protocol which allows for the standardization across the vendors and models.
We put a lot of emphasis on efficient data sharing between all stakeholders in the trial data by placing our cloud-based platform right in the centre of any project we take on. Dynamika Enterprise is a comprehensive cloud-based Clinical Trial Image Management System with an integrated multi-stakeholder data management, data upload and data read optimized workflows and a full suite of advanced image analysis functionality for semi and fully automated processing of the MRI sequences, perfusion CT, Xray and other imaging modalities.
In our experience the maximum benefit of sharing data is gained when the imaging collected is done in a high quality and uniform way. That means it is critical that imaging experts be involved in the design of the clinical trial which utilizes imaging as an endpoint in order to assure that the most appropriate imaging is used. Most clinical trials require considerable time to complete and using shared data would likely increase the longitudinal value of the data. That means that using the most reliable and accurate image techniques feasible will make the database relevant into the future.
Standardization of Imaging Protocols
There are several issues which can arise when using advanced imaging as an endpoint. As an example, use of dynamic contrast-enhanced MRI, the most popular modality for measuring perfusion in oncology studies and inflammatory activity in musculoskeletal studies will result in large variations in the appearance of images between brand of scanner and software levels as well as the high level of noise due to patient movement. Dynamic MRI however would allow shortening the trial length by almost half as well as reducing the number of patients needed to confirm statistical significant treatment impact. Image Analysis team has extensive experience in dealing with complex advanced imaging modalities. We advise our clients on the trial design, help selecting the right imaging sites and if needed conducting a small feasibility study in our reference centres to ensure that the selected imaging protocols are patient friendly and feasible in a standard patient care settings.
De-identification of Data and Patient Information
Dynamika Enterprise supports fully automated meta-data (DICOM header) based de-identification of the imaging data prior to any image being uploaded on a cloud and send to the centralized storage. Having practical experience with different imaging modalities helps us to advise our clients on how to ensure safety and anonymity of patient information.
It is important to document the collection of data and keep fully automated audit trail to make sure that the data is verifiable at any given time. The DICOM (DICOM Standards Committee) (Digital Image Communications in Medicine) standard facilitates this by embedding unique identifiers into each image. Dynamika Enterprise has added security mechanisms for secure transport and audit trails.
Standardized Image Review and Assessment
Because the changes in imaging studies are often subtle, and because consistency in decisions about changes in tumor status or degenerative changes are critical to the interpretation of trial results, having standardized image assessment is paramount. The images are interpreted by experienced reviewers who are utilizing fully integrated imaging reading flow methodologies and advanced techniques for semi or fully automated assessment of the images. Our readers achieve reproducibility of 95% and the fully automated routines (for cartilage volume or hippocampus volume or texture measurements) yield results with 100% reproducibility
What Our Clients Say
- I feel strongly that by making Dynamika available, student researchers could come up with very interesting and meaningful quantitative projects. Laura, Radiographer
- We have been using Dynamika software to analyse DCE data as part of a research project using multiparametric MRI for targeted radiotherapy treatment planning. We have found the software extremely useful compared with software delivered with our MRI scanner for a number of reasons, in particular: the ability to control each stage of the data processing, the ability to assess image quality and examine the parametric and pharmacokinetic maps in detail. Our project requires a quantitative (rather than qualitative) analysis of the DCE data and we have been very impressed with the collaborative approach of the Image Analysis support team in helping us achieve our goals. In addition, we commend the support team in providing informative and responsive training sessions and willingness to develop the software to meet the needs of our research project. Hayley Reynolds, Research Fellow, The Peter MacCullum Cancer Centre, Melbourne, Australia
- Dynamika is really fantastic! Salvatore Costantino, Post Doctoral Researcher, University of Sassari, Italy
I am a clinical-research fellow with high experience in prostate MRI analysis and reporting. I have been using Dynamika mostly to help the analysis support team to develop a PI-RADS structured reporting user interface.
The software is extremely useful and has the potential to be used in daily clinical practice. One of the most important skills of Dynamika is the capability of providing high quality tools to report prostate mpMRIs together with the possibility of assessing quantitative analysis at the same time.
Therefore, Dynamika opens a new window in the use of automated and semi-automated algorithms both for clinical and research purposes.
The integration of these two aspects is further strengthened by the remarkable competence of the support team that is constantly willing to help me when necessary.
I hope to keep on working with Dynamika and taking advantage of all its valuable tools during my clinical-research practice.
Francesco Giganti- Clinical Research Fellow, University College Hospital, London, UK
- Dynamika is key to precise and accurate early diagnostics and a powerful tool for follow-up of post-op and post chemo and/or radio treatment patients. Roman Marin, Head of CT and MRI Department