Mango Imaging - Medical Image Analysis
All pharmaceutical companies apply medical imaging to the drug development process. One key difference between the application of medical imaging for drug development versus clinical diagnosis is quantification. The biomarkers obtained from medical imaging must be quantifiable in order to compare groups (for example, based on treatment or disease) in clinical trials at every stage in the drug development process. Another important difference is the fact that drug treatments may only produce subtle effects in the biological system under investigation. It is crucial to have a robust and thorough data analysis pipeline in order to maximize any potential effect size. This requirement is equally applicable for pre-clinical and clinical experiments.
The cost of each stage in the drug development process necessitates careful consideration when selecting the right set of biomarkers for both safety and efficacy. Positron Emission Tomography (PET) studies may be used to investigate drug occupancy since the PET signal is sensitive to the concentration and affinity of competing unlabelled exogenous drugs, and changes in the binding potential of the injected radioligand give a direct measure of competing drug occupancy. The ability to accurately measure drug occupancy provides a powerful technique to determine an efficacious dose while minimizing potential side effects and adverse events, and may lower the attrition rate in drug development. Magnetic Resonance Imaging (MRI) studies are commonly used to assess safety endpoints in clinical studies involving neurological or psychiatric diseases. Given the initial cost involved in the acquisition of MRI data, structural or functional measurements may be performed in addition to the safety endpoints in order to provide preliminary efficacy endpoints at an earlier stage in the drug development process. This efficient use of imaging biomarkers, both for safety and efficacy, provides important information to the internal decision-making process before proof-of-concept or commit-to-development has been determined.
Mango Imaging provides fully quantitative image analysis and statistical inference services for MRI and PET studies. Data analysis pipelines have been established for a variety of experiments in each modality, along with step-by-step quality assurance and quality control checks. Examples of image analysis services currently available are
- SUV calculations for FDG-PET, and other radiotracers
- Kinetic modelling for CNS radiotracers
- Functional MRI quantification
- Diffusion-weighted imaging quantification (DTI, HARDI, ADC)
- Dynamic contrast-enhanced MRI quantification
Additional imaging experiments are also supported and we welcome the opportunity to discuss alternative imaging biomarkers. Mango Imaging is also able to provide advice in protocol development and work with the data acquisition provider(s) in order to achieve high-quality results.
All methodology is based on published research, and may be combined in a modular fashion to provide fully customized and fit-for-purpose data analysis pipelines. The in-house image data management system (IDMS) at Mango adheres to industry standards and results are managed by an in-house reporting system. End-to-end audit trails and a robust system of documentation ensure a transparent set of procedures is applied to each study.
Please contact us via imaging@mango-solutions.com for more information on how we can help analyze your medical imaging data.