Central Nervous System (CNS), Ophthalmology
Imaging modalities, such as CT, MRI and PET, are beneficial for diagnosis and evaluating therapeutic effect for Alzheimer’s disease, brain tumors and other central nervous diseases. Since the establishment of our company, Micron has been engaged in the area of CNS, and has built extensive expertise of handling the whole process from image acquisition to analysis and assessment.
In ophthalmology, many drugs and medical devices have recently been developed in areas such as age-related macular degeneration. Micron is also experienced in handling OCT, fundus fluorescein angiography (FA/IA), and fundus auto fluorescence (FAF) images studies.
Achievements
| Target Disease | Modality |
|---|---|
| Alzheimer’s disease (AD) | MRI、PET |
| Brain tumor | MRI、PET |
| Antidepressant | PET、MRI |
| Cerebral infarction | MRI |
| Macular edema | OCT |
| Age-related macular degeneration | OCT、Fundus fluorescein angiography（FA/IA) |
| Fundus oculi | Fundus camera |
| Iris pigmentation | Others |
Alzheimer’s Disease
Assessing MRI and PET imaging by central reading is essential for confirming subject eligibility and for evaluating safety and efficacy of the study drug. Micron will establish an Alzheimer’s disease study expert team, such as radiologists who have expertise in AD diagnosis, radiological technologists who specialize in MRI and PET imaging, and a project manager who is well-versed in clinical development and monitoring. This team will provide support throughout the clinical trial; site qualification, imaging condition coordination, phantom tests (for imaging standardization), central review and image analysis. We also have proficiencies in advanced types of image data analysis including brain volume measurement. Our self-developed remote reading system can be customized flexibly to meet the requirement of the study, and offer high-quality and efficient central review results rapidly.
Cerebral Infarction
Along with the growth of regenerative medicine techniques, the therapeutic drug development of cerebral infraction is accelerating. In this area, utilizing MRI, PET, and CT for quantitative and qualitative assessment is beneficial for evaluating therapeutic responses. However, in many of these studies, the image acquisition and analysis method are different from the routine medical care which is a challenge in clinical trials.
In such studies, it will be crucial to select medical institutions which can conduct the specific imaging acquisition. Micron will support the study site selection to confirm the scanners and their settings to make sure whether the site will be able to conduct the designated scanning procedure.
Micron’s academic network enables to us find the appropriate reader for the clinical trial, and arrange the central review meetings that suits the protocol. If the study needs a type of advanced analysis, such as infarct volume measurements, our well-experienced, specialized staff will conduct pre-analysis, and support central review meetings to rapidly provide high-quality analysis data to the sponsor.
Measuring Retinal Thickness by OCT
The measurements of retinal thickness by Optical Coherence Tomography (OCT) is commonly used to evaluate treatment responses such as age-related macular degeneration, diabetic retinopathy, glaucoma, detached retinas, macular edema, macular holes, and the epiretinal membrane. However, unlike CT and MRI, which outputs the image data in a standardized format, DICOM, the output format varies depending on the OCT manufacturer and manufacturer-specific data analysis software is needed. Micron already owns multiple software programs for the image data from various OCT devices, and is well prepared to operate central review and image analysis for Ophthalmology studies.