Image Data Management and Analysis in Alzheimer’s Disease Trials
Medpace Imaging Core Lab (MICL) provides a comprehensive medical image management and analysis services portfolio for Alzheimer’s Disease (AD) trials. The key services and technologies include:
Site Qualification & Training (MRI & PET), Ongoing Quality Assurance
Sites are provided with manufacturer (vendor) and model-specific image acquisition parameters to minimize inter-site variability. Phantom scans are used during the site qualification phase as well as during the course of the study.
MRI & PET Data Collection & QC
The image data will be transferred to MICL by the sites using a dedicated web-based image data upload portal. The image data will be electronically uploaded after de-identification and encryption. A study-specific electronic Data Transmittal Form (DTF) will be filled out by the sites during the image submission process. The electronic upload of MRI & PET scans represents a significant gain in terms of time and quality.
MRI & PET scans will be quality controlled upon receipt at MICL. In case of insufficient image quality or significant deviations with regard to the study’s imaging protocol, repeat scans may be requested by MICL whenever possible.
Management of Central Eligibility & Safety Evaluations
MICL performs eligibility and potentially safety evaluations on an ongoing basis and within short turnaround times (usually one to three days). Each scan will be centrally evaluated by a board-certified neuroradiologist. Key eligibility/safety parameters will include:
Evidence of vasogenic edema (ARIA-E)
Number and localization of cerebral microhemorrhages (ARIA-H)
Number and localization of lacunar infarcts
Evidence of superficial siderosis
Significant white matter abnormalities
Other abnormalities, etc.
In case of significant safety findings after enrollment, MRI scans may be repeated at regular intervals until resolution of the corresponding findings. Safety findings will be systematically escalated to Medpace’s clinical team, the Sponsor’s clinical monitors and the site. Such escalations will be expedited by MICL. Whenever needed, the image data and related imaging eCRFs can be accessed online during conference calls for final decision-making.
Development of the Image Evaluation System
MICL will develop and validate a web-based and cloud-based Image Evaluation System for central evaluations including study-specific imaging CRFs. The Image Management and Evaluation System will include built-in logical checks to avoid data inconsistencies and omissions.
Furthermore, the imaging data and associated eCRFs will be made available online in a read-only mode for clinical monitoring (Sponsor, CRO) and audit/inspection purposes.
Selection and Training of Central Readers
A pool of highly qualified and experienced neuroradiologists will be involved in central reading operations. MICL will suggest names of potential readers, provide CVs, and the sponsor will review and approve. The sponsor may also suggest other readers.
MICL will develop an Image Evaluation Manual for central readers. The readers will be trained by MICL prior to the beginning of central evaluations:
Review of key definitions and consensus points
Presentation of the Image Evaluation System and related eCRFs
Evaluation of test cases (non-study patients)
Review of the overall reading process, deliverables and expectations
Image Processing and Quantification Services
After completion of image data QC, MRI & PET scans will be processed for quantitative data analysis. The analyses will be focused on extracting quantitative parameters from structural MRI and PET (FDG, amyloid imaging) scans. The image processing and quantification services may include the following processing steps:
MRI signal intensity inhomogeneity correction
3D registration for longitudinal follow-up of volumetric data
Quantification of intracranial cavity volume
Ventricular volume and ventricular enlargement quantification
Total brain volume and brain atrophy quantification
Total hippocampal volume and hippocampal atrophy quantification
Cortical volume and atrophy quantification
Quantification of white matter abnormalities
Analysis of diffusion (DWI) and diffusion tensor imaging (DTI) data