MRI endpoints now play a key role in the overall design of Neuroscience clinical trials. Bioclinica has experience with all of the most commonly used MRI sequences in today's trials.
|High Resolution 3DT1||6-8 min||Volumetric assessments such as quantification of brain, hippocampal and ventricular volume changes (atrophy) over time.|
|FLAIR||3-5 min||Qualitative and quantitative assessment of white matter abnormalities. This sequence is more convenient than T2 for subcortical abnormalities and for automatic segmentation of brain lesions (due to suppression of the CSF signal intensity).|
|T2||2-5 min||Assessment of white matter abnormalities. It is known to be more sensitive than FLAIR in the posterior fossa.|
|T2*||2-5 min||Detection of microbleeds and other brain hemorrhages.|
|Diffusion-Weighted Imaging (DWI)||1-2 min||Safety assessments in order to detect ischemic changes and for the evaluation of the brain’s diffuse microstructural damage.|
|Diffusion Tensor Imaging (DTI)||2-5 min||Evaluation of brain’s diffuse microstructural damage and fractional Anisotropy.|
|Perfusion-Weighted Imaging (PWI)||80s||Quantitative or semi-quantitative perfusion parameters. The acquisition requires the injection of a gadolinium-based contrast agent.|
We have experience with all trial phases and can provide support from the start of a trial (protocol design and imaging charter development) all the way through to regulatory submission and archiving of image data with a full 21 CFR Part 11 compliant process. We have extensive experience applying neuroimaging for Eligibility (inclusion or exclusion of study patients), Efficacy (primary and secondary endpoints), and Safety (evaluating safety profiles) components of clinical trials.
MRI based criteria for eligibility, safety and efficacy endpoints
|Alzheimer's Disease||Acute Stroke||Multiple Sclerosis|