Perceptive Medical Imaging is a leading imaging core lab with the experience and ability to provide a wide range of services involving neuroimaging in clinical trials. Perceptive Medical Imaging’s CNS group understands the unique and custom requirements required of Multiple Sclerosis trials and have the flexibility, creativity, bandwidth, and understanding already in place to effectively manage and support these clinical trials.
A significant portion of our CNS experience is in Multiple Sclerosis (MS). For MS studies, we recommend conventional MRI sequences (T1, T1 post gadolinium, FLAIR and T2) for MS lesion evaluation (lesion counts and lesion volume). From the T1 sequence brain volume assessments such as total brain volume/brain volume change, grey matter volume, white matter volume, and CSF (cerebrospinal fluid) volume can be derived. Perceptive can support further exploratory measures analyzed on Magnetization Transfer Imaging, Diffusion Tensor Imaging and Double Inversion Recovery. As a basis of a robust independent review assessment, standardized image acquisition is key. Thus, site training and imaging acquisition guidelines are critical for consistent and high-quality MRI images.
Case Study
Perceptive Medical Imaging played a vital role in a phase 3, double blind, randomized, multicenter trial in patients with relapsing-remitting multiple sclerosis. Based on the centrally assessed imaging data it was shown that the investigational drug significantly reduces MS lesion activity. The superiority of the investigational drug against interferon treatment was also demonstrated on clinical grounds (relapse rate reduction of 52%). The trial was the largest phase 3 clinical trial program ever submitted to the FDA for a new MS drug at the time.
