Calyx 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. Calyx 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). Apart from standard MS assessments such as lesion counts (including lesion evolution), lesion and brain volumes Calyx also supports advanced MS analyses:
FUNCTIONAL MAGNETIC RESONANCE IMAGING (FMRI)
fMRI can be used to measure brain activity at rest or while performing a task by detecting the changes associated with blood flow. The underlying understanding is that cerebral blood flow and brain activity are directly correlated. Similarly, functional brain connectivity can be deduced using fMRI data. Activation and/or functional connectivity maps and analysis can provide insight into the brain activity and hence possible abnormalities and response to therapeutics.
DOUBLE INVERSION RECOVERY (DIR)
The Double Inversion Recovery sequence (DIR) has been advocated for detecting gray matter (GM) lesions due to its ability to enhance soft tissue contrast in the brain. It combines two inversion pulses in order to simultaneously suppress signals from tissues with different longitudinal relaxation times. In the brain, DIR allows to selectively image grey matter (GM) by nulling the signal from white matter (WM) and cerebrospinal fluid (CSF) at the time of the excitation pulse.
OPHTHALMIC IMAGING
Within Multiple Sclerosis, it is possible to see structural changes in the retina, specifically within the Ganglion Cell Arteritis (GCA) and Nerve Fiber Layer (NFL). A combination of OCT, FP, and FAF could be appropriate for your trial to evaluate the retinal changes. The combination of Calyx’s operational bench strength and global site/image processing capabilities with
the expertise of Calyx’s medical advisor make for an ideal study management structure.
Ophthalmology imaging endpoints have historically been serviced by academic core labs and though they offer the relevant expertise in the modality and indication, they lack the infrastructure, validated quality systems and SOPs to manage a late phase study. Leveraging expertise across each lab, including Calyx’s systems and export capability will reduce the added workarounds by the sponsor.
Case Study
Calyx Medical Imaging played a vital role in a phase 2, double blind, randomized, multicenter trial in patients with relapsing-remitting multiple sclerosis including MTI analysis. During site standardization Calyx supported the installation of the MTI specific software on the MRI scanners. 110 timepoint MTI datasets of 12 patients have been acquired, collected and processed. Structural MR image processing encompassed image pre-processing, linear spatial normalization, and voxel classification. Lesion-based mean Magnetization Transfer Ratios (MTR) and voxel-based gray matter and white matter MTR histograms were derived for the MTR analysis.
Experience
Calyx Medical Imaging’s experience is drawn from managing over 2600 trials to date which include more than 4.4 million images from roughly 155,000 sites globally. Within this experience is our management of nearly 180 CNS protocols and over 30 MS studies, of which 4 included advanced MRI.
Calyx experience in implementing advanced MRI techniques in Multiple Sclerosis studies:
