Clinical Trial Services
The Buffalo Neuroimaging Analysis Center (BNAC) is a dedicated research center that has extensive expertise in multiple sclerosis (MS) clinical trials. At BNAC, we support several key areas of ongoing research related to furthering the understanding of MS. These include qualitative and quantitative magnetic resonance imaging (MRI) evaluations of lesion activity and accumulation in the brain, spinal cord, and optic nerve, development of atrophy, microstructural changes, brain connectomics, optical coherence tomography (OCT), and molecular imaging via the use of novel radiotracers via positron emission tomography (PET) imaging. Through these areas of research, we are committed to supporting regulatory approvals of medications and other interventions that use imaging outcomes in their trial design.
Lesion Related Outcomes
Lesion activity is a key outcome in MS clinical trials, and BNAC is a world leader in the quantitative evaluation of lesion-related endpoints in patients with MS. BNAC uses a three-level quality control system where scans are reviewed by multiple expert evaluators and the resulting gold-standard regions of interest (ROIs) are painstakingly edited to ensure the highest possible accuracy. In addition, BNAC has also been working to augment expert raters with deep learning systems in clinical trial workflows to improve overall quality of lesion detection. The high quality of BNACs three-level quality control system provides unparalleled training data for us to teach artificial intelligence (AI) systems to identify and delineate brain regions and areas of pathology. By feeding this back into clinical trial activities, we are able to augment human operators to further improve precision of lesion delineation and accuracy of lesion detection and maximize study power.
Central Nervous System Atrophy
Brain atrophy has become an important endpoint in all recent major MS trials, providing a window into the impact of therapies on neurodegenerative processes. BNAC has extensive expertise in the development and application of quantitative algorithms for brain volumetry and change detection, and has contributed numerous techniques to improve the accuracy and power of clinical investigations and therapeutic trials. Additionally, BNAC has contributed new measurement methods for real-world clinical use, such as the NeuroSTREAM platform.
BNAC is using a variety of imaging measures to evaluate microstructural damage in the central nervous system (CNS). Among others, these include magnetization transfer and diffusion tensor imaging for in-vivo insight into demyelination and remyelination, spectroscopy for exploration of metabolic changes, quantitative susceptibility mapping for measuring iron changes, and perfusion for detecting cerebral blood flow alterations.
Our brain connectomics work uses state-of-the art structural and functional MRI connectivity measurements to help better understand neuroplasticity, recovery, and cognition. These tools provide an important means to better understand the pathophysiological underpinnings of cognitive changes in MS, as well as to better understand the impact of therapies on cognition
Optical Coherence Tomography
Our optical coherence tomography (OCT) research has shed new light on neurodegenerative central nervous system processes by allowing direct imaging of the retinal nerve fiber layer – the only region of the CNS where neurodegeneration and demyelinating processes can be 100% separately assessed due to the non-myelinated nature of retinal nerve neurons.
Radiotracers and PET Imaging
Our novel work with radiotracers and positron emission tomography (PET) Imaging has expanded the understanding of molecular drivers in MS disease progression and pathology, including providing a means to independently evaluate the activation of microglia.
For more information about imaging endpoints, click here.
Featured Recent Clinical Trials in MS
- Zivadinov R, Dwyer MG, Carl E, Poole EM, Cavalier S, Briassouli P, Bergsland N. Slowing of brain atrophy with teriflunomide and delayed conversion to clinically definite MS. Ther Adv Neurol Dis 2020;13:1756286420970754. [Open article]
- Moore JJ, Massey JC, Ford CD, Khoo ML, Zaunders JJ, Hendrawan K, Barnett Y, Barnett MH, Kyle KA, Zivadinov R, Ma KC, Milliken ST, Sutton IJ and Ma DDF (2019). "Prospective phase II clinical trial of autologous haematopoietic stem cell transplant for treatment refractory multiple sclerosis." J Neurol Neurosurg Psychiatry 90(5): 514-521. [Open article]
- Zivadinov, R., et al., A Serial 10-Year Follow-Up Study of Atrophied Brain Lesion Volume and Disability Progression in Patients with Relapsing-Remitting MS. AJNR Am J Neuroradiol, 2019. 40(3): p. 446-452. [Open article]
CONTACT OUR TEAM TODAY
Part of BNAC’s mission is to help share our tools and experience with our colleagues and other industry partners. If you need help with managing a medical imaging trial related to Parkinson’s disease, please reach out to discuss how we can assist. Our group brings decades of experience and expertise to every collaborative study and service partnership.