FDA approves PET tracer trial testing ability to diagnose multiple sclerosis

The Food and Drug Administration has given the go-ahead for the first in-human testing of a novel imaging tracer that may change the way clinicians diagnose multiple sclerosis.

Case Western Reserve University researchers developed the PET agent to bind to the protective coating surrounding nerves, known as myelin. The imaging tracer—dubbed Myeliviz—lets physicians visualize this protective sheath, which is critical to assessing the damage caused by multiple sclerosis.

“Myelin has never been directly imaged before,” co-inventor of the agent, Yanming Wang, PhD, with the Cleveland, Ohio-based institutions’ school of medicine, said in a news release. “Our technique is the first to do so, and we are hopeful that this will provide earlier and more accurate diagnosis of MS.”

According to the National Multiple Sclerosis Society, more than 2.3 million people across the globe are impacted by MS. The autoimmune disease can be incredibly hard to identify, especially during early stages when symptoms are varied and unpredictable. Limitations in imaging technologies have also held back progress in this area, the researchers noted.

Myeliviz is administered via an IV prior to a PET scan. Clinicians can view damage to myelin through dark spots on corresponding images, offering new evidence for clinicians to aid in their diagnosis.

“Myeliviz could be the missing link in finding a cure for MS and other myelin diseases by serving as a specific and quantitative imaging marker for early diagnosis and sensitive, quantitative evaluation of novel therapies currently under development,” said co-inventor Chunying Wu, PhD, a radiology instructor with Case Western.

The team believes their approach may be used as an aid, and in some situations as a replacement, to MRI. The latter is considered the current standard-of-care for imaging MS, but is not effective for monitoring the disease.

The human clinical trials will be conducted at the Cleveland Clinical Mellen Center for Multiple Sclerosis thanks to a $1.7 million grant from the National Institutes of Health.