New Technology Could Allow MS Patients to Avoid Gadolinium-Based MRI Scans

Published on March 19, 2019 by Sandy Liebhard

The growing availability of new technology could allow doctors to monitor disease progression in Multiple Sclerosis (MS) patients without using  gadolinium-based MRI contrast agents.

New Tech Improved Images on Gadolinium-Free MRIs

People with relapsing MS generally undergo MRI brain scans with gadolinium-based agents every six months to two years. But enhanced MRIs take longer and cost more, while repeated exposure to the toxic metal may increase the likelihood that a patient will retain gadolinium in their brain, tissue, and other organs.

Advances in non-contrast MRI image acquisition and post-processing technology, along with the increasing availability of powerful 3T MRI machines, recently raised the possibility that gadolinium-free MRIs could have a role in MS follow-up imaging.

To test this thesis, scientists at the Technische Universität München in Germany used a 3T MRI scanner to assess new or enlarged brain lesions in 359 MS patients.  Both 3D MRI and subtraction maps were used to significantly improve the visualization achieved on the unenhanced scans.

Out of 507 follow-up images, 264 showed evidence of disease progression. A total of 1,992 new or enlarged lesions were also detected. According to the study authors, the gadolinium-free MRIs identified all cases of MS progression and missed just four of the lesions.

“Several vendors have made tools for generating subtraction images commercially available,” senior author Benedikt Wiestler, M.D., said in a statement announcing the study’s findings. “Implementing such tools into the routine clinical work flow will help to make the use of contrast agent dispensable in routine follow-up imaging of MS patients.”

FDA Warnings for Gadolinium-Based MRI Agents

The U.S. Food & Drug Administration (FDA) has approved eight gadolinium-based MRI agents for use in the United States:

• Dotarem
• Eovist
• Gadavist
• Magnevist
• MultiHance
• Ominiscan
• Optimark
• Prohance

In 2007, the agency warned that gadolinium-contrast dyes could cause debilitating disease called nephrogenic systemic fibrosis in people with pre-existing kidney disease. The agents have been contraindicated for this patient population ever since.

The FDA issued a new warning in December 2018, after several studies found that gadolinium could be retained in the body for months or years after an MRI, even in patients with normal kidney function.

Among other things, the agency noted that linear agents (Eovist, Magnevist, MultiHance, Ominiscan, and OptiMark) appeared to be associated with higher rates of gadolinium retention compared to their macrocylic counterparts (Dotarem, Gadavist, and Prohance). Doctors were subsequently advised to consider retention characteristics when choosing an MRI contrast dye for patients who may be at higher risk, including:

• Those requiring multiple lifetime doses
• Pregnant women
• Children
• Patients with inflammatory condition

Gadolinium Deposition Disease Lawsuits

While the FDA has received reports of adverse events involving multiple organ systems in patients with normal renal function, it has yet to conclude that gadolinium retention caused any of the reported complications.

Nevertheless, a growing number of plaintiffs claim gadolinium-based MRIs did harm patients with healthy kidneys. According to their lawsuits, these individuals allegedly suffer from Gadolinium Deposition Disease, a debilitating disorder characterized by one or more of the following symptoms:

• Intense burning of the skin and skin substrate
• Intense boring pain in bones or joints
• Brain fog or mental confusion
• Muscle vibrations, pins and needles sensation
• Headache
• Thickening, discoloration, pain in the skin or skin substrate of the distal arms and legs.

Plaintiffs further assert that the drugs’ manufacturers were aware for years that gadolinium deposits could remain in the body long after an MRI, but failed to warn doctors and patients about the risks potentially associated with their products.