Hyperpolarized Carbon Imaging for Multiple Sclerosis

(MIIMS Trial)

This trial tests a new imaging method to predict how well individuals with relapsing-remitting multiple sclerosis (MS) respond to a specific treatment. The goal is to use hyperpolarized carbon imaging, a special MRI technique, to monitor brain inflammation and therapy effects. This technology could simplify tracking the disease's progress without invasive procedures. Individuals who haven't received MS treatments in the past two years and are starting anti-CD20 therapy might be suitable candidates. The imaging involves using an HP 13C pyruvate injection. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

The trial requires that you have not taken disease-modifying therapies (DMTs) for at least two years and that you have not started anti-CD20 therapy yet, but you must stay on anti-CD20 therapy during the study. If you are taking corticosteroids, you must stop them at least 30 days before screening.

Research has shown that hyperpolarized carbon imaging with HP 13C pyruvate injections is generally safe. Over 860 people have received this injection without serious side effects. The safety data support using HP 13C pyruvate, a stable form of carbon. Although primarily studied for cancer imaging, its safety record is promising for new applications, such as in multiple sclerosis (MS). To date, no major problems or negative reactions have been reported, indicating that the treatment is well-tolerated in humans.¹²³⁴⁵

Researchers are excited about hyperpolarized carbon imaging for multiple sclerosis (MS) because it offers a unique way to visualize metabolic changes in the brain, which could enhance diagnosis and monitoring of the disease. Unlike standard MRI scans, which primarily show structural changes, this method uses HP 13C pyruvate to provide real-time insights into cellular metabolism, potentially revealing disease activity before significant damage occurs. This innovative approach could lead to earlier and more precise intervention strategies, making it a game-changer in the management of MS.

This trial will use a special type of MRI scan, called hyperpolarized 13C MR metabolic imaging, to detect increased lactate production linked to immune cell activity in the brain. Participants will receive an HP 13C pyruvate injection to facilitate this imaging. Previous studies have successfully used this method to monitor the effectiveness of multiple sclerosis (MS) treatments, such as fingolimod and dimethyl fumarate, by highlighting changes in energy use in MS-affected areas. Research indicates that this imaging method can provide valuable insights into the disease's state and progression over time. This approach has proven safe and effective in other areas, such as cancer imaging, and its use for MS may help predict patient responses to certain therapies.¹⁴⁵⁶⁷