Multiple Sclerosis (MS) Clinical Trials

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Assessing Metabolic Changes in Multiple Sclerosis Using Hyper-polarized Carbon 13 MRI

Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The main purpose of this study is to assess whether hyperpolarized carbon imaging in relapsing remitting multiple sclerosis (MS) patients can be used to predict response to anti-CD20 disease modifying therapy. Study procedures will include magnetic resonance imaging (MRI) assessments with a hyperpolarized pyruvate sequence, clinical assessment as well as blood markers of disease progression. This method of imaging utilizes the Warburg effect, where innate immune cells utilize a metabolic shift to glycolysis instead of oxidative phosphorylation. In pre-clinical data, increased hyperpolarized lactate production has been found to be associated with increased microglial/macrophage infiltration in the brain. Although hyperpolarized carbon imaging in humans has been established and used in the field of oncology, this will be one of the first applications of hyperpolarized carbon the study of neuroinflammation in humans. We predict that hyperpolarized carbon imaging may have the potential to monitor and evaluate neuroinflammation in MS, and in particular the innate immune activation state that plays a role in MS progression. This imaging method may provide non-invasive monitoring of disease progression and therapy response for MS patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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⁃ In order to be eligible to participate in this study, an individual must meet all of the following criteria:

• Subjects must be 18 years or older.

• Relapsing remitting MS, naïve to DMTs for the past two years minimum

• Patients must be naive to anti-CD20 therapy with plans to begin the therapy as part of their physician's multiple sclerosis treatment plan. The patients must remain on a form of anti-CD20 therapy for the entirety of their enrollment in the study.

• Patients enrolled will be screened for at least one MS lesion with a 10mm diameter in one plane.

Locations
United States
California
Byers Hall
RECRUITING
San Francisco
Time Frame
Start Date: 2026-06-03
Estimated Completion Date: 2029-12-01
Participants
Target number of participants: 40
Treatments
Other: HP13C MRI
8 patients will be imaged once to optimize HP 13C MR parameters for improved spatial and temporal resolution. This group will receive HP 13C pyruvate injection at a dosage of 0.43 mL/kg body weight. 32 RRMS patients who will undergo anatomic and HP 13C pyruvate MRI scans at timepoints of baseline, 1.5 months, 3 months, 12 months. This group will receive HP 13C pyruvate injection at a dosage of 0.43 mL/kg body weight.
Related Therapeutic Areas
Sponsors
Leads: Ari Green
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov