About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Treatment with corticosteroids within 30 days prior to screening.
Patients unwilling or unable to undergo MR imaging, including patients with contra-indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.
Poorly controlled hypertension, defined as either systolic >160 or diastolic >110. The addition of anti-hypertensives to control blood pressure is allowed for eligibility determination.
Congestive Heart Failure ≥ NYHA Class II.
Trial design
Treatments tested in this trial
- HP 13C pyruvate injection
- MRI Scanner
Treatment groups
Sponsors and collaborators
Ari Green
Lead sponsor
University of California, San Francisco
Sponsor institution
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator