Hyperpolarized Carbon Metabolic Imaging in Multiple Sclerosis
Assessing Metabolic Changes in Multiple Sclerosis Using Hyper-polarized Carbon 13 MRI
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: MRI scans, Blood draws, Injections
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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 is a prospective investigational study to evaluate the utility of HP 13C pyruvate MRI for assessing metabolism in MS lesions and monitoring response to treatment."
- "These participants will undergo two more HP 13C pyruvate MRI scans and one standard MRI over the span of approximately one year."
- "Participants will have blood draws for blood-based biomarkers of disease activity and will undergo standard MS clinical assessments."
- "Presently, MRI is used to assess active/inactive CNS lesions."
- "Over 1,000 patients have been safely scanned with HP 13C pyruvate injection before March 2026."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether a special MRI scan called hyperpolarized carbon imaging can predict how people with multiple sclerosis (MS) respond to anti-CD20 treatment. It is for adults with relapsing-remitting MS, where symptoms come and go, who plan to start this treatment. The study includes MRI scans, health checks, and blood tests.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 18 or older.
- You have relapsing-remitting MS and have not used disease-modifying treatment (medicine to slow MS) for at least two years.
- You have never had anti-CD20 treatment. Your doctor plans to start it, and you must stay on this type of treatment throughout the study.
- Screening must show at least one MS lesion (area of damage) measuring 10 mm across in one direction.
- If you could become pregnant, you must agree to a urine pregnancy test before study scans.
Who can't join
- You took corticosteroids (steroid medicines) within 30 days before screening.
- You cannot or will not have an MRI, including because of an unsafe pacemaker or clips in brain blood vessels. Braces or fixed metal in your jaw or face also rule you out.
- Your blood pressure is above 160 for the top number or 110 for the bottom number. Medicine to control it is allowed. You have heart failure rated NYHA class II or higher, important abnormal heart electrical tests, a family history of long QT syndrome (a heart rhythm problem), or a heart attack in the past six months.
- You are pregnant or breastfeeding/chestfeeding. Breastfeeding/chestfeeding must stop before you receive the study imaging substance.
- You have a known allergy to HP 13C pyruvate (the study imaging substance) or its ingredients, or a past allergy to gadolinium MRI contrast dye.
- You had cancer within the past five years or chemotherapy within the past two years.
- You have a history of kidney disease or a kidney filtering test result (GFR) below 60. Your starting EDSS score, which measures MS-related disability, is above 6.5.
- You have another major illness that the study doctor thinks could affect your safety or the results, or a health or social situation that could keep you from following study steps.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Subjects must be 18 years or older. 2. Relapsing remitting MS, naïve to DMTs for the past two years minimum 3. 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. 4. Patients enrolled will be screened for at least one MS lesion with a 10mm diameter in one plane. Exclusion criteria: 1. Treatment with corticosteroids within 30 days prior to screening. 2. 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. 3. 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. 4. Congestive Heart Failure ≥ NYHA Class II. 5. History of clinically significant EKG abnormalities, including QT prolongation or a family history of prolonged QT syndrome. 6. Myocardial infarction within 6 months of study entry. 7. Individuals who are pregnant. Individuals of childbearing potential (defined below) must agree to undergo a urine pregnancy test prior to participating in the study scans. Pregnant individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn child secondary to administration of HP 13C pyruvate to the study participant. A female is considered to not be of childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and/or bilateral oophorectomy for removal of uterus and/or ovaries). 8. Individuals who are breastfeeding/chestfeeding. Breastfeeding/chestfeeding individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn/nursing child secondary to administration of HP 13C pyruvate to the study participant. Breastfeeding/chestfeeding should be discontinued before administration of HP 13C pyruvate. 9. Known hypersensitivity to HP 13C pyruvate or any of its excipients. 10. History of cancer within five years of enrollment date and/or history of chemotherapy within two years of enrollment date. 11. Any dental braces or permanent or undetachable metals in the jaw or face. 12. Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic, urologic, endocrinologic, neurologic, pulmonary, psychiatric, dermatologic, allergic, renal, or other major diseases that in the PI's judgment may affect the interpretation of study results or patient safety. 13. Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study procedures. 14. Glomerular filtration rate (GFR) of less than 60 mL/min/1.73 m² on baseline visit or subsequent study visits, history of kidney disease or history of hypersensitivity to gadolinium contrast agent. 15. Baseline EDSS \>6.5
Study sites (1)
CA
- Byers Hall · San Francisco, CA 94158Harkee S Halait, BS · Study contact · 415-745-1304 · harkeerat.halait@ucsf.eduAngelica Montevirgen, BS · Study contact · angelica.montevirgen@ucsf.eduAri J Green, MD, MCR · Principal investigatorJeremy Gordon, PhD · Sub-investigatorMore trials in San Francisco