Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

Hyperpolarized carbon imaging to see if MS patients respond to anti-CD20 therapy

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

Run by University of California, San Francisco · NCT07510607 · Data updated 2026-11-12

This study tests whether hyperpolarized carbon MRI can predict which relapsing remitting MS patients will respond to anti-CD20 therapy.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment40 (estimated)
SponsorUniversity of California, San Francisco
Academic / other
Drugs / interventionschemotherapy
Locations1 site (San Francisco, California)
StatusRecruiting
StartedJune 3, 2026
Main results expectedDecember 1, 2029
Study endsDecember 1, 2029
Registry record updatedJune 8, 2026
Trial IDNCT07510607 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) with relapsing-remitting MS who have not used DMTs in the past two years and are starting anti-CD20 therapy as part of standard care.

Probably not a fit

Patients who do not show a detectable metabolic signal change or who do not respond to anti-CD20 therapy may not experience a measurable benefit from this imaging approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 prospective study evaluating HP 13C pyruvate MRI as a tool to assess brain metabolism and monitor response to anti-CD20 therapy in RRMS patients who have not previously used DMTs. An initial optimization cohort of 8 patients will refine imaging parameters, followed by 32 RRMS participants who will have baseline, two follow-up HP 13C MRI scans and one conventional MRI over about a year, plus blood biomarkers and standard clinical assessments. The aim is to determine if metabolic signals from HP carbon imaging correlate with treatment response and disease activity. Imaging leverages the Warburg effect to visualize inflammatory metabolism in MS lesions, potentially providing a non-ionizing biomarker for personalized treatment decisions.

Why it matters

Potential benefit: If successful, this imaging approach could help predict which patients will respond to anti-CD20 therapy and guide treatment decisions.

How similar studies have gone: Prior oncology use of HP carbon imaging supports feasibility, and this study extends the approach to neuroinflammation in MS, which is exploratory but builds on existing promising methods.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Byers Hall
    San Francisco, California, United States
    Recruiting

Study contacts

  • Principal investigator: Ari Green, MD — University of California, San Francisco

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.