Multiple SclerosisPhase 2MIIMSNCT07510607
Hyperpolarized Carbon Metabolic Imaging in Multiple Sclerosis
A Phase 2 study testing HP 13C pyruvate injection and MRI Scanner in people with Multiple Sclerosis and RRMS, run by Ari Green at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, RRMS, Relapsing Remitting MS
- What is being tested?
- HP 13C pyruvate injection and MRI Scanner
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2026to 1 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- History of clinically significant EKG abnormalities, including QT prolongation or a family history of prolonged QT syndrome.
- Myocardial infarction within 6 months of study entry.
Show all 17Show fewer
- 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).
- 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.
- Known hypersensitivity to HP 13C pyruvate or any of its excipients.
- History of cancer within five years of enrollment date and/or history of chemotherapy within two years of enrollment date.
- Any dental braces or permanent or undetachable metals in the jaw or face.
- 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.
- 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.
- 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.
- Baseline EDSS >6.5
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Byers Hall
San Francisco, California, 94158
Harkee S Halait, BS, 415-745-1304, harkeerat.halait@ucsf.edu
Angelica Montevirgen, BS, angelica.montevirgen@ucsf.edu
About this study
Official title: Assessing Metabolic Changes in Multiple Sclerosis Using Hyper-polarized Carbon 13 MRI
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.
Read the detailed description
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. A total of 40 relapse-remitting (RRMS) patients naïve to DMT and starting on an anti-CD20 therapy as part of their routine MS clinical care will be recruited. In a preliminary cohort, 8 patients will be imaged once to optimize HP 13C MR parameters for improved spatial and temporal resolution. Using these sequence parameters, we will then image 32 RRMS patients who will undergo a baseline anatomic and HP 13C pyruvate MRI scan prior to receiving 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.
Multiple Sclerosis (MS) is the most prevalent chronic inflammatory disease of the central nervous system (CNS) among adults, characterized by demyelinating lesions linked to motor and cognitive impairments and permanent disabilities. Presently, MRI is used to assess active/inactive CNS lesions. Although informative for diagnosis, such measures do not correlate well with clinical symptoms or with MS progression. Given the importance of inflammation and oxidative stress in MS1, new non-ionizing imaging methods providing insights on these pathogenic processes would improve patient management and treatment. Hyperpolarization increases the MR signal of 13C probes by >50,000, overcoming the inherently limited sensitivity of endogenous 13C and enables the monitoring of metabolic reactions in the brain in real time in vivo. HP 13C MR was first developed for oncology2,3, and in the last decade, has improved the non-invasive detection of neoplasms through monitoring of increased HP [1-13C]pyruvate to lactate conversion in preclinical models and in the clinic.4-6 A phase I study to assess the safety and tolerability of HP 13C pyruvate injection in healthy volunteers was completed in December 2007, as well as a second safety study in patients over the age of 60 with the majority of subjects tolerating the injection well and the only serious adverse effect being "flushing" with changes in systolic and diastolic blood pressure, thought to be secondary to a baroreflex response. Throughout the study, data on serum biochemistry variables and post-dosing changes were unremarkable, and no notable changes in vital signs, hematology, urinalysis, electrocardiogram (EKG) variables or other safety variables were registered. This has further been validated in men with localized prostate cancer in a UCSF phase I study. In the present study, each subject will receive HP 13C pyruvate injection at a dosage of 0.43 mL/kg body weight, which was the administered dose in the prior UCSF phase I study in prostate cancer (NCT01229618). Over 1,000 patients have been safely scanned with HP 13C pyruvate injection before March 2026.
- Conditions
- Multiple Sclerosis, RRMS, Relapsing Remitting MS
- Being tested
- HP 13C pyruvate injection, MRI Scanner
- Keywords
- Hyperpolarized Carbon, Multiple Sclerosis, Anti-CD20, Ocrevus, RRMS, MS, Metabolic Imaging, Hyperpolarized Pyruvate, MRI, Magnetic Resonance Imaging, UCSF, Ari Green, Relapsing Remitting MS, ocrelizumab, Jeremy Gordon, MS biomarker, MS prognosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HP 13C pyruvate injectionDrug
Each participant will receive HP 13C pyruvate injection at a dosage of 0.43 mL/kg body weight during the MRI scan. A subset of subjects will undergo a repeatability study with a second HP 13C pyruvate injection at the same dosage.
13C is a stable, non-radioactive isotope of carbon with approximately 1% natural abundance. [1-13C] pyruvate has the same chemical characteristics as pyruvate. In [1-13C] pyruvate, the C-1 carbonyl has been replaced by a 13C-nucleus. These enriched isotopes have a magnetic moment and can be hyperpolarized in the presence of an EPA, i.e., AH111501 sodium salt (a stable trityl radical) by dynamic nuclear polarization (DNP) technique. As [1-13C] pyruvate has the same chemical characteristics as pyruvate, it is metabolized the same way. The polarization procedure allows MR imaging to rapidly detect the hyperpolarized 13C-label in [1-13C] pyruvate and its metabolites, [1-13C] lactate, [1-13C] alanine, and [13C] bicarbonate.
MRI ScannerDevice
MRI Brain scan
| Study group | Role | What they receive |
|---|---|---|
| HP13C MRI | Other | 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. Receives: Drug: HP 13C pyruvate injection; Device: MRI Scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the percent changes in MS lesions, white matter, and whole brain HP 13C pyruvate metabolism measures between the pre-treatment scan and the scan obtained 1.5-months following treatment initiation.
Percent changes in lesion HP 13C pyruvate metabolism measures. The following metabolism measures will be assessed at baseline and at 1.5-months following treatment initiation
- Peak HP 13C lactate/pyruvate and bicarbonate/pyruvate signal-to-noise ratio
- HP 13C lactate/pyruvate and bicarbonate/pyruvate AUC ratio
- Metabolic rate constants kPL and kPB in inverse seconds.
Measured: From study initiation to up to 15 months after enrollment of last subject.
Secondary outcomes (3)
To determine the percent changes in MS lesions, white matter, and whole brain HP 13C pyruvate metabolism measures between the pre-treatment scan and the scan obtained 3-months and one year following treatment initiation.
Percent changes in lesion HP 13C pyruvate metabolism measures. The following metabolism measures will be assessed at baseline and at 3-months and one year following treatment initiation
- Peak HP 13C lactate/pyruvate and bicarbonate/pyruvate signal-to-noise ratio
- HP 13C lactate/pyruvate and bicarbonate/pyruvate AUC ratio
- Metabolic rate constants kPL and kPB in inverse seconds
Measured: From study initiation to up to 15 months after enrollment of last subject.
To determine the repeatability of HP 13C pyruvate metabolism measures in the MS lesions in patients with same-day repeated dose.
Repeatability of HP 13C pyruvate metabolism measures in the MS lesions
The following metabolism measures will be assessed as repeat measures:
- Peak HP 13C lactate/pyruvate and bicarbonate/pyruvate signal-to-noise ratio
- HP 13C lactate/pyruvate and bicarbonate/pyruvate AUC ratio
- Metabolic rate constants kPL and kPB in inverse seconds
Measured: From study initiation to 15 months after enrollment of last subject.
To determine the repeatability of HP 13C pyruvate metabolism measures in the MS lesions in patients with same-day repeated dose.
Repeatability of HP 13C pyruvate metabolism measures in the MS lesions
The following metabolism measures will be assessed as repeat measures:
- Peak HP 13C lactate/pyruvate and bicarbonate/pyruvate ratio
- HP 13C lactate/pyruvate and bicarbonate/pyruvate AUC ratio
- Metabolic rate constants kPL and kPB in inverse seconds
Measured: From study initiation to 15 months after enrollment of last subject.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start3 Jun 2026
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ari Green
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor-investigator, Ari Green, University of California, San Francisco
- Investigators
- Ari Green, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510607
- Sponsor's protocol ID
- 25-44242
- Other IDs
- R01NS102156
- Acronym
- MIIMS
- Status last verified
- Jun 2026
- First submitted
- 26 Mar 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified study data that underlies the results reported will be made available to qualified researchers. This includes the individual-level data required to replicate the primary and secondary outcome measures as defined in the statistical analysis plan. Proposals should be directed to the Principal Investigator; to gain access, data requestors will need to sign a data access agreement
Publications
Ohl K, Tenbrock K, Kipp M. Oxidative stress in multiple sclerosis: Central and peripheral mode of action. Exp Neurol. 2016 Mar;277:58-67. doi: 10.1016/j.expneurol.2015.11.010. Epub 2015 Nov 26.
PubMed 26626971Golman K, in 't Zandt R, Thaning M. Real-time metabolic imaging. Proc Natl Acad Sci U S A. 2006 Jul 25;103(30):11270-5. doi: 10.1073/pnas.0601319103. Epub 2006 Jul 12.
PubMed 16837573Nelson SJ, Kurhanewicz J, Vigneron DB, Larson PE, Harzstark AL, Ferrone M, van Criekinge M, Chang JW, Bok R, Park I, Reed G, Carvajal L, Small EJ, Munster P, Weinberg VK, Ardenkjaer-Larsen JH, Chen AP, Hurd RE, Odegardstuen LI, Robb FJ, Tropp J, Murray JA. Metabolic imaging of patients with prostate cancer using hyperpolarized [1-(1)(3)C]pyruvate. Sci Transl Med. 2013 Aug 14;5(198):198ra108. doi: 10.1126/scitranslmed.3006070.
PubMed 23946197Tang S, Meng MV, Slater JB, Gordon JW, Vigneron DB, Stohr BA, Larson PEZ, Wang ZJ. Metabolic imaging with hyperpolarized 13 C pyruvate magnetic resonance imaging in patients with renal tumors-Initial experience. Cancer. 2021 Aug 1;127(15):2693-2704. doi: 10.1002/cncr.33554. Epub 2021 Apr 12.
PubMed 33844280Park I, Larson PEZ, Gordon JW, Carvajal L, Chen HY, Bok R, Van Criekinge M, Ferrone M, Slater JB, Xu D, Kurhanewicz J, Vigneron DB, Chang S, Nelson SJ. Development of methods and feasibility of using hyperpolarized carbon-13 imaging data for evaluating brain metabolism in patient studies. Magn Reson Med. 2018 Sep;80(3):864-873. doi: 10.1002/mrm.27077. Epub 2018 Jan 10.
PubMed 29322616Gordon JW, Chen HY, Nickles T, Lee PM, Bok R, Ohliger MA, Okamoto K, Ko AH, Larson PEZ, Wang ZJ. Hyperpolarized 13C Metabolic MRI of Patients with Pancreatic Ductal Adenocarcinoma. J Magn Reson Imaging. 2024 Aug;60(2):741-749. doi: 10.1002/jmri.29162. Epub 2023 Dec 2.
PubMed 38041836
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Metabolic Changes in Multiple Sclerosis Using Hyper-polarized Carbon 13 MRI
- ClinicalTrials.gov ID
- NCT07510607
- Acronym / sponsor ID
- MIIMS / 25-44242
- Conditions
- Multiple Sclerosis, RRMS, Relapsing Remitting MS
- Keywords
- Hyperpolarized Carbon, Multiple Sclerosis, Anti-CD20, Ocrevus, RRMS, MS, Metabolic Imaging, Hyperpolarized Pyruvate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ari GreenUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. A total of 40 relapse-remitting (RRMS) patients naïve to DMT and starting on an anti-CD20 therapy as part of their routine MS clinical care will be recruited. In a preliminary cohort, 8 patients will be imaged once to optimize HP 13C MR parameters for improved spatial and temporal resolution. Using these sequence parameters, we will then image 32 RRMS patients who will undergo a baseline anatomic and HP 13C pyruvate MRI scan prior to receiving 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.
Multiple Sclerosis (MS) is the most prevalent chronic inflammatory disease of the central nervous system (CNS) among adults, characterized by demyelinating lesions linked to motor and cognitive impairments and permanent disabilities. Presently, MRI is used to assess active/inactive CNS lesions. Although informative for diagnosis, such measures do not correlate well with clinical symptoms or with MS progression. Given the importance of inflammation and oxidative stress in MS1, new non-ionizing imaging methods providing insights on these pathogenic processes would improve patient management and treatment. Hyperpolarization increases the MR signal of 13C probes by >50,000, overcoming the inherently limited sensitivity of endogenous 13C and enables the monitoring of metabolic reactions in the brain in real time in vivo. HP 13C MR was first developed for oncology2,3, and in the last decade, has improved the non-invasive detection of neoplasms through monitoring of increased HP [1-13C]pyruvate to lactate conversion in preclinical models and in the clinic.4-6 A phase I study to assess the safety and tolerability of HP 13C pyruvate injection in healthy volunteers was completed in December 2007, as well as a second safety study in patients over the age of 60 with the majority of subjects tolerating the injection well and the only serious adverse effect being "flushing" with changes in systolic and diastolic blood pressure, thought to be secondary to a baroreflex response. Throughout the study, data on serum biochemistry variables and post-dosing changes were unremarkable, and no notable changes in vital signs, hematology, urinalysis, electrocardiogram (EKG) variables or other safety variables were registered. This has further been validated in men with localized prostate cancer in a UCSF phase I study. In the present study, each subject will receive HP 13C pyruvate injection at a dosage of 0.43 mL/kg body weight, which was the administered dose in the prior UCSF phase I study in prostate cancer (NCT01229618). Over 1,000 patients have been safely scanned with HP 13C pyruvate injection before March 2026.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HP13C MRI | Other | Drug: HP 13C pyruvate injection, Device: MRI Scanner8 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
- History of clinically significant EKG abnormalities, including QT prolongation or a family history of prolonged QT syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HP 13C pyruvate injectionEach participant will receive HP 13C pyruvate injection at a dosage of 0.43 mL/kg body weight during the MRI scan. A subset of subjects will undergo a repeatability study with a second HP 13C pyruvate injection at the same dosage. 13C is a stable, non-radioactive isotope of carbon with approximately 1% natural abundance. [1-13C] pyruvate has the same chemical characteristics as pyruvate. In [1-13C] pyruvate, the C-1 carbonyl has been replaced by a 13C-nucleus. These enriched isotopes have a magnetic moment and can be hyperpolarized in the presence of an EPA, i.e., AH111501 sodium salt (a stable trityl radical) by dynamic nuclear polarization (DNP) technique. As [1-13C] pyruvate has the same chemical characteristics as pyruvate, it is metabolized the same way. The polarization procedure allows MR imaging to rapidly detect the hyperpolarized 13C-label in [1-13C] pyruvate and its metabolites, [1-13C] lactate, [1-13C] alanine, and [13C] bicarbonate. | Drug | HP13C MRI |
| MRI ScannerMRI Brain scan | Device | HP13C MRI |
Primary outcome
To determine the percent changes in MS lesions, white matter, and whole brain HP 13C pyruvate metabolism measures between the pre-treatment scan and the scan obtained 1.5-months following treatment initiation.
Time frame: From study initiation to up to 15 months after enrollment of last subject.
Percent changes in lesion HP 13C pyruvate metabolism measures. The following metabolism measures will be assessed at baseline and at 1.5-months following treatment initiation * Peak HP 13C lactate/pyruvate and bicarbonate/pyruvate signal-to-noise ratio * HP 13C lactate/pyruvate and bicarbonate/pyruvate AUC ratio * Metabolic rate constants kPL and kPB in inverse seconds.
3 secondary outcomes
To determine the percent changes in MS lesions, white matter, and whole brain HP 13C pyruvate metabolism measures between the pre-treatment scan and the scan obtained 3-months and one year following treatment initiation.
Time frame: From study initiation to up to 15 months after enrollment of last subject.
To determine the repeatability of HP 13C pyruvate metabolism measures in the MS lesions in patients with same-day repeated dose.
Time frame: From study initiation to 15 months after enrollment of last subject.
To determine the repeatability of HP 13C pyruvate metabolism measures in the MS lesions in patients with same-day repeated dose.
Time frame: From study initiation to 15 months after enrollment of last subject.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Background: PubMed 26626971Ohl K, Tenbrock K, Kipp M. Oxidative stress in multiple sclerosis: Central and peripheral mode of action. Exp Neurol. 2016 Mar;277:58-67. doi: 10.1016/j.expneurol.2015.11.010. Epub 2015 Nov 26.
- Background: PubMed 16837573Golman K, in 't Zandt R, Thaning M. Real-time metabolic imaging. Proc Natl Acad Sci U S A. 2006 Jul 25;103(30):11270-5. doi: 10.1073/pnas.0601319103. Epub 2006 Jul 12.
- Background: PubMed 23946197Nelson SJ, Kurhanewicz J, Vigneron DB, Larson PE, Harzstark AL, Ferrone M, van Criekinge M, Chang JW, Bok R, Park I, Reed G, Carvajal L, Small EJ, Munster P, Weinberg VK, Ardenkjaer-Larsen JH, Chen AP, Hurd RE, Odegardstuen LI, Robb FJ, Tropp J, Murray JA. Metabolic imaging of patients with prostate cancer using hyperpolarized [1-(1)(3)C]pyruvate. Sci Transl Med. 2013 Aug 14;5(198):198ra108. doi: 10.1126/scitranslmed.3006070.
- Background: PubMed 33844280Tang S, Meng MV, Slater JB, Gordon JW, Vigneron DB, Stohr BA, Larson PEZ, Wang ZJ. Metabolic imaging with hyperpolarized 13 C pyruvate magnetic resonance imaging in patients with renal tumors-Initial experience. Cancer. 2021 Aug 1;127(15):2693-2704. doi: 10.1002/cncr.33554. Epub 2021 Apr 12.
- Background: PubMed 29322616Park I, Larson PEZ, Gordon JW, Carvajal L, Chen HY, Bok R, Van Criekinge M, Ferrone M, Slater JB, Xu D, Kurhanewicz J, Vigneron DB, Chang S, Nelson SJ. Development of methods and feasibility of using hyperpolarized carbon-13 imaging data for evaluating brain metabolism in patient studies. Magn Reson Med. 2018 Sep;80(3):864-873. doi: 10.1002/mrm.27077. Epub 2018 Jan 10.
- Background: PubMed 38041836Gordon JW, Chen HY, Nickles T, Lee PM, Bok R, Ohliger MA, Okamoto K, Ko AH, Larson PEZ, Wang ZJ. Hyperpolarized 13C Metabolic MRI of Patients with Pancreatic Ductal Adenocarcinoma. J Magn Reson Imaging. 2024 Aug;60(2):741-749. doi: 10.1002/jmri.29162. Epub 2023 Dec 2.
- Individual participant dataSharing planned: Yes. De-identified study data that underlies the results reported will be made available to qualified researchers. This includes the individual-level data required to replicate the primary and secondary outcome measures as defined in the statistical analysis plan. Proposals should be directed to the Principal Investigator; to gain access, data requestors will need to sign a data access agreement
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ari Green, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HP 13C pyruvate injection and MRI Scanner in people with Multiple Sclerosis and RRMS, run by Ari Green at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the percent changes in MS lesions, white matter, and whole brain HP 13C pyruvate metabolism measures between the pre-treatment scan and the scan obtained 1.5-months following treatment initiation. (time frame: From study initiation to up to 15 months after enrollment of last subject.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07510607, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.