No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Other
Participants needed
40 (estimated)
Sponsor
Ari Green · Other
Who this trial is looking for
This trial is looking for adults with relapsing remitting multiple sclerosis who have not been treated with disease-modifying therapies for at least two years. Participants will undergo imaging and assessments to help understand how their disease is progressing and how they might respond to a specific therapy.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older.
I have relapsing remitting multiple sclerosis.
I have not been treated with any disease-modifying therapies for at least two years.
I am planning to start anti-CD20 therapy for my MS.
I have at least one MS lesion that is 10 mm in diameter.
You may not be able to join if
I have taken corticosteroids in the past 30 days.
I am unable or unwilling to undergo MRI imaging.
I have poorly controlled hypertension.
I have congestive heart failure.
I have had a significant heart problem, like a heart attack, in the last 6 months.
I am pregnant or breastfeeding.
I have a history of significant cancer or chemotherapy in the past 5 years.
I have a glomerular filtration rate of less than 60.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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Status
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 …
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
Contacts
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