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New treatment option for Multiple Sclerosis
Official title Hyperpolarized Carbon Metabolic Imaging in Multiple Sclerosis
ClinicalTrials.gov ID: NCT07510607
What this study is testing
What is HP 13C pyruvate injection?
HP 13C pyruvate injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for multiple sclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- people 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 enrolled will be screened for at least one MS lesion with a 10mm diameter in one plane.
You likely can't join if
- 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...
- Poorly controlled hypertension, defined as either systolic \>160 or diastolic \>110. The addition of anti-hypertensives to control blood pressure is...
- 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.
See the full eligibility criteria
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- people 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...
- Patients enrolled will be screened for at least one MS lesion with a 10mm diameter in one plane.
- 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.
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.