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Virus Therapy

Hyperpolarized MRI for Meningioma

Phase 1

Recruiting

Led By Javier Villanueva-Meyer, MD

Research Sponsored by Javier Villaneuva-Meyer, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >=18 years

Known (histopathologically confirmed) or presumed meningioma based on imaging with measurable disease on MRI that shows gadolinium enhancement (at least one cm diameter) intracranially (e.g., not confined to skull base alone)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day of mr imaging (1 day)

Awards & highlights

Study Summary

This trial will use a new imaging technique to non-invasively study metabolism in meningiomas to help detect aggressive tumors.

Who is the study for?

Adults (18+) with confirmed or presumed meningioma based on MRI scans can join this trial. They should have a life expectancy over 12 weeks, be able to give informed consent, and not have any health issues that would interfere with the study. Pregnant or breastfeeding women are excluded, as well as those with recent heart problems, uncontrolled blood pressure, other cancers within the last 3 years, or an inability to follow study procedures.Check my eligibility

What is being tested?

The trial is testing a new imaging technique using hyperpolarized carbon C 13 pyruvate injections followed by MRI scans. This method aims to better understand meningioma metabolism and identify aggressive tumor behavior without invasive procedures.See study design

What are the potential side effects?

Since this is an imaging study involving MRI and hyperpolarized carbon C 13 pyruvate injection rather than drug treatment, side effects may include discomfort from lying still during the MRI and potential reactions at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My brain tumor is visible and confirmed on an MRI.

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I can do most activities by myself without help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day of mr imaging (1 day)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day of mr imaging (1 day)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day of mr imaging (1 day) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of participants who complete 13C pyruvate MR imaging.

Secondary outcome measures

Best Magnetic Resonance (MR) imaging protocol ("measurement") to detect altered pyruvate-to-alanine cell metabolism

Best Magnetic Resonance (MR) imaging protocol ("measurement") to detect altered pyruvate-to-bicarbonate cell conversion

Best Magnetic Resonance (MR) imaging protocol ("measurement") to detect altered pyruvate-to-lactate cell metabolism

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Hyperpolarized 13C pyruvate, Magnetic Resonance ImagingExperimental Treatment3 Interventions

Participants will receive a single research MR imaging using HP 13C pyruvate, intravenously injected at a rate of 5 ml/second followed by a 20-ml saline flush at 5 ml/second. Safety monitoring, including vital signs and symptom monitoring will be performed for 30 minutes after dosing is completed, 1 to 3 days after dosing, and up to 30 days post scanning procedure. During the follow-up period, study personnel will obtain clinical data from the participants' medical records.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute for Biomedical Imaging and Bioengineering (NIBIB)NIH

89 Previous Clinical Trials

19,726 Total Patients Enrolled

Javier Villaneuva-Meyer, MDLead Sponsor

General ElectricIndustry Sponsor

46 Previous Clinical Trials

12,372 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies still open for participating in the clinical trial?

"Per the information posted on clinicaltrials.gov, this research project is not currently enrolling participants. Initially published on September 1st 2023 and last updated August 23rd of the same year, this study has closed recruitment but 47 other trials are still actively recruiting individuals to participate in their experiments."

Answered by AI

Can any harm befall patients from undergoing Hyperpolarized 13C pyruvate, Magnetic Resonance Imaging?

"This novel imaging technology is undergoing Phase 1 clinical trials, so it has only been evaluated for preliminary safety and efficacy. Therefore, our team at Power rated Hyperpolarized 13C pyruvate Magnetic Resonance Imaging a score of 1 on the risk scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma

Javier Villaneuva-Meyer, MD 2023. "Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06014905.

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