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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)

Must not have

Has New York Heart Association (NYHA) Grade II or greater congestive heart failure

Has a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day of mr imaging (1 day)

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have moderate to severe heart failure.

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I've been cancer-free and off treatment for any other cancer than non-melanoma skin cancer or cervical carcinoma in-situ for at least 3 years.

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My blood pressure is high despite taking medication.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants who complete 13C pyruvate MR imaging.

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 6Eligibility criteria met