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MeningiomaPhase 1NCT06014905

Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma

A Phase 1 study testing Hyperpolarized carbon C 13 pyruvate, Magnetic Resonance Image (MRI) and Saline in people with Meningioma, run by Charlie Wang, MD, PhD at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a Pilot/Phase I clinical study of hyperpolarized 13C (HP 13C) pyruvate injection that includes the acquisition of magnetic resonance (MR) data performed on participants with meningioma to evaluate metabolism and aid in the non-invasive characterization of aggressive tumor behavior Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Meningioma
What is being tested?
Hyperpolarized carbon C 13 pyruvate, Magnetic Resonance Image (MRI) and Saline
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
1 Sep 2023to 30 Sep 2027
Phase
Phase 1
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
  • Thirty of the participants plan to have surgical resection within 4 weeks
  • Participants cannot have contraindication to MRI examinations.
  • Age >=18 years.
  • Have a life expectancy of >12 weeks.
  • Karnofsky Performance Status > 60%.
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  • Participants must have adequate renal function (creatinine < 1.5 mg/dL) before imaging. This test must be performed within 60 days prior to hyperpolarized imaging scan.
  • Participants must sign an informed consent indicating that they are aware of the investigational nature of this study.
  • Participants must sign an authorization for the release of their protected health information.

Who cannot join

  • Has any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the patient's ability to participate in this study or any disease that will obscure toxicity or dangerously impact response to the imaging agent.
  • Uncontrolled blood pressure (Systolic BP≥140 mmHg or diastolic BP ≥>=90 mmHg) despite an optimized regimen of antihypertensive medication.
  • 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.
  • Participants must not be pregnant or breast feeding. Women of childbearing potential are required to obtain a negative pregnancy test within 14 days of Hyperpolarized Imaging scan. Effective contraception (men and women) must be used in participants of child-bearing potential.
  • Participants must be excluded from participating in the study if they are not able to comply with the study and/or follow-up procedures.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wendy Ma contact

(415) 514-4418

Wendy.Ma@ucsf.edu

United States1 site, 1 recruiting

  • University of California, San Francisco

    San Francisco, California, 94143

    Wendy Ma, (415) 514-4418, Wendy.Ma@ucsf.edu

    877-827-3222, cancertrials@ucsf.edu

    Recruiting

Other trials in United States

About this study

Official title: Pilot/Phase I Study of Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma

This is a Pilot/Phase I clinical study of hyperpolarized 13C (HP 13C) pyruvate injection that includes the acquisition of magnetic resonance (MR) data performed on participants with meningioma to evaluate metabolism and aid in the non-invasive characterization of aggressive tumor behavior

Read the detailed description

Primary Objective:

  1. To assess the feasibility of hyperpolarized 13C MR imaging as a new and unique tool in the characterization of aggressive tumor behavior in participants with meningioma.

Secondary Objectives:

  1. To define the most appropriate parameters for obtaining hyperpolarized 13C data from meningioma patients with a run-in study to optimize spatial and temporal resolution and coverage by detecting signal amplitudes and time dynamics.

II. To measure tumor pyruvate-to-lactate, pyruvate-to-alanine, and pyruvate-to-bicarbonate conversion by 13C pyruvate MR imaging in participants with meningioma planning to undergo surgical resection within 4 weeks, using parameters.

Outline:

Participants will receive a single imaging procedure using HP 13C pyruvate. Participants will then be followed-up for 30 days after completion of the study or until voluntary withdrawal or death.

Conditions
Meningioma
Being tested
Hyperpolarized carbon C 13 pyruvate, Magnetic Resonance Image (MRI), Saline
Medical subject headings
Meningioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyperpolarized carbon C 13 pyruvateDrug

    Also called Hyperpolarized 13C-Pyruvate, HP C13 pyruvate

    Given Intravenously (IV)

  • Magnetic Resonance Image (MRI)Procedure or surgery

    Also called MR

    Imaging procedure

  • SalineOther

    Also called Saline Flush

    Given IV

Study groups in NCT06014905
Study groupRoleWhat they receive
Hyperpolarized 13C pyruvate, Magnetic Resonance ImagingExperimentalParticipants 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.
Receives: Drug: Hyperpolarized carbon C 13 pyruvate; Procedure: Magnetic Resonance Image (MRI); Other: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants who complete 13C pyruvate MR imaging.

    All participants who are enrolled in the study and receive any amount of hyperpolarized 13C pyruvate will be included in the primary outcome analysis. The proportion of participants who complete hyperpolarized 13C pyruvate MR imaging will be reported. If the proportion is greater than 0.7, hyperpolarized 13C MR imaging will be determined to be feasible.

    Measured: Day of MR imaging (1 day)

Secondary outcomes (6)

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

    Five initial patients will be evaluated to establish the spatial and temporal resolution and coverage that yields the best signal amplitudes and time dynamics for measuring tumor pyruvate-to-lactate will be identified.

    Measured: Day of MR imaging (1 day)

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

    Five initial patients will be evaluated to establish the spatial, temporal resolution and coverage that yield the best signal amplitudes and time dynamics for measuring tumor pyruvate-to-alanine will be identified.

    Measured: Day of MR imaging (1 day)

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

    Five initial patients will be evaluated to establish the spatial and temporal resolution and coverage that yield the best signal amplitudes and time dynamics for measuring tumor pyruvate-to-bicarbonate conversion will be identified.

    Measured: Day of MR imaging (1 day)

  4. Mean of pyruvate-to-lactate

    The mean and standard deviations of pyruvate-to-lactate ratio will be reported.

    Measured: Day of MR imaging (1 day)

  5. Mean of pyruvate-to-alanine

    The mean and standard deviations of pyruvate-to-alanine ratio will be reported.

    Measured: Day of MR imaging (1 day)

  6. Mean of pyruvate-to-bicarbonate conversion

    The mean and standard deviations of pyruvate-to-bicarbonate conversion rate will be reported.

    Measured: Day of MR imaging (1 day)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2023
  2. Study start1 Sep 2023
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

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 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06014905
Sponsor's protocol ID
23924
Other IDs
NCI-2023-05550, 5R21EB030899-02, 2P01CA118816-11A1, 2P01CA118816-16
Status last verified
Aug 2026
First submitted
11 Aug 2023
Last updated
14 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Hyperpolarized carbon C 13 pyruvate, Magnetic Resonance Image (MRI) and Saline in people with Meningioma, run by Charlie Wang, MD, PhD 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 9 inclusion and 5 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 14 Aug 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Contact Wendy Ma ((415) 514-4418, Wendy.Ma@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants who complete 13C pyruvate MR imaging. (time frame: Day of MR imaging (1 day)). 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 NCT06014905.

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 14 Aug 2026.

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