Recruiting
Phase 1

HP 13C Pyruvate

Sponsor:

Charlie Wang, MD, PhD

Code:

NCT06014905

Conditions

Meningioma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hyperpolarized carbon C 13 pyruvate

Magnetic Resonance Image (MRI)

Saline

Study Details

Brief 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

Conditions

Meningioma

Study ID

NCT06014905

Start date

Sep 1, 2023

Status verified date

Aug, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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).

a. Thirty of the participants plan to have surgical resection within 4 weeks
2. Participants cannot have contraindication to MRI examinations.
3. Age >=18 years.
4. Have a life expectancy of >12 weeks.
5. Karnofsky Performance Status > 60%.
6. 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.
7. Participants must sign an informed consent indicating that they are aware of the investigational nature of this study.
8. Participants must sign an authorization for the release of their protected health information.

Exclusion Criteria:

1. 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.
2. Uncontrolled blood pressure (Systolic BP≥140 mmHg or diastolic BP ≥>=90 mmHg) despite an optimized regimen of antihypertensive medication.
3. 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.
4. 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.
5. Participants must be excluded from participating in the study if they are not able to comply with the study and/or follow-up procedures.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Hyperpolarized 13C pyruvate, Magnetic Resonance Imaging

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.

Interventions

Hyperpolarized carbon C 13 pyruvate

Given Intravenously (IV)

Magnetic Resonance Image (MRI)

Imaging procedure

Saline

Given IV

Primary outcome measure

  • Proportion of participants who complete 13C pyruvate MR imaging. [ Time Frame: Day of MR imaging (1 day) ]

Central Contacts and Locations

Central contacts

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Principal Investigator:

Charlie Wang, MD, PhD

More Information

Sponsor

Charlie Wang, MD, PhD

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Charlie Wang, MD, PhD on 2026-08-14.