Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma

Part of paid clinical trials in San Francisco, California.

Sponsor
Javier Villaneuva-Meyer, MD
Study ID
NCT06014905
Phase
PHASE1
Status
Recruiting
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Conditions

  • Meningioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hyperpolarized carbon C 13 pyruvate — DRUG
    Given Intravenously (IV)
  • Magnetic Resonance Image (MRI) — PROCEDURE
    Imaging procedure
  • Saline — OTHER
    Given IV

Study Details

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

Key Dates

Start date
Sep 1, 2023
Status verified
May 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Wendy Ma
[email protected]
(415) 514-4418
[email protected]
877-827-3222
Javier Villanueva-Meyer, MD (PRINCIPAL_INVESTIGATOR)

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