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Recruiting NCT06014905

Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma

Phase I Interventional Meningioma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hyperpolarized carbon C 13 pyruvate, Magnetic Resonance Image (MRI), Saline.
Who it may be relevant to
Registry conditions: Meningioma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Detailed description

Primary Objective:

I. 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:

I. 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.

Interventions

  • Drug Hyperpolarized carbon C 13 pyruvate
    Given Intravenously (IV)
  • Procedure Magnetic Resonance Image (MRI)
    Imaging procedure
  • Other Saline
    Given IV

Primary outcome measures

  • Proportion of participants who complete 13C pyruvate MR imaging. [Time frame: Day of MR imaging (1 day)]
Secondary outcome measures (6)
  • Best Magnetic Resonance (MR) imaging protocol ("measurement") to detect altered pyruvate-to-lactate cell metabolism [Time frame: Day of MR imaging (1 day)]
  • Best Magnetic Resonance (MR) imaging protocol ("measurement") to detect altered pyruvate-to-alanine cell metabolism [Time frame: Day of MR imaging (1 day)]
  • Best Magnetic Resonance (MR) imaging protocol ("measurement") to detect altered pyruvate-to-bicarbonate cell conversion [Time frame: Day of MR imaging (1 day)]
  • Mean of pyruvate-to-lactate [Time frame: Day of MR imaging (1 day)]
  • Mean of pyruvate-to-alanine [Time frame: Day of MR imaging (1 day)]
  • Mean of pyruvate-to-bicarbonate conversion [Time frame: Day of MR imaging (1 day)]

Eligibility criteria

Inclusion criteria

  • 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

  • Participants cannot have contraindication to MRI examinations.
  • Age >=18 years.
  • Have a life expectancy of >12 weeks.
  • Karnofsky Performance Status > 60%.
  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • University of California, San Francisco — San Francisco

Identifiers

NCT: NCT06014905 · 23924 · NCI-2023-05550 · 5R21EB030899-02 · 2P01CA118816-11A1 · 2P01CA118816-16

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗