Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma

a study on Meningioma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Javier Villanueva-Meyer, MD
Headshot of Javier Villanueva-Meyer
Javier Villanueva-Meyer

Description

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

Official Title

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

Details

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.

Keywords

Meningioma, Hyperpolarized carbon C 13 pyruvate, Magnetic Resonance Image (MRI), Saline, Hyperpolarized 13C pyruvate, Magnetic Resonance Imaging

Eligibility

You can join if…

Open to people ages 18 years and up

  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).
  2. Participants cannot have contraindication to MRI examinations.
  3. Age >=18 years.
  4. Have a life expectancy of >12 weeks.
  5. Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky >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. Patients must sign an authorization for the release of their protected health information.

You CAN'T join if...

  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. Has New York Heart Association (NYHA) Grade II or greater congestive heart failure.
  3. Has history of myocardial infarction or unstable angina within 12 months prior to study enrollment.
  4. Uncontrolled blood pressure (Systolic BP≥140 mmHg or diastolic BP ≥>=90 mmHg) despite an optimized regimen of antihypertensive medication.
  5. 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.
  6. 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.
  7. Participants must be excluded from participating in the study if they are not able to comply with the study and/or follow-up procedures.

Location

  • UCSF accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Javier Villanueva-Meyer, MD
    Javier Villanueva­-Meyer, MD, is an Associate Professor in the Neuroradiology section in the Department of Radiology and Biomedical Imaging at the University of California, San Francisco. He received his medical degree from Baylor College of Medicine in Houston, Texas, and he completed his one-year internship at Virginia Tech Carilion School of Medicine in Roanoke.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Javier Villaneuva-Meyer, MD
ID
NCT06014905
Phase
Phase 1 Meningioma Research Study
Study Type
Interventional
Participants
Expecting 25 study participants
Last Updated
Contact us about this trial