RECRUITING

Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma

Description

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

Study Overview

Study Details

Study 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

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

Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma

Condition
Meningioma
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Javier Villaneuva-Meyer, MD,

Javier Villanueva-Meyer, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

2025-09-30