Summary

for people ages 19 years and up (full criteria)
at San Francisco, California
study started
estimated completion:
Susan Chang

Description

Summary

This pilot trial studies the side effects of hyperpolarized carbon C 13 pyruvate magnetic resonance imaging (MRI) in diagnosing participants with glioma. Diagnostic procedures, such as hyperpolarized carbon C 13 pyruvate MRI, may help find and diagnose glioma.

Official Title

Pilot Study of Safety and Feasibility of Acquiring Hyperpolarized Imaging in Patients With Gliomas

Details

PRIMARY OBJECTIVES:

  1. To assess the safety and feasibility of hyperpolarized carbon C 13 (13C) magnetic resonance (MR) metabolic imaging as a new and unique tool for evaluating tumor burden and detecting early response to standard therapy in patients with glioma.

II. To define the most appropriate imaging parameters for obtaining hyperpolarized 13C data from the brain, sixty patients with evidence of residual disease from a prior MRI examination will be scanned with a slice select magnetic resonance spectroscopic (MRS) sequence, a dynamic 2dimensional (D) magnetic resonance spectroscopic imaging (MRSI) or a single time point 3D MRSI sequence after receiving an injection of hyperpolarized 13C pyruvate.

III. To establish the time course of changes in hyperpolarized pyruvate and lactate peaks on a voxel by voxel basis using dynamic 2D MRSI.

IV. To evaluate if patients who receive treatment with standard radiation and temozolomide exhibit a reduction in hyperpolarized 13C lactate/pyruvate at post-radiation follow-up compared to their baseline scan.

OUTLINE: Participants are assigned to 1 of 2 cohorts.

COHORT I: Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) and undergo MRI.

COHORT II: Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRI before standard treatment with radiation therapy and temozolomide and 4 weeks after completion of radiation therapy.

After completion of study treatment, participants are followed for up to 24 months.

Keywords

Glioma Temozolomide Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Imaging Radiation Therapy

Eligibility

You can join if…

Open to people ages 19 years and up

  • FOR PATIENTS IN COHORT 1: Histologically proven glioma who have evidence of evaluable disease based on a prior MR scan.
  • FOR PATIENTS IN COHORT 2: Histologically proven glioma who will be undergoing standard treatment with radiation and temozolomide.
  • A life expectancy > 12 weeks.
  • Patients must have a Karnofsky performance status of >= 60.
  • White blood cell (WBC) > 3,000/ul within 14 days prior to hyperpolarized imaging scan.
  • Absolute neutrophil count (ANC) > 1,500/mm3 within 14 days prior to hyperpolarized imaging scan.

  • Platelet count of > 100,000/mm3 within 14 days prior to hyperpolarized imaging scan.

  • Hemoglobin > 10 mg/dl within 14 days prior to hyperpolarized imaging scan.
  • Serum glutamic-oxaloacetic transaminase (SGOT) < 1.5 times upper limit of normal (ULN)within 14 days prior to hyperpolarized imaging scan.
  • Bilirubin < 1.5 times ULN within 14 days prior to hyperpolarized imaging scan.
  • Creatinine < 1.5 mg/dL within 14 days prior to hyperpolarized imaging scan.
  • Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the patient's ability to tolerate the imaging examination or any disease that will obscure toxicity or dangerously alter response to the imaging agent.
  • Patients must not have New York Heart Association (NYHA) grade II or greater congestive heart failure.
  • Patients must not have a history of myocardial infarction or unstable angina within 12 months prior to study enrollment.
  • Patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must sign an authorization for the release of their protected health information.
  • Patients may not be known to be human immunodeficiency virus (HIV)-positive. HIV testing is not required for study participation.
  • Patients must not have 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.
  • Patients 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 subjects of child-bearing potential.

You CAN'T join if...

  • Subjects must be excluded from participating in this study if they are not able to comply with study and/or follow-up procedures.

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94115 United States

Lead Scientist

  • Susan Chang
    Professor, Neurological Surgery. Authored (or co-authored) 194 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Susan Chang
ID
NCT03739411
Phase
Phase 1
Study Type
Interventional
Last Updated