Summary

Eligibility
for people ages 19 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
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 13C MR metabolic imaging as a new and unique tool for evaluating tumor burden and detecting early response to standard therapy in patients with glioma.
  2. To define the most appropriate imaging parameters for obtaining hyperpolarized 13C data from the brain, one hundred patients with evidence of residual disease from a prior MRI examination will be scanned with either a slice select, a dynamic or a single time point MR sequence after receiving an injection of hyperpolarized 13C pyruvate.
  3. To establish the time course of changes in hyperpolarized pyruvate and lactate peaks on a voxel by voxel basis from the dynamic hyperpolarized data after the injection of hyperpolarized 13C pyruvate. Twenty patients will be studied before and after treatment with standard radiation and temozolomide in order to determine the time course of delivery of 13C pyruvate and the location of maximum pyruvate and lactate or glutamate signals in normal brain and in the region of T2 hyperintensity (T2L).
  4. To evaluate if patients who receive treatment with standard radiation and temozolomide exhibit a reduction in hyperpolarized 13C lactate/pyruvate or 13C glutamate/pyruvate at post-radiation follow-up compared to their baseline scan. A second group of twenty patients will be studied at the time determined from the prior group to provide the maximum contrast between lactate/pyruvate or glutamate/pyruvate in the lesion versus normal brain.

OUTLINE: Participants are assigned to 1 of 2 cohorts.

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

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 magnetic resonance (MR) scan.

For Patients in Cohort 2: Histologically proven glioma who will be undergoing standard treatment with radiation and temozolomide.

To be included in the study all subjects must also meet the following criteria:

  1. Patients must be > 18 years old and with a life expectancy > 12 weeks.
  2. Patients must have a Karnofsky performance status of ≥ 60.
  3. Patients must have adequate bone marrow function (Absolute Neutrophil Count (ANC) > 1,000/mm3, platelet count of > 100,000/mm3, and hemoglobin > 10 mg/dl), adequate liver function (serum glutamic-oxaloacetic transaminase (SGOT) and bilirubin < 1.5 times upper limit of normal (ULN)), and adequate renal function (creatinine < 1.5 mg/dL) before starting therapy. These tests must be performed within 14 days prior to Hyperpolarized Imaging scan.
  4. 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.
  5. Patients must not have New York Heart Association (NYHA) Grade II or greater congestive heart failure
  6. Patients must not have a history of myocardial infarction or unstable angina within 12 months prior to study enrollment.
  7. This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender. Minorities will actively be recruited to participate. No exclusion to this study will be based on race.
  8. 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.
  9. Patients may not be known to be human immunodeficiency virus (HIV)-positive. HIV testing is not required for study participation.
  10. . 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.
  11. . 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...

(1) 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 at UCSF

Details

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