Recruiting
Phase 1

Observational Study

Sponsor:

Susan Chang

Code:

NCT04540107

Conditions

Recurrent World Health Organization (WHO) Grade II Glioma

Recurrent WHO Grade III Glioma

WHO Grade II Glioma

WHO Grade III Glioma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hyperpolarized Carbon C 13 Pyruvate

Magnetic Resonance Imaging

Magnetic Resonance Spectroscopic Imaging

Study Details

Brief summary:

This trial studies how well serial magnetic resonance (MR) imaging and MR spectroscopic imaging work in characterizing lower grade glioma. Diagnostic procedures, such as MR imaging and MR spectroscopic imaging, may detect serial changes in lower grade glioma. This study may help researchers learn more about practical ways of evaluating and standardizing treatment in patients with brain tumors.

Conditions

Recurrent World Health Organization (WHO) Grade II Glioma

Recurrent WHO Grade III Glioma

WHO Grade II Glioma

WHO Grade III Glioma

Study ID

NCT04540107

Start date

Jan 11, 2017

Status verified date

Apr, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • For patients in cohort 1: histologically proven lower grade glioma who are being followed with surveillance scans
  • For patients in cohort 2: histologically proven glioma who are scheduled for treatment due to suspected residual or recurrent tumor
  • Patients with a life expectancy > 12 weeks
  • Patients must have a Karnofsky performance status of >= 60
  • Patients must have adequate renal function (creatinine < 1.5 mg/dL) before imaging. These tests must be performed within 60 days prior to the 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 participate in this study or any disease that will obscure toxicity or dangerously impact 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 history of myocardial infarction or unstable angina within 12 months prior to study enrollment
  • 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
  • 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 they are in complete remission and have been off 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

Exclusion Criteria:

  • Subjects will be excluded from participating in this study if they are unable to comply with study and/or follow-up procedures

Study Design

Enrollment

300 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Cohort 1 (MRI, MRSI) (CLOSED TO ENROLLMENT)

Patients undergo MRI and MRSI scans over 1 hour at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care. Participants enrolled in cohort 1 may later enroll in cohort 2 of study once eligibility has been reviewed and approved by neuro-oncologist

experimental: Cohort 2 (MRI, hyperpolarized carbon C 13 pyruvate, MRSI)

Patients undergo MRI scan at baseline. Patients then receive hyperpolarized carbon C 13 pyruvate IV over less than 1 minute and undergo MRSI scan at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care.

Interventions

Hyperpolarized Carbon C 13 Pyruvate

Given IV

Magnetic Resonance Imaging

Undergo MRI

Magnetic Resonance Spectroscopic Imaging

Undergo MRSI

Primary outcome measure

  • Number of treatment-emergent adverse events (AEs) [ Time Frame: Up to 4 years ]
  • Peak lactate/pyruvate [ Time Frame: Up to 4 years ]
  • Peak bicarbonate/pyruvate [ Time Frame: Up to 4 years ]
  • Change in peak lactate/pyruvate between scans [ Time Frame: Baseline up to 4 years ]
  • Change in peak bicarbonate/pyruvate between scans [ Time Frame: Baseline up to 4 years ]

Central Contacts and Locations

Central contacts

Wendy Ma

877-827-3222cancertrials@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Wendy Ma

877-827-3222cancertrials@ucsf.edu

Principal Investigator:

Susan M. Chang, MD

More Information

Sponsor

Susan Chang

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Keywords

  • Glioma
  • Hyperpolarized Pyruvate (13C)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Susan Chang on 2026-04-29.