Metabolic Imaging of Patients With Lower Grade Glioma Using Hyperpolarized 13C Pyruvate
Overview
- Phase
- Phase 1
- Intervention
- Magnetic Resonance Imaging
- Conditions
- Recurrent World Health Organization (WHO) Grade II Glioma
- Sponsor
- Susan Chang
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Number of treatment-emergent adverse events (AEs)
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Detailed Description
PRIMARY OBJECTIVES: I. To assess the safety and feasibility of hyperpolarized 13C MR metabolic imaging as a new and unique tool for making an early assessment of progression and evaluation of response to therapy in patients with lower grade glioma II. To determine whether changes in levels of hyperpolarized 13C pyruvate, lactate and bicarbonate may provide early evidence of tumor progression in patients with lower grade glioma who are being followed with surveillance scans. III. To determine whether patients with lower grade glioma who are receiving treatment exhibit a reduction in levels of hyperpolarized 13C lactate/pyruvate at follow-up compared to their baseline scan. OUTLINE: Patients will be enrolled into Cohort 2. Participants previously enrolled in Cohort 1 may enroll in Cohort 2 of study upon re-review of eligibility. COHORT 1 (CLOSED TO ENROLLMENT): Patients undergo MR imaging (MRI) and MR spectroscopic imaging (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. COHORT 2: Patients undergo MRI scan at baseline. Patients then receive hyperpolarized carbon C 13 pyruvate intravenously (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.
Investigators
Susan Chang
Principal Investigator
University of California, San Francisco
Eligibility Criteria
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
Exclusion Criteria
- •Subjects will be excluded from participating in this study if they are unable to comply with study and/or follow-up procedures
Arms & Interventions
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
Intervention: Magnetic Resonance Imaging
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
Intervention: Magnetic Resonance Spectroscopic Imaging
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.
Intervention: Hyperpolarized Carbon C 13 Pyruvate
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.
Intervention: Magnetic Resonance Imaging
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.
Intervention: Magnetic Resonance Spectroscopic Imaging
Outcomes
Primary Outcomes
Number of treatment-emergent adverse events (AEs)
Time Frame: Up to 4 years
Safety evaluation for endpoint will include monitoring for the occurrence of treatment-emergent adverse events (AEs). Reported toxicities will be graded using the National Cancer Institute (NCI) Common Terminology (Toxicity) Criteria for Adverse Events (CTCAE) version 4.0. All available safety data will be used and will be analyzed using descriptive statistics.
Peak lactate/pyruvate
Time Frame: Up to 4 years
The peak lactate/pyruvate in tumor and normal appearing brain tissue will be reported.
Peak bicarbonate/pyruvate
Time Frame: Up to 4 years
The peak bicarbonate/pyruvate in tumor and normal appearing brain tissue will be reported.
Change in peak lactate/pyruvate between scans
Time Frame: Baseline up to 4 years
The change in peak lactate/pyruvate between scans will be reported.
Change in peak bicarbonate/pyruvate between scans
Time Frame: Baseline up to 4 years
The change in peak bicarbonate/pyruvate between scans will be reported.