Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors

PRIMARY OBJECTIVES:

I. To establish a clinical infrastructure for performing hyperpolarized carbon C 13 pyruvate
(hyperpolarized 13-C-pyruvate) imaging in the human brain at MD Anderson.

SECONDARY OBJECTIVES:

I. To assess the correlation between conversion rate of hyperpolarized pyruvate to lactate
(kpl) values and Ki-67 quantitation in the tumor.

II. To compare kpl values between tumor and normal brain within patient. III. To assess the
association between kpl values and pathology results, including conventional, diffusion,
perfusion, and permeability imaging.

IV. To assess the association between kpl values and magnetic resonance (MR) imaging
findings.

V. To assess the association between kpl values and genomic findings, including methylation,
ribonucleic acid [RNA], and deoxyribonucleic acid [DNA]).

OUTLINE:

Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over 10-20 seconds
and then undergo an MRSI scan.

After completion of study, patients are followed up for 1 day.

Inclusion Criteria:

- All patients will be enrolled in study # 2011-0370, the Stereotactic RadPath trial.

- Agrees to participate in the clinical study and to complete all required visits and
evaluations. The pediatric population has a different disease profile from the glioma
patients investigators hope to recruit. To reduce heterogeneity in the patient
population nvestigators will not consider patients younger than 18 for this study.

- Patient is a candidate for cerebral tumor resection with lesion suspected to be or
previously biopsy proven to be a primary brain tumor.

- Patient is able to understand and give consent to participation in the study.

- Patient agrees to undergo, prior to the procedure, magnetic resonance imaging (MRI,
within 14 days and preferably with 3 days of the planned procedure) with perfusion,
diffusion and spectroscopic imaging.

- Patient has a glomerular filtration rate (GFR) > 60. In patients with moderate renal
failure (GFR 30-60), an alternate injection with 2 times half-dose multihance
(gadobenate dimeglumine) or gadovist (gadobutrol) will be considered, if a contrast
exam is deemed clinically necessary.

- Specifically for this study: Patient is willing to give signed informed consent for
C13-Pyruvate MR Spectroscopy.

Exclusion Criteria:

- The patient is found to have unfavorable anatomy to indicate that stereotactic biopsy
could not be safely performed.

- Pacemakers, electronic stimulation, metallic foreign bodies and devices and/or other
conditions that are not MR safe, which include but are not limited to:

- Electronically, magnetically, and mechanically activated implants

- Ferromagnetic or electronically operated active devices like automatic
cardioverter defibrillators and cardiac pacemakers

- Metallic splinters in the eye

- Ferromagnetic hemostatic clips in the central nervous system (CNS) or body

- Cochlear implants

- Other pacemakers, e.g., for the carotid sinus

- Insulin pumps and nerve stimulators

- Non-MR safe lead wires

- Prosthetic heart valves (if dehiscence is suspected)

- Non-ferromagnetic stapedial implants

- Pregnancy

- Claustrophobia that does not readily respond to oral medication

- Prior brain tumor treatment, including surgical resection, radiation therapy or
chemotherapy for a primary brain neoplasm. Previous biopsy will not disqualify the
patient from participation. Remote history (> 6 month) of non-CNS malignancy in
remission, without evidence of current/ prior brain metastasis, will also not
disqualify patient from participating.

- History of cardiac arrhythmia