Clinical Trial Finder

Inclusion Criteria:

• - Written informed consent will be obtained from each participants including healthy volunteers.

• - Healthy volunteers will not have contra-indications to MR scanning, but will otherwise not be subject to other selection criteria.

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

• - Patient is >18 years old, 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 we hope to recruit. To reduce heterogeneity in the patient population we 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 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:

• - Healthy volunteers will be screened using same process but will otherwise not be subject to other selection 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 (> 6month) of non-CNS malignancy in remission, without evidence of current/ prior brain metastasis, will also not disqualify patient from participating. - History of cardiac arrhythmia

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.

Arms

Experimental: Diagnostic (carbon C 13 pyruvate, MRSI)

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

Interventions

Drug: - Hyperpolarized Carbon C 13 Pyruvate

Given IV

Procedure: - Magnetic Resonance Spectroscopic Imaging

Undergo MRSI