An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection

The study is designed to obtain tumor samples from patients undergoing clinically indicated
surgical resection of a brain tumor or primary non-CNS tumor after infusion of 13C-glucose,
13C-acetate or 13C-glucose and 13C-acetate. Patients with a brain mass identified on brain
imaging and who need surgical resection of the mass will be eligible for this metabolism
study. Eligible study patients will be screened, recruited, and enrolled at UT Southwestern
Medical Center in the Harold C. Simmons Comprehensive Cancer Center, University Hospital -
Zale Lipshy and University Hospital - St. Paul, Children's Medical Center of Dallas as well
as at Parkland Health and Hospital System. We will consent 60 patients, including projected
screen failures and early withdrawals, and anticipate that we will study 25 patients in this
clinical protocol. Once enrolled, patients will undergo a series of preoperative brain
imaging studies including 3T MRI with Diffusion Tensor Imaging (DTI) and 1H-MR spectroscopy,
7T MRI and a brain 18FDG-PET scan within 7-14 days of the scheduled operation. Of these
studies, only the 3T MRI is standard of care. The DTI and 1H-MR spectroscopy are additional
scanning sequences that are being done for research purposes. Similarly, the 7T MRI and the
18FDG-PET are being done for research purposes only. On the day of surgery, the patient will
have a peripheral IV started while waiting in the preoperative holding area and a 20%
solution of either [U-13C]glucose and/or [1,2-13C]acetate (to be determined for each
individual patient by the PI) will be infused at a rate of 4g/hr for a maximum of 4 hours.
During the infusion period, 4 timed blood samples will be collected for NMR analysis of
13C-glucose in the blood. The infusion will continue until the tumor has been resected and
samples have been collected and flash frozen for 13C-NMR spectral analysis and molecular
analyses. The infusion and tumor collection for 13C-NMR analysis is being done for research
purposes only. However, the remainder of the neurosurgical operative and post-operative
procedures will be followed according to standard practice. The patient will be seen 10-14
days after surgery for a follow up visit at which time an assessment of adverse events will
be performed. Thereafter, every 6 months for 5 years or until death, the patient will be
contacted and data regarding treatment, responses, and tumor progression will be collected
for correlative analysis.

Inclusion Criteria:

- Male or female, any age and any racial or ethnic group

- Spanish-speaking patients will be eligible

- Pre-operative brain MR imaging suggestive of a brain tumor or pre-operative imaging
showing a tumor or biopsy of a tumor mass prior to planned resection of the mass

- Patient able and willing to provide informed consent or Legal parent or guardian
willing and able to provide informed consent for patient under age 18.

- Karnofsky Performance status > 70%

- Negative serum pregnancy test or child bearing potential terminated by surgery,
radiation, menopause or current use of two approved methods of birth control

Exclusion Criteria:

- Patient or legal parent/guardian unable to provide informed consent

- Karnofsky Performance status < 70%

- Patients who are claustrophobic or have other contraindications to MRI, such as
impanted pacemaker device vascular clips, surgical clips, prosthetic valves,
pacemakers, otologic implants

- NYHA class III and IV congestive heart failure

- Psychiatric or addictive disorders that preclude obtaining informed consent

- Unstable angina

- Pregnant or lactating women

- Women of childbearing potential who refuse a pregnancy test (performed during
screening)