RECRUITINGINTERVENTIONAL

An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection

About This Trial

The study is designed to use infusion of a non-radioactive, naturally occurring isotope of glucose (13C) in patients undergoing surgical resection for a newly identified brain mass to obtain the metabolic phenotype of the tumor, and correlate it with the histopathological diagnosis. In each patient, 13C NMR spectral analysis of tumor extracts will be obtained after intraoperative infusion of \[U-13C\]glucose or \[1,2-13C\]glucose. Whenever feasible, patients will undergo 3 preoperative imaging studies - 18FDG-PET, diffusion tensor imaging with 1H-spectroscopy on 3T MR scanner, and ultra high resolution MR imaging on the 7T MR scanner. The results of these imaging studies will be correlated with the metabolic phenotype to generate a comprehensive non-invasive view of the tumor with the goal of identifying infiltrative, metabolically active tumor cells within the brain. In addition, a comprehensive molecular profile of the tumor will be obtained and enable a genotype-metabolic phenotype comparative analysis. Correlative Translational Research The investigators will obtain tumor tissue from each patient for comprehensive molecular analysis (array CGH, expression profiling, methylation profiling) which will be correlated with tumor histology, the metabolites identified by 1H-MR spectroscopy and the 13Cglucose metabolic profile. Patients will be followed at designated time points along their treatment course to obtain information about ongoing treatment and response, time to tumor progression and overall survival. These parameters will be used in correlational analysis with the metabolic phenotype.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form or Legal parent or guardian willing and able to provide willing to sign a consent form 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 Who Should NOT Join This Trial: - Patient or legal parent/guardian unable to provide willing to sign a consent form - 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 willing to sign a consent form - Unstable angina - Pregnant or lactating women - Women of childbearing potential who refuse a pregnancy test (performed during screening) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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)

Treatments Being Tested

PROCEDURE

surgical resection of a brain tumor

The patient will undergo surgical removal of the tumor after infusion of 13C-glucose using standard neurosurgical technique, including frameless stereotaxy for surgical navigation, and microsurgical technique.

Locations (1)

University of Texas Southwestern

Dallas, Texas, United States