This pilot trial studies carbon-13 nuclear magnetic resonance (13C NMR) in metabolic analysis of patients with brain tumors undergoing surgical resection. New diagnostic procedures, such as 13C-NMR, may help doctors study the side effects of cancer therapy in patients undergoing surgery for brain tumors.
Additional locations may be listed on ClinicalTrials.gov for NCT01668082.
Locations matching your search criteria
United States
Texas
Dallas
UT Southwestern/Simmons Cancer Center-DallasStatus: Active
Contact: Elizabeth Anne Maher
Phone: 214-645-5905
PRIMARY OBJECTIVES:
I. To generate a 13C NMR spectra from tumor tissue removed at the time of surgical resection and identify the active metabolic pathways in each tumor, thus determining its metabolic phenotype.
II. To correlate the metabolic phenotype with the results from histopathological diagnosis and pre-operative fludeoxyglucose F18 (18FDG)-positron emission tomography (PET) imaging.
III. To correlate the metabolic phenotype obtained from histopathological diagnosis with the clinical endpoints of time to tumor progression and overall survival during the 5 years of patient follow-up.
SECONDARY OBJECTIVES:
I. To obtain non-invasive metabolic imaging data by pre-operative proton magnetic resonance (1H-MR) spectroscopy and correlate the metabolic profile with the 13C NMR spectra.
II. To compare and contrast baseline imaging data obtained on the 7-tesla magnetic resonance (7T MR) among the major brain tumor histological subtypes (e.g. low grade gliomas, glioblastoma, brain metastases) with emphasis on the differences in vascular integrity and extent of tumor infiltration for each subtype.
III. To correlate changes on 7T with the molecular profile of the primary resected tumor (molecular profiling is being done under a separate institutional review board [IRB] approved protocol).
IV. To compare the 13C-NMR spectra and metabolic phenotype of primary, non-central nervous system (CNS) tumors, with brain metastases of the same tumor type and molecular profile.
V. To evaluate metabolomic profiles in extra-cranial solid tumors.
OUTLINE:
Patients receive intra-operative infusion of uniformly-labeled [U-13C] glucose; 1,2-carbon C 13-labeled glucose; 1, 2-13C acetate; or combined uniformly-labeled [U-13C] glucose and 2-13C acetate. Samples are then analyzed via 13C NMR.
After completion of study treatment, patients are followed up every 6 months for up to 5 years.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationUT Southwestern/Simmons Cancer Center-Dallas
Principal InvestigatorElizabeth Anne Maher