An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection
Part of paid clinical trials in Dallas, Texas.
- Sponsor
- University of Texas Southwestern Medical Center
- Study ID
- NCT01668082
- Status
- Recruiting
Conditions
- Brain Mass
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- surgical resection of a brain tumor — PROCEDUREThe 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.
Study Details
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.
Key Dates
- Start date
- Aug 31, 2009
- Status verified
- May 2026
- Primary completion
- Feb 29, 2028
- Completion
- Feb 28, 2029
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: surgical resection of a brain tumorThe 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. \--------------------------------------------------------------------------------
Primary Outcome Measure
metabolic phenotype correlation to clinical endpoints [ Time Frame: at end of follow-up period- between days 1-14 ]
Central Contacts
- Elizabeth Maher, MD, PhD214-648-7097
- Omar Raslan, MBBCH,MPH, CCRP214-648-7097
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Texas Southwestern | Dallas | Texas | 75390 | Craig Malloy, MD (SUB_INVESTIGATOR) Changho Choi, PhD (SUB_INVESTIGATOR) Bruce Mickey, MD (SUB_INVESTIGATOR) Christopher Madden, MD (SUB_INVESTIGATOR) Robert Bachoo, MD, PhD (SUB_INVESTIGATOR) Ralph Deberardinis, MD, PhD (SUB_INVESTIGATOR) Juan Pascual, MD, PhD (SUB_INVESTIGATOR) Kimmo Hatanpaa, MD, PhD (SUB_INVESTIGATOR) Jack Raisanen, MD (SUB_INVESTIGATOR) Daniel Bowers, MD (SUB_INVESTIGATOR) Laura Klesse, MD, PhD (SUB_INVESTIGATOR) Bradley Weprin, MD (SUB_INVESTIGATOR) Kevin Courtney, MD, PhD (SUB_INVESTIGATOR) Patrick Leavey, MD (SUB_INVESTIGATOR) |