Recruiting

Observational Study

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT01668082

Conditions

Brain Mass

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

surgical resection of a brain tumor

Study Details

Brief summary:

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.

Conditions

Brain Mass

Study ID

NCT01668082

Start date

Aug, 2009

Status verified date

May, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 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.

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Interventions

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.

Primary outcome measure

  • metabolic phenotype correlation to clinical endpoints [ Time Frame: at end of follow-up period- between days 1-14 ]

Central Contacts and Locations

Central contacts

Elizabeth Maher, MD, PhD

214-648-7097

Omar Raslan, MBBCH,MPH, CCRP

214-648-7097omar.raslan@utsouthwestern.edu

Locations

University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75390

Contacts

Elizabeth Maher, MD, PhD

214-648-7097elizabeth.maher@utsouthwestern.edu

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

May 19, 2026

Last verified

May, 2026

Keywords

  • Patients with newly identified brain mass

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-05-19.