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Brain Tumor Metabolism Investigation Using 13C-Glucose and 13C-Acetate in Patients Undergoing Surgical Resection

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Study Aim

This study aims to correlate the metabolic phenotype obtained from histopathological diagnosis with the clinical endpoints of time to tumor progression and overall survival in patients undergoing surgical resection for brain tumors, during a 5-year follow-up period.

What is being tested

surgical resection of a brain tumor

Procedure
Who is being recruted

Over 18 Years
+14 Eligibility Criteria
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How is the trial designed

Diagnostic Study

Interventional
Study Start: August 2009
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Summary

Principal SponsorUniversity of Texas Southwestern Medical Center
Study ContactElizabeth Maher, MD, PhDMore contacts
Last updated: May 19, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2009

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversity of Texas Southwestern Medical Center
Study ContactElizabeth Maher, MD, PhDMore contacts
Last updated: May 19, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

6 inclusion criteria required to participate
Karnofsky Performance status > 70%

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

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

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

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8 exclusion criteria prevent from participating
Karnofsky Performance status < 70%

NYHA class III and IV congestive heart failure

Patient or legal parent/guardian unable to provide informed consent

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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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. \--------------------------------------------------------------------------------

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

University of Texas Southwestern

Dallas, United StatesOpen University of Texas Southwestern in Google Maps
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One Study Center