Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT01668082

An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection

Led by University of Texas Southwestern Medical Center · Updated on 2025-05-14

40

Participants Needed

1

Research Sites

913 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, any age and any racial or ethnic group
  • Spanish-speaking patients are eligible
  • Pre-operative brain MRI or imaging showing a brain tumor or biopsy of a tumor mass before planned surgical removal
  • Patient able and willing to provide informed consent or legal guardian willing to consent for patients under 18
  • Karnofsky Performance status greater than 70%
  • Negative pregnancy test or childbearing potential ended by surgery, radiation, menopause, or use of two approved birth control methods
Not Eligible

You will not qualify if you...

  • Patient or legal guardian unable to provide informed consent
  • Karnofsky Performance status less than 70%
  • Claustrophobia or contraindications to MRI such as implanted pacemaker, vascular or surgical clips, prosthetic valves, or otologic implants
  • New York Heart Association class III or IV congestive heart failure
  • Psychiatric or addictive disorders preventing informed consent
  • Unstable angina
  • Pregnant or breastfeeding women
  • Women of childbearing potential who refuse pregnancy testing during screening

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Texas Southwestern

Dallas, Texas, United States, 75390

Actively Recruiting

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Research Team

E

Elizabeth Maher, MD, PhD

CONTACT

O

Omar Raslan, MBBCH,MPH, CCRP

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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