An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection

NCT01668082 | Recruiting DMC

• 1 other identifier: STU 062010-157
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Patients with newly identified brain mass

Outcome Measures

Primary Outcomes (1)

• metabolic phenotype correlation to clinical endpoints

  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

  at end of follow-up period- between days 1-14

Secondary Outcomes (2)

• baseline imaging data review

  at time of study entry- within 14 days of surgery

• molecular profiling

  after surgical resection- day 0

Study Arms (1)

surgical resection of a brain tumor

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. \--------------------------------------------------------------------------------

Procedure: surgical resection of a brain tumor

Interventions

surgical resection of a brain tumor PROCEDURE

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.

surgical resection of a brain tumor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern

Dallas, Texas, 75390, United States

RECRUITING

Study Officials

• Elizabeth Maher, MD, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Maher, MD, PhD

CONTACT

214-648-7097

Omar Raslan, MBBCH,MPH, CCRP

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: August 17, 2012
• Study Start: August 1, 2009
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)