RECRUITING

An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection

Quick Facts

Study Start:2009-08
Study Completion:2027-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01668082

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female, any age and any racial or ethnic group
  2. * Spanish-speaking patients will be eligible
  3. * 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
  4. * 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.
  5. * Karnofsky Performance status \> 70%
  6. * Negative serum pregnancy test or child bearing potential terminated by surgery, radiation, menopause or current use of two approved methods of birth control
  1. * Patient or legal parent/guardian unable to provide informed consent
  2. * Karnofsky Performance status \< 70%
  3. * Patients who are claustrophobic or have other contraindications to MRI, such as impanted pacemaker device vascular clips, surgical clips, prosthetic valves, pacemakers, otologic implants
  4. * NYHA class III and IV congestive heart failure
  5. * Psychiatric or addictive disorders that preclude obtaining informed consent
  6. * Unstable angina
  7. * Pregnant or lactating women
  8. * Women of childbearing potential who refuse a pregnancy test (performed during screening)

Contacts and Locations

Study Contact

Elizabeth Maher, MD, PhD
CONTACT
214-648-7097
Omar Raslan, MBBCH,MPH, CCRP
CONTACT
214-648-7097
omar.raslan@utsouthwestern.edu

Principal Investigator

Elizabeth Maher, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Texas

Study Locations (Sites)

University of Texas Southwestern
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Elizabeth Maher, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Texas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2009-08
Study Completion Date2027-02

Study Record Updates

Study Start Date2009-08
Study Completion Date2027-02

Terms related to this study

Keywords Provided by Researchers

  • Patients with newly identified brain mass

Additional Relevant MeSH Terms

  • Brain Mass