NCT01668082 An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection
| NCT ID | NCT01668082 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Brain Mass |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2009-08 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2009-08 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Elizabeth Maher, MD, PhD
📞 214-648-7097
Elizabeth Maher, MD, PhD
PRINCIPAL INVESTIGATOR
University of Texas
Frequently Asked Questions
Who can join the NCT01668082 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Mass. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01668082 currently recruiting?
Yes, NCT01668082 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Texas Southwestern Medical Center to inquire about joining.
Where is the NCT01668082 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT01668082 clinical trial?
NCT01668082 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Elizabeth Maher, MD, PhD at University of Texas. The trial plans to enroll 40 participants.