Investigating brain tumor metabolism during surgery
An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection
This study is testing how brain tumors use sugar during surgery to help doctors better understand the tumors and find any hidden cancer cells.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT01668082 on ClinicalTrials.gov |
What this trial studies
This study aims to analyze the metabolic characteristics of brain tumors in patients undergoing surgical resection. By infusing a non-radioactive isotope of glucose (13C) during surgery, researchers will collect tumor samples and perform advanced imaging studies to correlate metabolic profiles with histopathological diagnoses. The study will involve preoperative imaging techniques, including 18FDG-PET and high-resolution MRI, to provide a comprehensive view of the tumor's metabolic activity. The goal is to identify infiltrative tumor cells and enhance understanding of tumor biology.
Who should consider this trial
Good fit: Ideal candidates are patients with newly identified brain masses requiring surgical resection.
Not a fit: Patients who are unable to provide informed consent or have contraindications to MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy and treatment strategies for patients with brain tumors.
How similar studies have performed: Other studies have shown promise in using metabolic profiling for tumor characterization, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Dallas, Texas
- University of Texas Southwestern — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Elizabeth Maher, MD, PhD — University of Texas
- Study coordinator: Elizabeth Maher, MD, PhD
- Phone: 214-648-7097
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.