Brain Mass Clinical Trial
Official title:
An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | February 2027 |
Est. primary completion date | February 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Southwestern | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | baseline imaging data review | To compare and contrast baseline imaging data obtained on the 7T MR among the major brain tumor histological subtypes (e.g. low grade gliomas, glioblastoma, brain metastases) with emphasis on the differences in vascular integrity and extent of tumor infiltration for each subtype | at time of study entry- within 14 days of surgery | |
Secondary | molecular profiling | To correlate changes on 7T with the molecular profile of the primary resected tumor (molecular profiling is being done under a separate IRB approved protocol). | after surgical resection- day 0 |
Status | Clinical Trial | Phase | |
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