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NCT01668082 · ClinicalTrials.gov registry record · NA
An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection
A NA study of Brain Mass, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT01668082 is a NA study of Brain Mass that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 40 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01668082, a NA study of Brain Mass, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- PROCEDURE surgical resection of a brain tumor
Study Locations (1)
Texas
- University of Texas Southwestern - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2009-08 |
| Est. Completion | 2027-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01668082
The ClinicalTrials.gov registry entry for NCT01668082 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Brain Mass appearing as the primary indexed condition, and to 1 intervention - of which surgical resection of a brain tumor is the first listed.
NCT01668082 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT01668082 about?
NCT01668082 is a clinical study titled "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,...
What is the current status of trial NCT01668082?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2009-08. Estimated completion is 2027-02.
What conditions does trial NCT01668082 study?
This clinical trial studies the following conditions: Brain Mass.
What interventions are being tested in trial NCT01668082?
The interventions under investigation include: surgical resection of a brain tumor (PROCEDURE).
Who is sponsoring clinical trial NCT01668082?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01668082 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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