3T Perfluorocarbon-Filled Endorectal Magnetic Resonance Spectroscopic Imaging of Prostate
The goal of this clinical research study is to compare the technical quality of 2 ways of performing endorectal magnetic resonance spectroscopy imaging (MRSI) of the prostate, using a "3 Tesla (3T)" scanner. This is the first of a 2-part study. In Part 1, researchers will compare the use of perfluorocarbon compound (PFC) within the endorectal coil with the use of air in order to try to find out which technique may help to produce better-quality images. Researchers will also develop a "grading" system for diagnosing prostate cancer based on the changes in metabolic features at 3T scanners. The grading system will help researchers to label the prostate tissue (such as Grade 1, 2, or 3) in terms of whether or not there is a tumor and, if so, how aggressive the tumor is. In Part 2, the grading system will also be tested for its effectiveness in improving the detection of prostate tumors. The results of the experimental diagnostic grading system will be compared with the pathologist's results after the prostatectomy you will have as part of your standard of care.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||3T Perfluorocarbon-Filled Endorectal Magnetic Resonance Spectroscopic Imaging of Prostate|
- Comparison of linewidths collected from AIR MRSI and PFC-MSRI [ Time Frame: 2 MRSI studies should take about 60 minutes; study participation completed with prostatectomy to take place within 3 months of MRSI exams ] [ Designated as safety issue: No ]The outcome variable for comparing linewidths between the two modalities is paired differences of measurements taken from the same patients. A paired t-test is used to test for a 50% decrease in the mean linewidth as measured by PFC-MRSI versus AIR-MRSI.
|Study Start Date:||March 2007|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Experimental: 3T MRSI Prostate
3T Magnetic Resonance Spectroscopic Imaging
Procedure: 3T Magnetic Resonance Spectroscopic Imaging
Part 1 of Study = One MRSI exam with an air-filled endorectal coil (AIR-MRSI) and one with a PFC-filled endorectal coil (PFC-MRSI); Part 2 of Study = MRSI exam with PFC using an endorectal coil only.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00464724
|Contact: Haesun Choi, MD||713-745-4693|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Haesun Choi, MD|
|Principal Investigator:||Haesun Choi, MD||M.D. Anderson Cancer Center|