3T Perfluorocarbon-Filled Endorectal Magnetic Resonance Spectroscopic Imaging of Prostate
The objectives of this study are to: 1) evaluate the feasibility of 3T MRSI of prostate in improving the spectral resolution, using a PFC-filled endorectal coil, 2) develop a systematic metabolic grading system for tumor detection by identifying the abnormal peak areas of Cho, Cr, Po, and Ci for the prostate carcinoma, specifically from PFC-filled endorectal 3T MRSI, and 3) evaluate the efficacy of the metabolic grading system in tumor detection.
The long-term goal of the study is to provide an early prognostic indicator and means of monitoring the biologic status of the prostate cancer during the course of the disease.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (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 ]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.
|Actual Study Start Date:||March 2007|
|Estimated Study Completion Date:||March 2019|
|Estimated Primary Completion Date:||March 2019 (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|
|University of Texas 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|