3T Perfluorocarbon-Filled Endorectal Magnetic Resonance Spectroscopic Imaging of Prostate
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|ClinicalTrials.gov Identifier: NCT00464724|
Recruitment Status : Terminated
First Posted : April 24, 2007
Last Update Posted : February 10, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Procedure: 3T Magnetic Resonance Spectroscopic Imaging||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||3T Perfluorocarbon-Filled Endorectal Magnetic Resonance Spectroscopic Imaging of Prostate|
|Actual Study Start Date :||March 2007|
|Actual Primary Completion Date :||December 12, 2019|
|Actual Study Completion Date :||December 12, 2019|
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00464724
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Haesun Choi, MD||M.D. Anderson Cancer Center|