Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00429338
Status:
TERMINATED
Last Update Posted:
2015-01-09
First Post:
2007-01-29
Brief Title:
3T Endorectal Magnetic Resonance Spectroscopic Imaging MRSI of Prostate
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Feasibility Study of 3T Endorectal Magnetic Resonance Spectroscopic Imaging MRSI of Prostate
Status:
TERMINATED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow Accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to evaluate the feasibility of 3T magnetic resonance spectroscopic imaging MRSI of the prostate in improving the spectral resolution using a perfluorocarbon compound PFC-filled endorectal coil
Specific Aim 1 To compare the spectral quality measured in Hz linewidth of 3T MRSI performed with an air-filled endorectal coil AIR-MRSI and a PFC-filled endorectal coil PFC-MRSI
Specific Aim 2 To compare the quality of spectra of PFC-MRSI by grading the overall quality of MRSI data of each patient subjectively as being excellent good fair poor and non-diagnostic based on the status of subjective spectral resolution of Cho Cr and Po peaks signal to noise ratio SNR baseline distortion and fat contamination
Specific Aim 1 To compare the spectral quality measured in Hz linewidth of 3T MRSI performed with an air-filled endorectal coil AIR-MRSI and a PFC-filled endorectal coil PFC-MRSI
Specific Aim 2 To compare the quality of spectra of PFC-MRSI by grading the overall quality of MRSI data of each patient subjectively as being excellent good fair poor and non-diagnostic based on the status of subjective spectral resolution of Cho Cr and Po peaks signal to noise ratio SNR baseline distortion and fat contamination
Detailed Description:
MRSI is a type of magnetic resonance imaging MRI that uses the same type of scanner as a standard MRI Unlike standard MRI which takes pictures of the anatomy body regions MRSI takes pictures of the metabolic features of the body Prostate cancer tissue has certain differences in its metabolism chemical makeup that are not seen in normal tissue MRSI is used to detect prostate tumors by measuring the metabolic features and an endorectal inside of the rectum coil is used The coil is like an antenna
Endorectal coils inflated with air are commonly used to detect prostate tumors and measure the status of the disease using a 15T lower-powered standard clinical scanner However the accuracy of endorectal MRSI scanning still needs improvement Researchers want to find out if the quality of endorectal MRSI scanning can be improved by using a stronger 3T scanner andor using PFC in the endorectal coil instead of air PFC is a clear and odorless liquid that is known to be virtually non-toxic to the human body It has been used as an oral contrast swallowed by mouth for standard MRIs As opposed to air PFC is physically very similar to prostate tissue which may improve the quality of the MRSI images
If you agree to take part in this study you will have 2 endorectal MRSI studies one with air and one with PFC The MRSI study with air is diagnostic and considered standard of care and the MRSI study with PFC is investigational Before being inserted into your rectum the coil will be filled with air in order to test for any leakage You will lie on one side inside of a 3T MRI scanner and the coil covered with protective latex will be inserted into your rectum Having the coil inserted is similar to having an enema tip inserted The coil will be filled with air and you will lie on your back so the first MRSI study can be completed The study doctor will carefully check the coil to be sure it is centered at the right place to cover the entire prostate
After the first MRSI study is completed the air will be removed using a syringe The coil will then be filled with PFC and the second MRSI study will be repeated in the same manner Once both studies are completed the coil will be removed after the PFC is removed from the coil There will be no direct contact between the air or PFC within the coil and your body In total the 2 MRSI studies should take about 60 minutes
After the MRSI studies are completed researchers will study the information with a special computer to compare the technical quality of the 2 sets of MRSIs Your participation in this study will be over Your doctor will receive a report of your diagnostic exam the MRSI study with air
This is an investigational study 3T scanners and the software for routine MRI used for this study are FDA-approved The use of air in the endorectal coil is a standard procedure MRSIMRI equipment for a 15T scanner is commercially available and FDA-approved for routine clinical care PFC used for this study and the software for MRSI acquisition at a 3T scanner have not been FDA-approved Up to 20 patients will take part in this study All will be enrolled at M D Anderson
Endorectal coils inflated with air are commonly used to detect prostate tumors and measure the status of the disease using a 15T lower-powered standard clinical scanner However the accuracy of endorectal MRSI scanning still needs improvement Researchers want to find out if the quality of endorectal MRSI scanning can be improved by using a stronger 3T scanner andor using PFC in the endorectal coil instead of air PFC is a clear and odorless liquid that is known to be virtually non-toxic to the human body It has been used as an oral contrast swallowed by mouth for standard MRIs As opposed to air PFC is physically very similar to prostate tissue which may improve the quality of the MRSI images
If you agree to take part in this study you will have 2 endorectal MRSI studies one with air and one with PFC The MRSI study with air is diagnostic and considered standard of care and the MRSI study with PFC is investigational Before being inserted into your rectum the coil will be filled with air in order to test for any leakage You will lie on one side inside of a 3T MRI scanner and the coil covered with protective latex will be inserted into your rectum Having the coil inserted is similar to having an enema tip inserted The coil will be filled with air and you will lie on your back so the first MRSI study can be completed The study doctor will carefully check the coil to be sure it is centered at the right place to cover the entire prostate
After the first MRSI study is completed the air will be removed using a syringe The coil will then be filled with PFC and the second MRSI study will be repeated in the same manner Once both studies are completed the coil will be removed after the PFC is removed from the coil There will be no direct contact between the air or PFC within the coil and your body In total the 2 MRSI studies should take about 60 minutes
After the MRSI studies are completed researchers will study the information with a special computer to compare the technical quality of the 2 sets of MRSIs Your participation in this study will be over Your doctor will receive a report of your diagnostic exam the MRSI study with air
This is an investigational study 3T scanners and the software for routine MRI used for this study are FDA-approved The use of air in the endorectal coil is a standard procedure MRSIMRI equipment for a 15T scanner is commercially available and FDA-approved for routine clinical care PFC used for this study and the software for MRSI acquisition at a 3T scanner have not been FDA-approved Up to 20 patients will take part in this study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None