Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00464724
Status:
TERMINATED
Last Update Posted:
2020-02-10
First Post:
2007-04-23
Brief Title:
3T Perfluorocarbon-Filled Endorectal Magnetic Resonance Spectroscopic Imaging of Prostate
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
3T Perfluorocarbon-Filled Endorectal Magnetic Resonance Spectroscopic Imaging of Prostate
Status:
TERMINATED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objectives
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
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
Detailed Description:
Part 1
Prostate cancer tissue has certain differences in its metabolism chemical makeup that are not seen in normal tissue 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 body regions MRSI shows the metabolic features of the prostate cells MRSI exams that use a coil behind the prostate inside of the rectum have been used to measure the metabolic features of prostate cancer tissue This has been shown to improve the accuracy of finding prostate tumor using standard scanners called 15T scanners
The coil works like an antenna and air is normally used inside the coil to inflate it The accuracy of endorectal MRSI exams still needs improvement Use of PFC instead of air inside of the coil has been shown to greatly improve the quality of MRSI images at 15T scanners At first researchers want to learn if the newer stronger 3T scanners will improve the quality of endorectal MRSI exam when combined with PFC within the coil PFC is a clear and odorless liquid that as opposed to air is physically very similar to human tissue such as prostate tissue This makes the MRSI images much clearer
If you agree to take part in this study Part 1 and are found to be eligible you will have 2 MRSI exams one with air and one with PFC using an endorectal coil
Before being inserted the coil will be inflated with air to check for a possible leak You will lie on one side inside of a 3T MRI scanner and the coil covered with protective nonlatex or 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 exam can be completed Once the first MRSI exam is completed as much of the air as possible will be removed from the coil using a syringe
The coil will then be filled with PFC and the second MRSI exam will be repeated in the same manner At the end of the exam the PFC will be removed in the same manner and then the coil will be removed from the rectum There will be no direct contact between the PFC or air inside the coil and your body In total the 2 MRSI studies should take about 60 minutes
You will have a prostatectomy surgical removal of the prostate within 3 months of having the MRSI exams performed After the operation your participation in this study will be over
Part 2
Prostate cancer tissue has certain differences in its metabolism chemical makeup that are not seen in normal tissue 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 shows the metabolic features of the prostate MRSI exams that use a coil behind the prostate inside of the rectum have been used to measure the metabolic features of prostate cancer tissue This has been shown to improve the accuracy of prostate tumor detection at standard scanners called 15T scanners
The coil works like an antenna and air is normally used inside the coil to inflate it The accuracy of endorectal MRSI exams still needs improvement Use of PFC instead of air inside of the coil has been shown to greatly improve the quality of MRSI images at 15T scanners At first researchers want to learn if the newer stronger 3T scanners will improve the quality of endorectal MRSI exam when combined with PFC within the coil PFC is a clear and odorless liquid that as opposed to air is physically very similar to human tissue such as prostate tissue This makes the MRSI images much clearer
If you agree to take part in this study Part 2 and are found to be eligible you will have an MRSI exam with PFC using an endorectal coil Only PFC will be used
Before being inserted the coil will be inflated with air to check for a possible leak and as much as possible of the air will be removed You will lie on one side inside of a 3T MRI scanner and the coil covered with protective nonlatex or 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 PFC and you will lie on your back so the MRSI exam can be completed Once the exam is completed the PFC will be removed from the coil using a syringe and then the coil will be removed from the rectum There will be no direct contact between the PFC inside the coil and your body The procedure should take about 30 minutes
You will have a prostatectomy surgical removal of the prostate within 3 months of having the MRSI exam performed After the operation your participation in this study will be over
Prostate cancer tissue has certain differences in its metabolism chemical makeup that are not seen in normal tissue 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 body regions MRSI shows the metabolic features of the prostate cells MRSI exams that use a coil behind the prostate inside of the rectum have been used to measure the metabolic features of prostate cancer tissue This has been shown to improve the accuracy of finding prostate tumor using standard scanners called 15T scanners
The coil works like an antenna and air is normally used inside the coil to inflate it The accuracy of endorectal MRSI exams still needs improvement Use of PFC instead of air inside of the coil has been shown to greatly improve the quality of MRSI images at 15T scanners At first researchers want to learn if the newer stronger 3T scanners will improve the quality of endorectal MRSI exam when combined with PFC within the coil PFC is a clear and odorless liquid that as opposed to air is physically very similar to human tissue such as prostate tissue This makes the MRSI images much clearer
If you agree to take part in this study Part 1 and are found to be eligible you will have 2 MRSI exams one with air and one with PFC using an endorectal coil
Before being inserted the coil will be inflated with air to check for a possible leak You will lie on one side inside of a 3T MRI scanner and the coil covered with protective nonlatex or 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 exam can be completed Once the first MRSI exam is completed as much of the air as possible will be removed from the coil using a syringe
The coil will then be filled with PFC and the second MRSI exam will be repeated in the same manner At the end of the exam the PFC will be removed in the same manner and then the coil will be removed from the rectum There will be no direct contact between the PFC or air inside the coil and your body In total the 2 MRSI studies should take about 60 minutes
You will have a prostatectomy surgical removal of the prostate within 3 months of having the MRSI exams performed After the operation your participation in this study will be over
Part 2
Prostate cancer tissue has certain differences in its metabolism chemical makeup that are not seen in normal tissue 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 shows the metabolic features of the prostate MRSI exams that use a coil behind the prostate inside of the rectum have been used to measure the metabolic features of prostate cancer tissue This has been shown to improve the accuracy of prostate tumor detection at standard scanners called 15T scanners
The coil works like an antenna and air is normally used inside the coil to inflate it The accuracy of endorectal MRSI exams still needs improvement Use of PFC instead of air inside of the coil has been shown to greatly improve the quality of MRSI images at 15T scanners At first researchers want to learn if the newer stronger 3T scanners will improve the quality of endorectal MRSI exam when combined with PFC within the coil PFC is a clear and odorless liquid that as opposed to air is physically very similar to human tissue such as prostate tissue This makes the MRSI images much clearer
If you agree to take part in this study Part 2 and are found to be eligible you will have an MRSI exam with PFC using an endorectal coil Only PFC will be used
Before being inserted the coil will be inflated with air to check for a possible leak and as much as possible of the air will be removed You will lie on one side inside of a 3T MRI scanner and the coil covered with protective nonlatex or 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 PFC and you will lie on your back so the MRSI exam can be completed Once the exam is completed the PFC will be removed from the coil using a syringe and then the coil will be removed from the rectum There will be no direct contact between the PFC inside the coil and your body The procedure should take about 30 minutes
You will have a prostatectomy surgical removal of the prostate within 3 months of having the MRSI exam performed After the operation your participation in this study will be over
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PC061612 | OTHER | DOD | None |
| NCI-2011-00517 | REGISTRY | None | None |