3T Perfluorocarbon-Filled Endorectal Magnetic Resonance Spectroscopic Imaging of Prostate

NCT ID: NCT00464724


Title
3T Perfluorocarbon-Filled Endorectal Magnetic Resonance Spectroscopic Imaging of Prostate
Purpose
Part 1: 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. Part 2: 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 second of a 2-part study. In Part 1, researchers compared the use of perfluorocarbon compound (PFC) within the endorectal coil with the use of air in order to try to find out which technique might help to produce better-quality images. And researchers have developed 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 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.
Details
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 "1.5T" 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 1.5T 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 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. This is an investigational study. The 3T scanners, software, and hardware used for this study are FDA-approved and being used in clinical practice. The use of air in the endorectal coil is a standard procedure. PFC has not yet been approved for use in endorectal MRSI exams. MRSI scans are commercially available and FDA-approved for routine clinical care. Up to 80 patients (40 in this part of the study and 40 in Part 2) will take part in this study. All will be enrolled at MD Anderson. 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 "1.5T" 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 1.5T 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 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. This is an investigational study. The 3T scanners, software, and hardware used for this study are FDA-approved and being used in clinical practice. PFC has not yet been approved for use in endorectal MRSI exams. MRSI scans are commercially available and FDA-approved for routine clinical care. Up to 80 patients (40 in this second part of the study and 40 in Part 1) will take part in this study. All will be enrolled at MD Anderson.
Conditions
Prostate Cancer
Keywords
Prostate Cancer, Magnetic Resonance Spectroscopic Imaging, Perfluorocarbon Compound, AIR-MRSI, PFC-MRSI, 3 Tesla, MRSI, PFC
Source
M.D. Anderson Cancer Center
Sponsors
M.D. Anderson Cancer Center, United States Department of Defense
Status
Recruiting
Acronym
Last Updated
09 Nov 2016
URL
Official Link
Locations
United States