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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00464724
First received: April 23, 2007
Last updated: September 26, 2014
Last verified: September 2014

April 23, 2007
September 26, 2014
March 2007
March 2016   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT00464724 on ClinicalTrials.gov Archive Site
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3T Perfluorocarbon-Filled Endorectal Magnetic Resonance Spectroscopic Imaging of Prostate
3T Perfluorocarbon-Filled Endorectal Magnetic Resonance Spectroscopic Imaging of Prostate

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Prostate Cancer
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.
Experimental: 3T MRSI Prostate
3T Magnetic Resonance Spectroscopic Imaging
Intervention: Procedure: 3T Magnetic Resonance Spectroscopic Imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
Not Provided
March 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Biopsy proven, clinical stage 1-3 prostate carcinomas
  2. Prostatectomy at M. D. Anderson within 3 months from the time of MRSI
  3. An interval of > 6 weeks between the biopsy and MRSI
  4. Signed informed consent form

Exclusion Criteria:

  1. Contraindications for MRI (e.g. cardiac pacemaker)
  2. Allergy to Latex
  3. Contraindications for MRS (e.g. history of abdomino-perineal resection of rectum)
  4. Metals or any conditions (e.g. hip prosthesis) that can distort the local magnetic field
  5. Previous prostate surgery for prostate carcinoma (including, Transurethral resection of the prostate (TURP) and cryosurgery), local or systemic treatment for prostate carcinoma (e.g. radiation, androgen deprivation), pelvic radiation (e.g. rectal cancer), rectal surgery, Bacillus Calmette-Guerin (BCG) for bladder cancer
Male
18 Years and older
No
Contact: Haesun Choi, MD 713-745-4693
United States
 
NCT00464724
2006-0516, NCI-2011-00517, PC061612
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Department of Defense
Principal Investigator: Haesun Choi, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP