Prostate CancerNCT00464724
3T Perfluorocarbon-Filled Endorectal Magnetic Resonance Spectroscopic Imaging of Prostate
A study testing 3T Magnetic Resonance Spectroscopic Imaging in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 3T Magnetic Resonance Spectroscopic Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to 12 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven, clinical stage 1-3 prostate carcinomas
- Prostatectomy at M. D. Anderson within 3 months from the time of MRSI
- An interval of > 6 weeks between the biopsy and MRSI
- Signed informed consent form
Who cannot join
- Contraindications for MRI (e.g. cardiac pacemaker)
- Contraindications for MRS (e.g. history of abdomino-perineal resection of rectum)
- Metals or any conditions (e.g. hip prosthesis) that can distort the local magnetic field
- Previous prostate surgery for prostate carcinoma (including, TURP and cryosurgery), local or systemic treatment for prostate carcinoma (e.g. radiation, androgen deprivation), pelvic radiation (e.g. rectal cancer), rectal surgery, BCG for bladder cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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.
Read the 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 "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 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 "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 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.
- Conditions
- Prostate Cancer
- Being tested
- 3T Magnetic Resonance Spectroscopic Imaging
- Keywords
- Prostate Cancer, Magnetic Resonance Spectroscopic Imaging, Perfluorocarbon Compound, AIR-MRSI, PFC-MRSI, 3 Tesla, MRSI, PFC
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3T Magnetic Resonance Spectroscopic ImagingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 3T MRSI Prostate | Experimental | 3T Magnetic Resonance Spectroscopic Imaging Receives: Procedure: 3T Magnetic Resonance Spectroscopic Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of linewidths collected from AIR MRSI and PFC-MSRI
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.
Measured: 2 MRSI studies should take about 60 minutes; study participation completed with prostatectomy to take place within 3 months of MRSI exams
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2007 (estimated)
- Study startMar 2007
- Primary completion12 Dec 2019
- Study completion12 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, GE Healthcare
- Responsible party
- Sponsor
- Investigators
- Haesun Choi, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00464724
- Sponsor's protocol ID
- 2006-0516
- Other IDs
- NCI-2011-00517, PC061612
- Status last verified
- Feb 2020
- First submitted
- 23 Apr 2007
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3T Perfluorocarbon-Filled Endorectal Magnetic Resonance Spectroscopic Imaging of Prostate
- ClinicalTrials.gov ID
- NCT00464724
- Acronym / sponsor ID
- 2006-0516
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Magnetic Resonance Spectroscopic Imaging, Perfluorocarbon Compound, AIR-MRSI, PFC-MRSI, 3 Tesla, MRSI, PFC
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 90 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense, GE Healthcare
- Study start
- Mar 2007 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 24 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 "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 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 "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 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3T MRSI Prostate | Experimental | Procedure: 3T Magnetic Resonance Spectroscopic Imaging3T Magnetic Resonance Spectroscopic Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Biopsy proven, clinical stage 1-3 prostate carcinomas
- Prostatectomy at M. D. Anderson within 3 months from the time of MRSI
- An interval of > 6 weeks between the biopsy and MRSI
- Signed informed consent form
Key exclusion criteria (4 listed)
- Contraindications for MRI (e.g. cardiac pacemaker)
- Contraindications for MRS (e.g. history of abdomino-perineal resection of rectum)
- Metals or any conditions (e.g. hip prosthesis) that can distort the local magnetic field
- Previous prostate surgery for prostate carcinoma (including, TURP and cryosurgery), local or systemic treatment for prostate carcinoma (e.g. radiation, androgen deprivation), pelvic radiation (e.g. rectal cancer), rectal surgery, BCG for bladder cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3T Magnetic Resonance Spectroscopic ImagingPart 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. | Procedure or surgery | 3T MRSI Prostate |
Primary outcome
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.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haesun Choi, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3T Magnetic Resonance Spectroscopic Imaging in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.