Prostate CancerNCT00429338
3T Endorectal Magnetic Resonance Spectroscopic Imaging (MRSI) of Prostate
A study testing AIR-MRSI and PFC-MRSI in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. 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?
- AIR-MRSI and PFC-MRSI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Oct 2013
- 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
- Newly diagnosed biopsy proven prostate carcinoma who are referred to Diagnostic Imaging for magnetic resonance imaging (MRI) / magnetic resonance spectroscopic imaging (MRSI)
- No previous radiation to prostate or pelvis
- No hormonal treatment for prostate
- The interval between the biopsy and magnetic resonance spectroscopic imaging (MRSI): more than 6 weeks
- Informed consent
Who cannot join
- Contraindications for MRI (e.g. cardiac pacemaker)
- Allergy to Latex
- Contraindications for magnetic resonance spectroscopic imaging (MRSI) (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, 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, BCG for bladder cancer
- Children (<18 years)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of 3T Endorectal Magnetic Resonance Spectroscopic Imaging (MRSI) of Prostate
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.
Read the 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 1.5T (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 and/or 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. MRSI/MRI equipment for a 1.5T 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.
- Conditions
- Prostate Cancer
- Being tested
- AIR-MRSI, PFC-MRSI
- Keywords
- Genitourinary, Prostate Cancer, Magnetic Resonance Imaging, MRI, Magnetic Resonance Spectroscopic Imaging, MRSI, Endorectal MRSI, Endorectal magnetic resonance spectroscopy imaging, 3 Tesla, 3T Scan, Endorectal coil, Perfluorocarbon compound, PFC, PFC-filled endorectal coil, PFC-MRSI, AIR-MRSI
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIR-MRSIProcedure or surgery
Also called Endorectal magnetic resonance spectroscopy imaging, Magnetic resonance imaging, MRI
3T Magnetic Resonance Spectroscopic Imaging (MSRI) scan performed with an air-filled endorectal coil (AIR-MRSI).
PFC-MRSIProcedure or surgery
Also called Endorectal magnetic resonance spectroscopy imaging, Magnetic resonance imaging, MRI
3T Magnetic Resonance Spectroscopic Imaging (MSRI) scan performed with a perfluorocarbon compound (PFC)-filled endorectal coil (PFC-MRSI).
| Study group | Role | What they receive |
|---|---|---|
| AIR-MRSI | Experimental | Endorectal MRSI with Air Receives: Procedure: AIR-MRSI |
| PFC-MRSI | Experimental | Endorectal MRSI with PFC Receives: Procedure: PFC-MRSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spectral quality (linewidth) of 3T MRSI performed with air-filled endorectal coil (AIR-MRSI) and a PFC-filled endorectal coil (PFC-MRSI)
Comparison of each linewidths (measured in Hz) between two modalities: endorectal magnetic resonance spectroscopy imaging (MRSI) of prostate using "3 Tesla (3T)" scanner with 1) perfluorocarbon compound (PFC) within endorectal coil versus 2) air.
Measured: 60 Minutes for 2 sets of MRIs
Secondary outcomes (1)
Total number of patients for each grade from each group with AIR-MRSI and PFC-MRSI
The quality of PFC-MRSI and AIR-MRSI will be graded subjectively as being "excellent," "good," "fair," "poor," and "non-diagnostic," based on the status of subjective spectral resolution of Cho, Cr, Po, and Ci peaks, signal-noise-ratio (SNR), baseline distortion, and fat and seminal vesicle contaminations.
Measured: Patients: 60 Minutes for 2 sets of MRIs; Study Duration 4 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionOct 2013
- Study completionOct 2013
Why it stopped: Slow Accrual
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haesun Choi, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429338
- Sponsor's protocol ID
- 2006-0333
- Status last verified
- Jan 2015
- First submitted
- 29 Jan 2007
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of 3T Endorectal Magnetic Resonance Spectroscopic Imaging (MRSI) of Prostate
- ClinicalTrials.gov ID
- NCT00429338
- Acronym / sponsor ID
- 2006-0333
- Conditions
- Prostate Cancer
- Keywords
- Genitourinary, Prostate Cancer, Magnetic Resonance Imaging, MRI, Magnetic Resonance Spectroscopic Imaging, MRSI, Endorectal MRSI, Endorectal magnetic resonance spectroscopy imaging
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 8 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 31 Jan 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.
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.
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 1.5T (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 and/or 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. MRSI/MRI equipment for a 1.5T 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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIR-MRSI | Experimental | Procedure: AIR-MRSIEndorectal MRSI with Air |
| PFC-MRSI | Experimental | Procedure: PFC-MRSIEndorectal MRSI with PFC |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Newly diagnosed biopsy proven prostate carcinoma who are referred to Diagnostic Imaging for magnetic resonance imaging (MRI) / magnetic resonance spectroscopic imaging (MRSI)
- No previous radiation to prostate or pelvis
- No hormonal treatment for prostate
- The interval between the biopsy and magnetic resonance spectroscopic imaging (MRSI): more than 6 weeks
- Informed consent
Key exclusion criteria (6 listed)
- Contraindications for MRI (e.g. cardiac pacemaker)
- Allergy to Latex
- Contraindications for magnetic resonance spectroscopic imaging (MRSI) (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, 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, 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 |
|---|---|---|
| AIR-MRSIAlso: Endorectal magnetic resonance spectroscopy imaging, Magnetic resonance imaging, MRI3T Magnetic Resonance Spectroscopic Imaging (MSRI) scan performed with an air-filled endorectal coil (AIR-MRSI). | Procedure or surgery | AIR-MRSI |
| PFC-MRSIAlso: Endorectal magnetic resonance spectroscopy imaging, Magnetic resonance imaging, MRI3T Magnetic Resonance Spectroscopic Imaging (MSRI) scan performed with a perfluorocarbon compound (PFC)-filled endorectal coil (PFC-MRSI). | Procedure or surgery | PFC-MRSI |
Primary outcome
Spectral quality (linewidth) of 3T MRSI performed with air-filled endorectal coil (AIR-MRSI) and a PFC-filled endorectal coil (PFC-MRSI)
Time frame: 60 Minutes for 2 sets of MRIs
Comparison of each linewidths (measured in Hz) between two modalities: endorectal magnetic resonance spectroscopy imaging (MRSI) of prostate using "3 Tesla (3T)" scanner with 1) perfluorocarbon compound (PFC) within endorectal coil versus 2) air.
1 secondary outcome
Total number of patients for each grade from each group with AIR-MRSI and PFC-MRSI
Time frame: Patients: 60 Minutes for 2 sets of MRIs; Study Duration 4 Years
Results and safety
The study was stopped early (reason given: Slow Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2015.
- UT 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 AIR-MRSI and PFC-MRSI 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 5 inclusion and 6 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 9 Jan 2015. 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 (reason given: Slow Accrual). 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?
Spectral quality (linewidth) of 3T MRSI performed with air-filled endorectal coil (AIR-MRSI) and a PFC-filled endorectal coil (PFC-MRSI) (time frame: 60 Minutes for 2 sets of MRIs). 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 9 Jan 2015.