Prostate CancerNCT00588679
Magnetic Resonance Spectroscopic Imaging of the Prostate at 3 Tesla
A study testing Magnetic Resonance Imaging; Spectroscopic Imaging, Contrast Enhanced Imaging in people with Prostate Cancer and MRI, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the benefits of Magnetic Resonance Imaging (MRI) combined with Magnetic Resonance Spectroscopic Imaging (MRSI), on an instrument called a 3.0 Tesla (T) MR scanner. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostate Cancer, MRI
- What is being tested?
- Magnetic Resonance Imaging; Spectroscopic Imaging, Contrast Enhanced Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2006to 6 Mar 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 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have clinically suspected or biopsy proven prostate cancer. If a patient has been diagnosed with prostate cancer an official report of biopsy from MSKCC or outside site is required. All outside pathology reports will be confirmed at MSKCC.
- For those patients who have undergone prostate biopsy it is recommended that the interval between biopsy and protocol MRI/MRSI should be at least 8 weeks.
- Patient is a potential surgical candidate for treatment of prostate cancer
- Patient is willing to undergo an endorectal MRI/MRSI exam on the 3.0T MR scanner
Who cannot join
- Patients who because of general medical or psychiatric condition, or physiologic status unrelated to the presence of prostate cancer cannot give valid informed consent.
- Patients who are unwilling or unable to undergo MRI/MRSI (including patients with contra-indications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips.
- Patients who cannot tolerate or have contra-indications to endorectal coil insertion; for example, patients who have had a prior abdominoperineal resection of the rectum or have Crohn's disease, patients with severe hemorrhoids, patients who have had prior radiation to the pelvis to treat a malignancy, or patients who have had minor rectal surgery within the previous 8 weeks.
- Patients with an allergic reaction to latex.
- Patients with a metallic hip implant or any other metallic implant or device in the pelvis that might distort local magnetic field and compromise quality of MRI/MRSI.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to determine the benefits of Magnetic Resonance Imaging (MRI) combined with Magnetic Resonance Spectroscopic Imaging (MRSI), on an instrument called a 3.0 Tesla (T) MR scanner.
- Conditions
- Prostate Cancer, MRI
- Being tested
- Magnetic Resonance Imaging; Spectroscopic Imaging, Contrast Enhanced Imaging
- Keywords
- Prostate Cancer, Cancer, MRI, Magnetic Resonance Imaging, 06-035
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging; Spectroscopic Imaging, Contrast Enhanced ImagingOther
Also called MRI
All MR examinations will be performed on a 3.0 Tesla whole body GE MR scanner located at the main campus (1275 York Avenue) or the Breast and Imaging Center (BAIC)(located on Second Ave. between 65th and 66th Streets). The MR examination will include MR imaging and spectroscopic imaging employing a combined torso phased array and endorectal coil receiver. The examination will require one hour to one hour and ten minutes.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients taking part in this study will have one MRI and one MRSI scan acquired in succession during a single MR examination. For those patients who have undergone prostate biopsy it is recommended that this should be done at least eight weeks after the prostate biopsy and should take one hour to one hour and ten minutes total to complete. Receives: Other: Magnetic Resonance Imaging; Spectroscopic Imaging, Contrast Enhanced Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define the relative proton metabolite levels detected by MRSI at 3.0 T in normal and cancerous tissue using pathology as the gold standard.
Measured: 3 years
Secondary outcomes (2)
To measure the sensitivity and specificity of localized detection of prostate cancer by 3.0 T MRSI using pathology as the gold standard.
Measured: 3 years
To explore whether metabolic markers measured by 3.0 T MRSI are correlated with prostate cancer aggressiveness as defined by the Gleason score.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2008 (estimated)
- Study start22 Aug 2006
- Primary completion6 Mar 2019
- Study completion6 Mar 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 Memorial Sloan Kettering 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
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yousef Mazaheri-Tehrani, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00588679
- Sponsor's protocol ID
- 06-035
- Status last verified
- Mar 2019
- First submitted
- 24 Dec 2007
- Last updated
- 8 Mar 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Spectroscopic Imaging of the Prostate at 3 Tesla
- ClinicalTrials.gov ID
- NCT00588679
- Acronym / sponsor ID
- 06-035
- Conditions
- Prostate Cancer, MRI
- Keywords
- Prostate Cancer, Cancer, MRI, Magnetic Resonance Imaging, 06-035
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 22 Aug 2006 (actual)
- Primary completion
- 6 Mar 2019 (actual)
- Study completion
- 6 Mar 2019 (actual)
- First posted
- 8 Jan 2008 (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 purpose of this study is to determine the benefits of Magnetic Resonance Imaging (MRI) combined with Magnetic Resonance Spectroscopic Imaging (MRSI), on an instrument called a 3.0 Tesla (T) MR scanner.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Magnetic Resonance Imaging; Spectroscopic Imaging, Contrast Enhanced ImagingPatients taking part in this study will have one MRI and one MRSI scan acquired in succession during a single MR examination. For those patients who have undergone prostate biopsy it is recommended that this should be done at least eight weeks after the prostate biopsy and should take one hour to one hour and ten minutes total to complete. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient must have clinically suspected or biopsy proven prostate cancer. If a patient has been diagnosed with prostate cancer an official report of biopsy from MSKCC or outside site is required. All outside pathology reports will be confirmed at MSKCC.
- For those patients who have undergone prostate biopsy it is recommended that the interval between biopsy and protocol MRI/MRSI should be at least 8 weeks.
- Patient is a potential surgical candidate for treatment of prostate cancer
- Patient is willing to undergo an endorectal MRI/MRSI exam on the 3.0T MR scanner
Key exclusion criteria (5 listed)
- Patients who because of general medical or psychiatric condition, or physiologic status unrelated to the presence of prostate cancer cannot give valid informed consent.
- Patients who are unwilling or unable to undergo MRI/MRSI (including patients with contra-indications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips.
- Patients who cannot tolerate or have contra-indications to endorectal coil insertion; for example, patients who have had a prior abdominoperineal resection of the rectum or have Crohn's disease, patients with severe hemorrhoids, patients who have had prior radiation to the pelvis to treat a malignancy, or patients who have had minor rectal surgery within the previous 8 weeks.
- Patients with an allergic reaction to latex.
- Patients with a metallic hip implant or any other metallic implant or device in the pelvis that might distort local magnetic field and compromise quality of MRI/MRSI.
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 |
|---|---|---|
| Magnetic Resonance Imaging; Spectroscopic Imaging, Contrast Enhanced ImagingAlso: MRIAll MR examinations will be performed on a 3.0 Tesla whole body GE MR scanner located at the main campus (1275 York Avenue) or the Breast and Imaging Center (BAIC)(located on Second Ave. between 65th and 66th Streets). The MR examination will include MR imaging and spectroscopic imaging employing a combined torso phased array and endorectal coil receiver. The examination will require one hour to one hour and ten minutes. | Other | 1 |
Primary outcome
To define the relative proton metabolite levels detected by MRSI at 3.0 T in normal and cancerous tissue using pathology as the gold standard.
Time frame: 3 years
2 secondary outcomes
To measure the sensitivity and specificity of localized detection of prostate cancer by 3.0 T MRSI using pathology as the gold standard.
Time frame: 3 years
To explore whether metabolic markers measured by 3.0 T MRSI are correlated with prostate cancer aggressiveness as defined by the Gleason score.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- Memorial Sloan Kettering web siteLink 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.
Yousef Mazaheri-Tehrani, PhD principal investigator
Memorial Sloan Kettering 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 Magnetic Resonance Imaging; Spectroscopic Imaging, Contrast Enhanced Imaging in people with Prostate Cancer and MRI, run by Memorial Sloan Kettering 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 5 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: finished, as of the sponsor's last update on 8 Mar 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To define the relative proton metabolite levels detected by MRSI at 3.0 T in normal and cancerous tissue using pathology as the gold standard. (time frame: 3 years). 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 8 Mar 2019.