Magnetic Resonance Spectroscopic Imaging of the Prostate at 3 Tesla
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ClinicalTrials.gov Identifier: NCT00588679 |
Recruitment Status
:
Active, not recruiting
First Posted
: January 8, 2008
Last Update Posted
: April 18, 2018
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Sponsor:
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
Tracking Information | ||||
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First Submitted Date ICMJE | December 24, 2007 | |||
First Posted Date ICMJE | January 8, 2008 | |||
Last Update Posted Date | April 18, 2018 | |||
Study Start Date ICMJE | August 2006 | |||
Estimated Primary Completion Date | August 2019 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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 ] | |||
Original Primary Outcome Measures ICMJE |
Define the relative proton metabolite levels detected by MRSI at 3.0 T in normal and cancerous tissue; measure the sensitivity and specificity of localized detection of prostate cancer by 3.0 T MRSI using pathology. [ Time Frame: 3 years ] | |||
Change History | Complete list of historical versions of study NCT00588679 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Explore whether metabolic markers measured by 3.0 T MRSI are correlated with prostate cancer aggressiveness; measure ADC values for benign and malignant prostate tissue and to assess the ability of DWI in differentiating malignant from benign. [ Time Frame: 3 years ] | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Magnetic Resonance Spectroscopic Imaging of the Prostate at 3 Tesla | |||
Official Title ICMJE | Magnetic Resonance Spectroscopic Imaging of the Prostate at 3 Tesla | |||
Brief 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE |
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Intervention ICMJE | Other: Magnetic Resonance Imaging; Spectroscopic Imaging, Contrast Enhanced Imaging
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.
Other Name: MRI |
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Study Arms | Experimental: 1
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.
Intervention: Other: Magnetic Resonance Imaging; Spectroscopic Imaging, Contrast Enhanced Imaging |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE |
265 | |||
Original Estimated Enrollment ICMJE |
154 | |||
Estimated Study Completion Date | August 2019 | |||
Estimated Primary Completion Date | August 2019 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 21 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00588679 | |||
Other Study ID Numbers ICMJE | 06-035 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Memorial Sloan Kettering Cancer Center | |||
Study Sponsor ICMJE | Memorial Sloan Kettering Cancer Center | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Memorial Sloan Kettering Cancer Center | |||
Verification Date | April 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |