Magnetic Resonance Spectroscopic Imaging of the Prostate at 3 Tesla

Tracking Information
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; (submitted: February 16, 2010)	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; (submitted: December 24, 2007)	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; (submitted: February 16, 2010)	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 ]
Original Secondary Outcome Measures ICMJE; (submitted: December 24, 2007)	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
Condition ICMJE	Prostate Cancer; MRI
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
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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Active, not recruiting
Actual Enrollment ICMJE; (submitted: April 26, 2016)	265
Original Estimated Enrollment ICMJE; (submitted: December 24, 2007)	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: 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 Exclusion Criteria: 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.
Sex/Gender	Sexes Eligible for Study: Male
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	Principal Investigator: Yousef Mazaheri-Tehrani, PhD Memorial Sloan Kettering Cancer Center
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