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Magnetic Resonance Spectroscopic Imaging of the Prostate at 3 Tesla

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00588679
First received: December 24, 2007
Last updated: April 26, 2016
Last verified: April 2016
History of Changes

December 24, 2007
April 26, 2016
August 2006
August 2017   (final data collection date for 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00588679 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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Magnetic Resonance Spectroscopic Imaging of the Prostate at 3 Tesla
Magnetic Resonance Spectroscopic Imaging of the Prostate at 3 Tesla
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.
Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Prostate Cancer
  • MRI
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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
265
August 2017
August 2017   (final data collection date for primary outcome measure)

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.
Male
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00588679
06-035
Not Provided
Not Provided
Not Provided
Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
Not Provided
Principal Investigator: Yousef Mazaheri-Tehrani, PhD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP