Magnetic Resonance Spectroscopic Imaging of the Prostate at 3 Tesla - Full Text View

Sponsor:	Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00588679

Purpose

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.

Condition	Intervention
Prostate Cancer MRI	Other: Magnetic Resonance Imaging; Spectroscopic Imaging, Contrast Enhanced Imaging

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Magnetic Resonance Spectroscopic Imaging of the Prostate at 3 Tesla

Resource links provided by NLM:

MedlinePlus related topics: Cancer MRI Scans Prostate Cancer

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	308
Study Start Date:	August 2006
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Patients taking part in this study will have one MRI and one MRSI scan acquired in succession during a single MR examination. It is recommended that this will be done at least eight weeks after the prostate biopsy and should take one hour to one hour and ten minutes total to complete.	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

Arms

Assigned Interventions

Experimental: 1

Patients taking part in this study will have one MRI and one MRSI scan acquired in succession during a single MR examination. It is recommended that this will be done at least eight weeks after the prostate biopsy and should take one hour to one hour and ten minutes total to complete.

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

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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.
It is recommended that the interval between biopsy and protocol MRI/MRSI 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588679

Contacts

Contact: Yousef Mazaheri-Tehrani, Ph.D.

212-639-6913

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Yousef Mazaheri-Tehrani, PhD 212-639-6913

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Yousef Mazaheri-Tehrani, PhD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering web site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00588679 History of Changes
Other Study ID Numbers:	06-035
Study First Received:	December 24, 2007
Last Updated:	January 17, 2012
Health Authority:	United States: Food and Drug Administration; Unites States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Prostate Cancer
Cancer
MRI
Magnetic Resonance Imaging
06-035

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012