Viewing Study NCT00032058



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Last Modification Date: 2024-10-26 @ 9:07 AM
Study NCT ID: NCT00032058
Status: COMPLETED
Last Update Posted: 2011-02-21
First Post: 2002-03-08

Brief Title: Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in Diagnosing the Extent of Disease in Patients With Prostate Cancer
Sponsor: American College of Radiology Imaging Network
Organization: National Cancer Institute NCI

Study Overview

Official Title: MR Imaging And MR Spectroscopic Imaging Of Prostate Cancer Prior To Radical Prostatectomy A Prospective Multi-Institutional Clinicopathological Study
Status: COMPLETED
Status Verified Date: 2005-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: RATIONALE Imaging procedures such as magnetic resonance imaging MRI and magnetic resonance spectroscopic imaging MRSI may improve the ability to detect the extent of prostate cancer It is not yet known if MRI combined with MRSI is more effective than MRI alone in detecting the extent of prostate cancer

PURPOSE Diagnostic trial to compare the effectiveness of combining MRI with MRSI to that of MRI alone in determining the extent of prostate cancer in patients who are scheduled to undergo surgery to remove the prostate gland
Detailed Description: OBJECTIVES

Compare the accuracy of MRI vs MRI combined with magnetic resonance spectroscopic imaging MRSI for the localization of prostate cancer prior to radical prostatectomy in patients with stage I or II adenocarcinoma of the prostate
Compare the incremental benefit of these tests on diagnostic accuracy in these patients
Compare the incremental benefit of MRSI for interobserver agreement vs MRI alone in the localization of prostate cancer in these patients
Compare the accuracy of combined MRSI with that of other available information on tumor extent derived from digital rectal exam PSA level Gleason score and Partin nomogram in these patients

OUTLINE This is a multicenter study

At least 6 weeks after biopsy patients undergo MRI and magnetic resonance spectroscopic imaging MRSI over approximately 1 hour Within 6 months of MRIMRSI patients undergo radical prostatectomy

PROJECTED ACCRUAL A total of 134 patients will be accrued for this study within 7 months

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
Secondary ID Type Domain Link
ACRIN-6659 None None None