Imaging of Prostate Cancer Using Two-Dimensional MR Spectroscopy and Diffusion Tensor Imaging - Full Text View

Imaging of Prostate Cancer Using Two-Dimensional MR Spectroscopy and Diffusion Tensor Imaging

This study is currently recruiting participants.
Verified by University of California, Irvine, July 2008

Sponsored by:	University of California, Irvine
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00611065

Purpose

The goal is to develop MR imaging techniques to improve delineation of cancer extent, and to improve differential diagnosis between prostate cancer and benign prostate hyperplasia or other benign diseases.

Condition	Intervention
Prostate Lesions	Device: magnetic resonance imaging

MedlinePlus related topics:

Cancer MRI Scans Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment

Official Title:	Imaging of Prostate Cancer Using Two-Dimensional MR Spectroscopy and Diffusion Tensor Imaging

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:

To demonstrate that multi-voxel MR spectroscopy and diffusion tensor imaging can accurately diagnose prostate cancer and benign diseases, also to provide an accurate disease extent. [ Time Frame: at completion of the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	June 2007
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Intervention Details:

MR contrast agent (0.1 mmol/kg)

Eligibility

Ages Eligible for Study:	21 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

A male older than 21 years of age and under age of 80,
Either a normal healthy volunteer; a patient who has confirmed prostate cancer and decided to receive prostatectomy; or a patient who has persistent elevated PSA higher than 4.0 ng/ml, and with a prior benign biopsy scheduled to receive the second biopsy.

Exclusion Criteria:

Unwilling to give informed consent,
Have implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants,
Have engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or have imbedded metal fragments from military activities,
Have received orthodontic work involving ferromagnetic materials,
Claustrophobic,
Unable to lie down still for 60 minutes.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611065

Contacts


Contact: Min-Ying Su, PhD	949-824-6001	msu@uci.edu

Locations


United States, California
	Center for Functional Onco-Imaging, University of California	Recruiting
	Irvine, California, United States, 92697
	Contact: Diane Huebner 949-824-6001 dkhuebne@uci.edu

Sponsors and Collaborators

University of California, Irvine

Investigators


Principal Investigator:	Min-Ying Su, PhD	University of California, Irvine

More Information

Responsible Party:	University of California, Irvine ( Min-Ying Su, Associate Professor )
Study ID Numbers:	UCI-HS-2007-5671
First Received:	January 12, 2008
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00611065
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Prostatic Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on October 15, 2008