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

This study has been withdrawn prior to enrollment.
(There is no funding to proceed.)
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00611065
First received: January 12, 2008
Last updated: February 12, 2009
Last verified: February 2009
History of Changes
  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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Imaging of Prostate Cancer Using Two-Dimensional MR Spectroscopy and Diffusion Tensor Imaging

Resource links provided by NLM:

U.S. FDA Resources

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:
    Device: magnetic resonance imaging
    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:

  1. A male older than 21 years of age and under age of 80,
  2. 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:

  1. Unwilling to give informed consent,
  2. Have implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants,
  3. Have engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or have imbedded metal fragments from military activities,
  4. Have received orthodontic work involving ferromagnetic materials,
  5. Claustrophobic,
  6. Unable to lie down still for 60 minutes.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00611065

Locations
United States, California
Center for Functional Onco-Imaging, University of California
Irvine, California, United States, 92697
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Min-Ying Su, PhD University of California, Irvine
  More Information

No publications provided

Responsible Party: Min-Ying Su, Associate Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00611065     History of Changes
Other Study ID Numbers: UCI-HS-2007-5671
Study First Received: January 12, 2008
Last Updated: February 12, 2009
Health Authority: United States: Institutional Review Board

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 May 23, 2013