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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00611065
Recruitment Status : Withdrawn (There is no funding to proceed.)
First Posted : February 8, 2008
Last Update Posted : February 16, 2009
Information provided by:
University of California, Irvine

Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Lesions Device: magnetic resonance imaging Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Imaging of Prostate Cancer Using Two-Dimensional MR Spectroscopy and Diffusion Tensor Imaging
Study Start Date : June 2007
Estimated Primary Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Device: magnetic resonance imaging
    MR contrast agent (0.1 mmol/kg)

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00611065

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

Responsible Party: Min-Ying Su, Associate Professor, University of California, Irvine Identifier: NCT00611065     History of Changes
Other Study ID Numbers: UCI-HS-2007-5671
First Posted: February 8, 2008    Key Record Dates
Last Update Posted: February 16, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases