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

Prostate Lesions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00611065
• Other study ID #: UCI-HS-2007-5671
• Status: Withdrawn
• Phase: N/A
• Start date: June 2007

Study information

• Verified date: July 2018
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Lesions
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Center for Functional Onco-Imaging, University of California	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		at completion of the study