Back to resultsImaging of Prostate Cancer Using Two-dimensional MR Spectroscopy and Diffusion Tensor Imaging
Primary Purpose
Prostate Lesions
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
magnetic resonance imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Lesions
Eligibility 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.
Sites / Locations
- Center for Functional Onco-Imaging, University of California
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00611065
First Posted
January 12, 2008
Last Updated
July 19, 2018
Sponsor
University of California, Irvine
1. Study Identification
Unique Protocol Identification Number
NCT00611065
Brief Title
Imaging of Prostate Cancer Using Two-dimensional MR Spectroscopy and Diffusion Tensor Imaging
Official Title
Imaging of Prostate Cancer Using Two-dimensional MR Spectroscopy and Diffusion Tensor Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Withdrawn
Why Stopped
There is no funding to proceed.
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of California, Irvine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Lesions
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
magnetic resonance imaging
Intervention Description
MR contrast agent (0.1 mmol/kg)
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min-Ying Su, PhD
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Functional Onco-Imaging, University of California
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Imaging of Prostate Cancer Using Two-dimensional MR Spectroscopy and Diffusion Tensor Imaging
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