- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00611065
Imaging of Prostate Cancer Using Two-dimensional MR Spectroscopy and Diffusion Tensor Imaging
July 19, 2018 updated by: University of California, Irvine
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Irvine, California, United States, 92697
- Center for Functional Onco-Imaging, University of California
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
at completion of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Min-Ying Su, PhD, University of California, Irvine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Anticipated)
June 1, 2009
Study Registration Dates
First Submitted
January 12, 2008
First Submitted That Met QC Criteria
January 25, 2008
First Posted (Estimate)
February 8, 2008
Study Record Updates
Last Update Posted (Actual)
July 20, 2018
Last Update Submitted That Met QC Criteria
July 19, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCI-HS-2007-5671
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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