Back to resultsDefining the Extent and Grade of Prostate Cancer Using Dynamic Contrast Enhanced Diffusion Weighted and BOLD MRI
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MRI Prostate
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
Patients will be recruited from the University Health Network (UHN). Eligible patients will be undergoing radical prostatectomy for prostate cancer at UHN. Patients with a contraindication to MRI or MRI contrast agents, claustrophobia, renal failure, allergy to MRI contrast agents, or prior hormonal therapy or radiation therapy for prostate cancer, a biopsy within 3 weeks of the surgical date or active prostatitis will be excluded.
Sites / Locations
- University Health Network, Princess Margaret Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MRI - pathology
Arm Description
Outcomes
Primary Outcome Measures
Extent and Grade of Prostate Cancer Using MRI
Before undergoing surgery, all patients were examined with MR imaging
Secondary Outcome Measures
Full Information
NCT ID
NCT00242112
First Posted
October 18, 2005
Last Updated
April 24, 2017
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT00242112
Brief Title
Defining the Extent and Grade of Prostate Cancer Using Dynamic Contrast Enhanced Diffusion Weighted and BOLD MRI
Official Title
Defining the Extent and Grade of Prostate Cancer Using Dynamic Contrast Enhanced Diffusion Weighted and BOLD MRI
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the ability of functional MRI techniques to detect, measure and locate intra-prostatic cancer.
Detailed Description
The purpose of this study is to determine the ability of functional MRI techniques [High Resolution Dynamic Contrast Enhanced MRI (HR-DCE-MRI), diffusion weighted MRI (DWI) and BOLD MRI] to detect, measure and locate intra-prostatic cancer. 70 patients undergoing MRI for staging of prostate cancer prior to radical prostatectomy will be studied. Results of MRI obtained prior to surgery will be correlated with pathologic specimens to determine MRI accuracy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRI - pathology
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
MRI Prostate
Primary Outcome Measure Information:
Title
Extent and Grade of Prostate Cancer Using MRI
Description
Before undergoing surgery, all patients were examined with MR imaging
Time Frame
Imaging followed by pathology analysis
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients will be recruited from the University Health Network (UHN). Eligible patients will be undergoing radical prostatectomy for prostate cancer at UHN. Patients with a contraindication to MRI or MRI contrast agents, claustrophobia, renal failure, allergy to MRI contrast agents, or prior hormonal therapy or radiation therapy for prostate cancer, a biopsy within 3 weeks of the surgical date or active prostatitis will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masoom Haider, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network, Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Defining the Extent and Grade of Prostate Cancer Using Dynamic Contrast Enhanced Diffusion Weighted and BOLD MRI
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