Multiparametric MRI for Prostate Cancer Localization and Characterization: New Methods
Primary Purpose
Prostate Cancer
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MRI with gadofosveset and MR elastography
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate cancer, MRI, Elastography, Gadofosveset
Eligibility Criteria
Inclusion Criteria:
- male patients diagnosed with T1C or T2 prostate cancer, awaiting prostatectomy
Exclusion Criteria:
- unable to give informed consent
- contraindication to MRI or MRI contrast agent
- claustrophobia
- renal impairment
- prior hormonal or radiation therapy for prostate cancer
- active prostatitis
- moderate to severe rectal inflammation
- previous rectal surgery
- prostate biopsy within 4 weeks of planned MRI
Sites / Locations
- Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm study
Arm Description
Outcomes
Primary Outcome Measures
Correlation coefficient
Correlation coefficient between the expected location and grade of prostate cancer as determined by each new MRI method compared with whole mount histological specimen using a 5 mm grid for spatial reference.
Receiver operator characteristic curve for the prediction of prostate cancer for each new MRI method
Secondary Outcome Measures
Full Information
NCT ID
NCT01761812
First Posted
January 1, 2013
Last Updated
October 17, 2016
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT01761812
Brief Title
Multiparametric MRI for Prostate Cancer Localization and Characterization: New Methods
Official Title
Determining the Extent and Grade of Prostate Cancer Using MR Elastography, Diffusion Weighted Imaging, and Dynamic Contrast Enhanced MRI With Gadofosveset
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Inadequate accrual
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the ability of several new MRI techniques (MR elastography, dynamic contrast-enhanced MRI with gadofosveset, and oscillating gradient diffusion) to determine the location, size, and grade of prostate carcinoma. Thirty patients with biopsy proven carcinoma awaiting prostatectomy will be included in the study. Ex-vivo MRI will also be conducted on the prostate specimen to obtain high resolution imaging correlates to both in-vivo MRI and whole mount prostatectomy specimens. The investigators hypothesize that the addition of these three techniques will increase the accuracy, sensitivity, and specificity of MRI for detecting clinically significant prostate cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer, MRI, Elastography, Gadofosveset
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm study
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
MRI with gadofosveset and MR elastography
Primary Outcome Measure Information:
Title
Correlation coefficient
Description
Correlation coefficient between the expected location and grade of prostate cancer as determined by each new MRI method compared with whole mount histological specimen using a 5 mm grid for spatial reference.
Time Frame
This outcome measure will be assessed approximately 4 weeks following prostatectomy (an average of 8 weeks from time of enrolment).
Title
Receiver operator characteristic curve for the prediction of prostate cancer for each new MRI method
Time Frame
This outcome measure will be assessed approximately 4 weeks following prostatectomy (an average of 8 weeks from time of enrolment).
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
male patients diagnosed with T1C or T2 prostate cancer, awaiting prostatectomy
Exclusion Criteria:
unable to give informed consent
contraindication to MRI or MRI contrast agent
claustrophobia
renal impairment
prior hormonal or radiation therapy for prostate cancer
active prostatitis
moderate to severe rectal inflammation
previous rectal surgery
prostate biopsy within 4 weeks of planned MRI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masoom A Haider, M.D.
Organizational Affiliation
Sunnybrook Health Sciences Centre, University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Multiparametric MRI for Prostate Cancer Localization and Characterization: New Methods
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