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Clinical Trials/NCT01761812
NCT01761812
Terminated
Not Applicable

Determining the Extent and Grade of Prostate Cancer Using MR Elastography, Diffusion Weighted Imaging, and Dynamic Contrast Enhanced MRI With Gadofosveset

Sunnybrook Health Sciences Centre1 site in 1 country5 target enrollmentSeptember 2012
ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Sunnybrook Health Sciences Centre
Enrollment
5
Locations
1
Primary Endpoint
Correlation coefficient
Status
Terminated
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
December 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Masoom Haider

Staff Radiologist

Sunnybrook Health Sciences Centre

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

Outcomes

Primary Outcomes

Correlation coefficient

Time Frame: This outcome measure will be assessed approximately 4 weeks following prostatectomy (an average of 8 weeks from time of enrolment).

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

Time Frame: This outcome measure will be assessed approximately 4 weeks following prostatectomy (an average of 8 weeks from time of enrolment).

Study Sites (1)

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