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Multiparametric MRI for Prostate Cancer Localization and Characterization: New Methods

This study is currently recruiting participants.
Verified January 2013 by Sunnybrook Health Sciences Centre
Sponsor:
Information provided by (Responsible Party):
Masoom Haider, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01761812
First received: January 1, 2013
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
 Other: MRI with gadofosveset and MR elastography
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Determining the Extent and Grade of Prostate Cancer Using MR Elastography, Diffusion Weighted Imaging, and Dynamic Contrast Enhanced MRI With Gadofosveset

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Correlation coefficient [ Time Frame: This outcome measure will be assessed approximately 4 weeks following prostatectomy (an average of 8 weeks from time of enrolment). ] [ Designated as safety issue: No ]
    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). ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm study Other: MRI with gadofosveset and MR elastography

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761812

Contacts
Contact: Masoom A Haider, M.D. 416 480-6100 ext 1491 m.haider@utoronto.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Principal Investigator: Masoom A Haider, M.D.            
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Masoom A Haider, M.D. Sunnybrook Health Sciences Centre, University of Toronto
  More Information

No publications provided

Responsible Party: Masoom Haider, Staff Radiologist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01761812     History of Changes
Other Study ID Numbers: 334-2011
Study First Received: January 1, 2013
Last Updated: January 3, 2013
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
Prostate cancer
MRI
Elastography
Gadofosveset

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013