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Multiparametric MRI for Prostate Cancer Localization and Characterization: New Methods

This study has been terminated.
(Inadequate accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01761812
First Posted: January 7, 2013
Last Update Posted: October 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Masoom Haider, Sunnybrook Health Sciences Centre
  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
Prostate Cancer Other: MRI with gadofosveset and MR elastography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Masoom Haider, 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). ]
    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). ]

Enrollment: 5
Study Start Date: September 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm study Other: MRI with gadofosveset and MR elastography

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761812


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

Responsible Party: Masoom Haider, Staff Radiologist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01761812     History of Changes
Other Study ID Numbers: 334-2011
First Submitted: January 1, 2013
First Posted: January 7, 2013
Last Update Posted: October 18, 2016
Last Verified: October 2016

Keywords provided by Masoom Haider, 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