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Multiparametric MRI for Prostate Cancer Localization and Characterization: New Methods

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ClinicalTrials.gov Identifier: NCT01761812
Recruitment Status : Terminated (Inadequate accrual)
First Posted : January 7, 2013
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Masoom Haider, Sunnybrook Health Sciences Centre

Tracking Information
First Submitted Date  ICMJE January 1, 2013
First Posted Date  ICMJE January 7, 2013
Last Update Posted Date October 18, 2016
Study Start Date  ICMJE September 2012
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
  • 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). ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01761812 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multiparametric MRI for Prostate Cancer Localization and Characterization: New Methods
Official Title  ICMJE Determining the Extent and Grade of Prostate Cancer Using MR Elastography, Diffusion Weighted Imaging, and Dynamic Contrast Enhanced MRI With Gadofosveset
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Other: MRI with gadofosveset and MR elastography
Study Arms  ICMJE Experimental: Single arm study
Intervention: Other: MRI with gadofosveset and MR elastography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 17, 2016)
5
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2013)
30
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01761812
Other Study ID Numbers  ICMJE 334-2011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Masoom Haider, Sunnybrook Health Sciences Centre
Study Sponsor  ICMJE Sunnybrook Health Sciences Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Masoom A Haider, M.D. Sunnybrook Health Sciences Centre, University of Toronto
PRS Account Sunnybrook Health Sciences Centre
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP