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The Value of MultiSpectral 3 Tesla MRI in Active Surveillance of Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01896713
Recruitment Status : Completed
First Posted : July 11, 2013
Last Update Posted : July 11, 2013
Sponsor:
Collaborator:
Philips Healthcare
Information provided by (Responsible Party):
Masoom Haider, Sunnybrook Health Sciences Centre

Tracking Information
First Submitted Date  ICMJE January 7, 2013
First Posted Date  ICMJE July 11, 2013
Last Update Posted Date July 11, 2013
Study Start Date  ICMJE April 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2013)
The Positive Predictive Value (PPV) of MS3TMRI-TRUSBx for detection of a patient with a cancer burden requiring consideration of immediate therapy. [ Time Frame: The outcome measure will be evaluated at the time of the results of the TRUSbx which will be approximately 2 weeks after the biopsy ]
Compare the targeted biopsy to the random biopsies
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2013)
The number of cores required for diagnosis of prostate cancer for MS3TMRI-TRUSBx versus TRUSBx alone [ Time Frame: The outcome measure will be evaluated at the time of the results of the TRUSbx which will be approximately 2 weeks after the biopsy ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Value of MultiSpectral 3 Tesla MRI in Active Surveillance of Prostate Cancer
Official Title  ICMJE To Determine if MultiSpectral 3 Tesla MRI Can Provide Added Value in the Detection of Significant Cancers in Patients o n Active Surveillance for Prostate Cancer
Brief Summary MultiSpectral 3 Tesla MRI (MS3TMRI) can increase the yield of Trans Rectal Ultrasound Biopsy (TRUSBx) to improve identification of patients on active surveillance requiring treatment.
Detailed Description This is a prospective single arm study. 120 patients at risk for significant occult prostate cancer on an active surveillance program will undergo MS3TMRI followed by a standard TRUSBx and additional biopsies guided by the MS3TMRI results. The positive predictive value (PPV) of MS3TMRI-TRUSBx for cancer requiring consideration of therapy will be compared to the PPV of TRUSBx alone. MS3TMRI consists of T2, diffusion-weighted imaging (DWI), dynamic contrast enhanced MRI (DCEMRI), proton MR spectroscopy (MRS) interpreted by a radiologist and by CAD methods validated on whole mount prostate specimens.
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: MS3TMRI
Multispectral 3 Tesla MRI imaging with contrast followed by biopsy
Other Name: Multispectral 3 Tesla MRI imaging
Study Arms  ICMJE Diagnostic: Single Arm
Imaging (MS3TMRI)
Intervention: Other: MS3TMRI
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 Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2013)
81
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Enrolled in active surveillance at Sunnybrook Health Sciences Centre, requiring biopsy as part of surveillance protocol.
  • Clinically eligible for radical prostatectomy and willing to undergo surgery
  • Clinically eligible for and willing to undergo ultrasound biopsy within 8 weeks of MRI

Exclusion Criteria:

  • Claustrophobia
  • Contraindication to MRI
  • Contraindication to receiving low molecular weight MRI contrast agent
  • Prior hormone therapy except 5-alpha reductase inhibitors such as Avodart. FloMax etc
  • Clinically suspected or known compromised renal function or calculated estimated Glomerular Filtration Rate (eGFR) <30ml/min
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 NCT01896713
Other Study ID Numbers  ICMJE 154-2009
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 Philips Healthcare
Investigators  ICMJE
Principal Investigator: Masoom Haider, MD Sunnybrook Health Sciences Centre, University of Toronto
PRS Account Sunnybrook Health Sciences Centre
Verification Date July 2013

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