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Developing an Imaging-Based Tool to Identify Areas for Prostate Cancer Biopsy

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ClinicalTrials.gov Identifier: NCT03585660
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date  ICMJE June 19, 2018
First Posted Date  ICMJE July 13, 2018
Last Update Posted Date July 13, 2018
Actual Study Start Date  ICMJE June 19, 2018
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
  • Rate of biopsy samples positive for prostate cancer versus those that are negative as assessed by receiver operating characteristic curve [ Time Frame: 12 months ]
  • Rate of biopsy samples positive for prostate cancer versus those that are negative as assessed by area under the curve [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
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 Developing an Imaging-Based Tool to Identify Areas for Prostate Cancer Biopsy
Official Title  ICMJE MRI Derived Quantitative Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy
Brief Summary The purpose of the proposed research is to test and validate an artificial intelligence-based Risk Map decision-support system (DSS) for prostate cancer Magnetic Resonance Imaging (MRI) interpretation and identification of clinically significant tumor site(s).
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
  • Procedure: Diagnostic MRI
    Participants will be scanned using a standard clinical prostate MRI protocol.
  • Procedure: Diagnostic Prostate Biopsy
    Participants will undergo a prostate biopsy as their standard of care treatment. The provider performing biopsy will select areas to be biopsies as part of normal clinical judgment.
  • Device: Risk Map DSS tool
    The Risk Map DSS tool will select up to 2 additional areas to be biopsied based on analysis of MRI images. The clinical provider will make final decision on areas to be biopsied.
Study Arms  ICMJE Experimental: Interventional Arm
Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors.
Interventions:
  • Procedure: Diagnostic MRI
  • Procedure: Diagnostic Prostate Biopsy
  • Device: Risk Map DSS tool
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with known or suspected prostate cancer who have been referred to the Department of Radiology at the University of Chicago Medical Center for a diagnostic MRI exam of the prostate, to be followed by an MRI-guided fusion biopsy of the prostate.
  • Written informed consent.

Exclusion Criteria:

  • Patients incapable of giving informed written consent;
  • Patients who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher;
  • Patients with psychiatric disorders that affect their ability to consent for themselves will be excluded and not the entire population of patients with psychiatric disorders.
  • Prisoners;
  • Minor children (under the age of 18 years old).
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: Ambereen Yousuf (773) 702-6003 ayousuf@radiology.bsd.uchicago.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03585660
Other Study ID Numbers  ICMJE IRB17-1694
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aytekin Oto, MD University of Chicago
PRS Account University of Chicago
Verification Date July 2018

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