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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03585660
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Description
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Brief Summary:
The purpose of the proposed research is to test and validate a Risk Map decision-support system (DSS) for prostate cancer Magnetic Resonance Imaging (MRI) interpretation and identification of clinically significant tumor site(s).

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Diagnostic MRI Procedure: Diagnostic Prostate Biopsy Device: Risk Map DSS tool Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: MRI Derived Quantitative Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy
Actual Study Start Date : June 19, 2018
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Interventional Arm
Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of biopsy samples positive for prostate cancer versus those that are negative as assessed by receiver operating characteristic curve [ Time Frame: 12 months ]
  2. Rate of biopsy samples positive for prostate cancer versus those that are negative as assessed by area under the curve [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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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): NCT03585660


Contacts
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Contact: Ambereen Yousuf (773) 702-6003 ayousuf@radiology.bsd.uchicago.edu

Locations
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United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Ambereen Yousuf    773-702-6003    ayousuf@radiology.bsd.uchicago.edu   
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Aytekin Oto, MD University of Chicago
More Information
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03585660    
Other Study ID Numbers: IRB17-1694
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases