Back to resultsDeveloping an Imaging-Based Tool to Identify Areas for Prostate Cancer Biopsy
Primary Purpose
Prostate Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diagnostic MRI
Diagnostic Prostate Biopsy
Risk Map DSS tool
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility 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).
Sites / Locations
- University of Chicago Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Interventional Arm
Arm Description
Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors.
Outcomes
Primary Outcome Measures
Rate of biopsy samples positive for prostate cancer versus those that are negative as assessed by receiver operating characteristic curve
Rate of biopsy samples positive for prostate cancer versus those that are negative as assessed by area under the curve
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03585660
Brief Title
Developing an Imaging-Based Tool to Identify Areas for Prostate Cancer Biopsy
Official Title
MRI Derived Quantitative Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2018 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional Arm
Arm Type
Experimental
Arm Description
Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors.
Intervention Type
Procedure
Intervention Name(s)
Diagnostic MRI
Intervention Description
Participants will be scanned using a standard clinical prostate MRI protocol.
Intervention Type
Procedure
Intervention Name(s)
Diagnostic Prostate Biopsy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Risk Map DSS tool
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of biopsy samples positive for prostate cancer versus those that are negative as assessed by receiver operating characteristic curve
Time Frame
12 months
Title
Rate of biopsy samples positive for prostate cancer versus those that are negative as assessed by area under the curve
Time Frame
12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ambereen Yousuf
Phone
(773) 702-6003
Email
ayousuf@radiology.bsd.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aytekin Oto, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ambereen Yousuf
Phone
773-702-6003
Email
ayousuf@radiology.bsd.uchicago.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Developing an Imaging-Based Tool to Identify Areas for Prostate Cancer Biopsy
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