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

NCT03585660 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2024-09-19

Study results available
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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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Aytekin Oto, MD · University of Chicago

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-28
Primary Completion
2023-06-09
Completion
2023-11-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03585660 on ClinicalTrials.gov