Trials / Completed
CompletedNCT03585660
Developing an Imaging-Based Tool to Identify Areas for Prostate Cancer Biopsy
MRI Derived Quantitative Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 106 (actual)
- Sponsor
- University of Chicago · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-08-28
- Primary completion
- 2023-06-09
- Completion
- 2023-11-06
- First posted
- 2018-07-13
- Last updated
- 2024-09-19
- Results posted
- 2024-09-19
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03585660. Inclusion in this directory is not an endorsement.