Prospective Cohort Study of the Ability of MRI/DTI to Diagnose Prostate Cancer

Study Overview
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Brief Summary
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The purpose of this study is to examine if investigators can improve diagnosis of prostate cancer by using MRI/DTI?

Detailed Description
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This is a prospective cohort study of the ability of MRI/DTI to diagnose prostate cancer in men undergoing prostate MRI. Study design: Male adults who are scheduled to undergo MRI of the prostate, for clinical reasons, will be subjected to additional 10 minutes of image acquisition inside the MRI machine. The added MRI/DTI acquisition does not involve injection of additional contrast material. Investigators will compare between ability of the full mp-MRI images to diagnose prostate cancer to that of the MRI/DTI images

Official Title
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Prospective Cohort Study of the Ability of MRI/DTI to Diagnose Prostate Cancer in Men Undergoing Prostate MRI

Conditions
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Magnetic Resonance Imaging

Intervention / Treatment
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* Device: MRI machine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men who are scheduled to undergo MRI of the prostate at the Department of Imaging, in Beilinson Hospital, Rabin Medical Center Age 18-90. Men who are willing and able to sign an informed consent form. Exclusion Criteria: 1) Men who cannot complete the full acquisition of the MRI and the MRI/DTI image sequences for any reason.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DTI acquisition<br>Addition of up to 10 minutes in MRI machine purpose of acquiring additional DTI images | Device: MRI machine<br>* The Philips Ingenia 3.0T is an MRI machine intended to be used by specialist radiologists in the hospital. It is able to acquire high quality images of wide variety of organs. For imaging the prostate, T2-weighted turbo spin-echo images are normally obtained in three orthogonal planes (axial, sagittal and coronal). This device is been clinically used in the MRI department in Belinson hospital.<br>* Other names: Ingenia 3.0T;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare between number of prostate cancer diagnosed by mpMRI to the ones diagnosed by MRI/DTI |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the correlation of MRI/DTI parameters with prostate cancer diagnosis to the ones measured by mpMRI (ADC, and diffusion weighted images). |  | 1 year | 
| Compare between MRI/DTI and MRI ability to identify low-grade and high-grade prostate cancer |  | 1 year | 
| Compare between MRI/DTI and MRI in their ability to estimate tumor size. |  | 1 year | 
| Compare between MRI/DTI and MRI in PiRAD grading |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DTI, prostate cancer, MRI