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

Not Applicable

• Conditions: Magnetic Resonance Imaging
• Interventions: Device: MRI machine

• Registration Number: NCT02934776
• Lead Sponsor: Rabin Medical Center

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-10-13
• Study First Posted: 2016-10-17
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-09
• Last Update Posted: 2017-10-10
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

1. Men who are scheduled to undergo MRI of the prostate at the Department of Imaging, in Beilinson Hospital, Rabin Medical Center
2. Age 18-90.
3. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DTI acquisition	MRI machine	Addition of up to 10 minutes in MRI machine purpose of acquiring additional DTI images

Primary Outcome Measures

Name	Time	Method
Compare between number of prostate cancer diagnosed by mpMRI to the ones diagnosed by MRI/DTI	1 year

Secondary Outcome Measures

Name	Time	Method
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 PiRAD grading	1 year
Compare between MRI/DTI and MRI in their ability to estimate tumor size.	1 year

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petah-Tikva, Israel