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Clinical Trials/NCT02934776
NCT02934776
Unknown
N/A

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

Rabin Medical Center1 site in 1 country200 target enrollmentAugust 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Magnetic Resonance Imaging
Sponsor
Rabin Medical Center
Enrollment
200
Locations
1
Primary Endpoint
Compare between number of prostate cancer diagnosed by mpMRI to the ones diagnosed by MRI/DTI
Last Updated
8 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
December 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

david margel

Staff Uro-Oncologist

Rabin Medical Center

Eligibility Criteria

Inclusion Criteria

  • Men who are scheduled to undergo MRI of the prostate at the Department of Imaging, in Beilinson Hospital, Rabin Medical Center
  • Men who are willing and able to sign an informed consent form.

Exclusion Criteria

  • Men who cannot complete the full acquisition of the MRI and the MRI/DTI image sequences for any reason.

Outcomes

Primary Outcomes

Compare between number of prostate cancer diagnosed by mpMRI to the ones diagnosed by MRI/DTI

Time Frame: 1 year

Secondary Outcomes

  • 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)

Study Sites (1)

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