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

Magnetic Resonance Imaging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02934776
• Other study ID #: 0357-16-RMC
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 11, 2016
• Last updated: October 9, 2017
• Start date: August 2016
• Est. completion date: December 2018

Study information

• Verified date: October 2017
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Magnetic Resonance Imaging
• Prostatic Neoplasms

Intervention

Device:
• MRI machine
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.

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petah-Tikva

Sponsors (2)

Lead Sponsor	Collaborator
Rabin Medical Center	Weizmann Institute of Science

Country where clinical trial is conducted

Israel, 

Outcome

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