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

Clalit Health Services

Status: Unknown

Conditions: Magnetic Resonance Imaging

Treatments: Device: MRI machine

Study type: Interventional

Funder types: Other

Identifiers

NCT02934776

0357-16-RMC

Details and patient eligibility

About

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

Full 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

Enrollment: 200 estimated patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

DTI acquisition

Experimental group

Description:

Addition of up to 10 minutes in MRI machine purpose of acquiring additional DTI images

Treatment:

Device: MRI machine