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

NCT ID: NCT02934776

Last Updated: 2017-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-12-31

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

Conditions

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Magnetic Resonance Imaging

Keywords

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DTI prostate cancer MRI

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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DTI acquisition

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

Group Type EXPERIMENTAL

MRI machine

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Ingenia 3.0T

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Weizmann Institute of Science

OTHER

Sponsor Role collaborator

Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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david margel

Staff Uro-Oncologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rabin Medical Center

Petah Tikva, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0357-16-RMC

Identifier Type: -

Identifier Source: org_study_id