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

October 9, 2017 updated by: david margel, Rabin Medical Center

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petah-Tikva, Israel, 4941492
        • Rabin Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DTI acquisition
Addition of up to 10 minutes in MRI machine purpose of acquiring additional DTI images
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.
Other Names:
  • Ingenia 3.0T

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare between number of prostate cancer diagnosed by mpMRI to the ones diagnosed by MRI/DTI
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare the correlation of MRI/DTI parameters with prostate cancer diagnosis to the ones measured by mpMRI (ADC, and diffusion weighted images).
Time Frame: 1 year
1 year
Compare between MRI/DTI and MRI ability to identify low-grade and high-grade prostate cancer
Time Frame: 1 year
1 year
Compare between MRI/DTI and MRI in their ability to estimate tumor size.
Time Frame: 1 year
1 year
Compare between MRI/DTI and MRI in PiRAD grading
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Collaborators

Weizmann Institute of Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

October 11, 2016

First Submitted That Met QC Criteria

October 13, 2016

First Posted (Estimate)

October 17, 2016

Study Record Updates

Last Update Posted (Actual)

October 10, 2017

Last Update Submitted That Met QC Criteria

October 9, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0357-16-RMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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