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

Primary Purpose

Magnetic Resonance Imaging

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
MRI machine
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Magnetic Resonance Imaging focused on measuring DTI, prostate cancer, MRI

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

  • Rabin Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DTI acquisition

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 11, 2016
Last Updated
October 9, 2017
Sponsor
Rabin Medical Center
Collaborators
Weizmann Institute of Science
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1. Study Identification

Unique Protocol Identification Number
NCT02934776
Brief Title
Prospective Cohort Study of the Ability of MRI/DTI to Diagnose Prostate Cancer
Official Title
Prospective Cohort Study of the Ability of MRI/DTI to Diagnose Prostate Cancer in Men Undergoing Prostate MRI
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
Collaborators
Weizmann Institute of Science

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Magnetic Resonance Imaging
Keywords
DTI, prostate cancer, MRI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DTI acquisition
Arm Type
Experimental
Arm Description
Addition of up to 10 minutes in MRI machine purpose of acquiring additional DTI images
Intervention Type
Device
Intervention Name(s)
MRI machine
Other Intervention Name(s)
Ingenia 3.0T
Intervention Description
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.
Primary Outcome Measure Information:
Title
Compare between number of prostate cancer diagnosed by mpMRI to the ones diagnosed by MRI/DTI
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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
Title
Compare between MRI/DTI and MRI ability to identify low-grade and high-grade prostate cancer
Time Frame
1 year
Title
Compare between MRI/DTI and MRI in their ability to estimate tumor size.
Time Frame
1 year
Title
Compare between MRI/DTI and MRI in PiRAD grading
Time Frame
1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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 Age 18-90. 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.
Facility Information:
Facility Name
Rabin Medical Center
City
Petah-Tikva
ZIP/Postal Code
4941492
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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