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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02934776
Enrollment
200
Registered
2016-10-17
Start date
2016-08-31
Completion date
2018-12-31
Last updated
2017-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Magnetic Resonance Imaging

Keywords

DTI, prostate cancer, MRI

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

Interventions

DEVICEMRI 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.

Sponsors

Weizmann Institute of Science
CollaboratorOTHER
Rabin Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Compare between number of prostate cancer diagnosed by mpMRI to the ones diagnosed by MRI/DTI1 year

Secondary

MeasureTime frame
Compare the correlation of MRI/DTI parameters with prostate cancer diagnosis to the ones measured by mpMRI (ADC, and diffusion weighted images).1 year
Compare between MRI/DTI and MRI ability to identify low-grade and high-grade prostate cancer1 year
Compare between MRI/DTI and MRI in their ability to estimate tumor size.1 year
Compare between MRI/DTI and MRI in PiRAD grading1 year

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026