Prospective Cohort Study of the Ability of MRI/DTI to Diagnose Prostate Cancer
1 other identifier
interventional
200
1 country
1
Brief Summary
The purpose of this study is to examine if investigators can improve diagnosis of prostate cancer by using MRI/DTI?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 11, 2016
CompletedFirst Posted
Study publicly available on registry
October 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedOctober 10, 2017
October 1, 2017
2.3 years
October 11, 2016
October 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compare between number of prostate cancer diagnosed by mpMRI to the ones diagnosed by MRI/DTI
1 year
Secondary Outcomes (4)
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 cancer
1 year
Compare between MRI/DTI and MRI in their ability to estimate tumor size.
1 year
Compare between MRI/DTI and MRI in PiRAD grading
1 year
Study Arms (1)
DTI acquisition
EXPERIMENTALAddition of up to 10 minutes in MRI machine purpose of acquiring additional DTI images
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \) Men who cannot complete the full acquisition of the MRI and the MRI/DTI image sequences for any reason.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rabin Medical Centerlead
- Weizmann Institute of Sciencecollaborator
Study Sites (1)
Rabin Medical Center
Petah Tikva, 4941492, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Uro-Oncologist
Study Record Dates
First Submitted
October 11, 2016
First Posted
October 17, 2016
Study Start
August 1, 2016
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
October 10, 2017
Record last verified: 2017-10