Magnetic Resonance ImagingNCT02934776
Prospective Cohort Study of the Ability of MRI/DTI to Diagnose Prostate Cancer
A study testing MRI machine in people with Magnetic Resonance Imaging, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to examine if investigators can improve diagnosis of prostate cancer by using MRI/DTI? Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Magnetic Resonance Imaging
- What is being tested?
- MRI machine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1) Men who cannot complete the full acquisition of the MRI and the MRI/DTI image sequences for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read the 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
- Conditions
- Magnetic Resonance Imaging
- Being tested
- MRI machine
- Keywords
- DTI, prostate cancer, MRI
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI machineDevice
Also called Ingenia 3.0T
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.
| Study group | Role | What they receive |
|---|---|---|
| DTI acquisition | Experimental | Addition of up to 10 minutes in MRI machine purpose of acquiring additional DTI images Receives: Device: MRI machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare between number of prostate cancer diagnosed by mpMRI to the ones diagnosed by MRI/DTI
Measured: 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).
Measured: 1 year
Compare between MRI/DTI and MRI ability to identify low-grade and high-grade prostate cancer
Measured: 1 year
Compare between MRI/DTI and MRI in their ability to estimate tumor size.
Measured: 1 year
Compare between MRI/DTI and MRI in PiRAD grading
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance ImagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Weizmann Institute of Science
- Responsible party
- Principal investigator, david margel, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934776
- Sponsor's protocol ID
- 0357-16-RMC
- Status last verified
- Oct 2017
- First submitted
- 11 Oct 2016
- Last updated
- 10 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of the Ability of MRI/DTI to Diagnose Prostate Cancer in Men Undergoing Prostate MRI
- ClinicalTrials.gov ID
- NCT02934776
- Acronym / sponsor ID
- 0357-16-RMC
- Conditions
- Magnetic Resonance Imaging
- Keywords
- DTI, prostate cancer, MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Weizmann Institute of Science
- Study start
- Aug 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DTI acquisition | Experimental | Device: MRI machineAddition of up to 10 minutes in MRI machine purpose of acquiring additional DTI images |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 1) Men who cannot complete the full acquisition of the MRI and the MRI/DTI image sequences for any reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI machineAlso: Ingenia 3.0TThe 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. | Device | DTI acquisition |
Primary outcome
Compare between number of prostate cancer diagnosed by mpMRI to the ones diagnosed by MRI/DTI
Time frame: 1 year
4 secondary outcomes
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
Compare between MRI/DTI and MRI ability to identify low-grade and high-grade prostate cancer
Time frame: 1 year
Compare between MRI/DTI and MRI in their ability to estimate tumor size.
Time frame: 1 year
Compare between MRI/DTI and MRI in PiRAD grading
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI machine in people with Magnetic Resonance Imaging, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare between number of prostate cancer diagnosed by mpMRI to the ones diagnosed by MRI/DTI (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2017.