Liver DiseaseNCT02186054
T2 Weighted Imaging of the Liver With Fast Spin Echo MRI
A study testing MRI examinations in people with Liver Disease, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The purpose of this study is to test two new MRI (magnetic resonance imaging) sequences to see how they compare to previously used imaging sequences as they may improve the quality of abdominal MRI. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Disease
- What is being tested?
- MRI examinations
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2014to Jun 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing routine liver MRI imaged with one of our 4 clinical scanners (MR 750W, General Electric, Milwaukee WI)
Who cannot join
- Patients not undergoing routine liver MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancement of T2 Weighted Imaging of the Liver With Fast Spin Echo Magnetic Resonance Imaging (MRI).
The purpose of this study is to test two new MRI (magnetic resonance imaging) sequences to see how they compare to previously used imaging sequences as they may improve the quality of abdominal MRI.
Read the detailed description
- Approximately 50 patients undergoing routine liver MRI in our practice imaged with one of our 4 clinical scanners will undergo our standard liver MRI protocol with the addition of 2 breath-hold sequences (FSE Flex and eSSFSE) only increasing the scan time by approximately 3 minutes.
- Data will be retrieved from examinations that have been performed from the patient's electronic imaging file stored in our picture archiving and communication system (PACS).
- Images will be completely anonymized. No patient identifiers will be available on the images during the analysis.
- Analyses will include the visual assessment of image quality, presence and severity of imaging artifact and other non-invasive imaging outcomes performed by radiologists blinded to patient information and the type of sequence performed. Data will be presented in a Likert type scale (1=poor, 2=suboptimal, 3=average, 4=above average and 5=excellent) and imaging parameters will be compared using the Wilcoxon sign rank test.
- Conditions
- Liver Disease
- Being tested
- MRI examinations
- Keywords
- Abdominal-Pelvic MRI (magnetic resonance image), T2W (T2 weighted), FSE Flex (recently developed MRI pulse sequence), Enhanced single shot FSE (fast spin echo).
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI examinationsDevice
Also called MRI, FSE Flex, Enhanced single shot FSE (eSSFSE)
Consented patients will be required to stay in the MRI scanner to complete the 2 additional sequences once their standard exam is completed.
| Study group | Role | What they receive |
|---|---|---|
| Imaging- MRI examinations | Other | Liver MRI imaging will be performed on 50 patients. Receives: Device: MRI examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of abdominal MRI scans deemed improved quality
Data is presented in a Likert type scale (1=poor, 2=suboptimal, 3=average, 4=above average and 5=excellent) and imaging parameters are compared using the Wilcoxon sign rank test.
Measured: Regular scan time with one of 4 clinical scanners plus 3 additional minutes
Secondary outcomes (1)
The number of MRI scans that display severity of imaging artifact
Data is presented in a Likert type scale (1=poor, 2=suboptimal, 3=average, 4=above average and 5=excellent) and imaging parameters are compared using the Wilcoxon sign rank test.
Measured: Regular scan time with one of 4 clinical scanners plus 3 additional minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Why it stopped: Trial Logistics
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nick Schieda, MD, Principal investigator, OHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186054
- Sponsor's protocol ID
- T2 Weighted MRI Liver
- Status last verified
- Nov 2015
- First submitted
- 4 Jul 2014
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancement of T2 Weighted Imaging of the Liver With Fast Spin Echo Magnetic Resonance Imaging (MRI).
- ClinicalTrials.gov ID
- NCT02186054
- Acronym / sponsor ID
- T2 Weighted MRI Liver
- Conditions
- Liver Disease
- Keywords
- Abdominal-Pelvic MRI (magnetic resonance image), T2W (T2 weighted), FSE Flex (recently developed MRI pulse sequence), Enhanced single shot FSE (fast spin echo).
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial Logistics
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 10 Jul 2014 (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 test two new MRI (magnetic resonance imaging) sequences to see how they compare to previously used imaging sequences as they may improve the quality of abdominal MRI.
Detailed description
- Approximately 50 patients undergoing routine liver MRI in our practice imaged with one of our 4 clinical scanners will undergo our standard liver MRI protocol with the addition of 2 breath-hold sequences (FSE Flex and eSSFSE) only increasing the scan time by approximately 3 minutes.
- Data will be retrieved from examinations that have been performed from the patient's electronic imaging file stored in our picture archiving and communication system (PACS).
- Images will be completely anonymized. No patient identifiers will be available on the images during the analysis.
- Analyses will include the visual assessment of image quality, presence and severity of imaging artifact and other non-invasive imaging outcomes performed by radiologists blinded to patient information and the type of sequence performed. Data will be presented in a Likert type scale (1=poor, 2=suboptimal, 3=average, 4=above average and 5=excellent) and imaging parameters will be compared using the Wilcoxon sign rank test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging- MRI examinations | Other | Device: MRI examinationsLiver MRI imaging will be performed on 50 patients. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing routine liver MRI imaged with one of our 4 clinical scanners (MR 750W, General Electric, Milwaukee WI)
Key exclusion criteria (1 listed)
- Patients not undergoing routine liver MRI
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 examinationsAlso: MRI, FSE Flex, Enhanced single shot FSE (eSSFSE)Consented patients will be required to stay in the MRI scanner to complete the 2 additional sequences once their standard exam is completed. | Device | Imaging- MRI examinations |
Primary outcome
The number of abdominal MRI scans deemed improved quality
Time frame: Regular scan time with one of 4 clinical scanners plus 3 additional minutes
Data is presented in a Likert type scale (1=poor, 2=suboptimal, 3=average, 4=above average and 5=excellent) and imaging parameters are compared using the Wilcoxon sign rank test.
1 secondary outcome
The number of MRI scans that display severity of imaging artifact
Time frame: Regular scan time with one of 4 clinical scanners plus 3 additional minutes
Results and safety
The study was stopped early (reason given: Trial Logistics). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
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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.
Nick Schieda, MD principal investigator
OHRI
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 examinations in people with Liver Disease, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 1 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: stopped early, as of the sponsor's last update on 18 Nov 2015. 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 Canada. 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?
The study was stopped early (reason given: Trial Logistics). 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?
The number of abdominal MRI scans deemed improved quality (time frame: Regular scan time with one of 4 clinical scanners plus 3 additional minutes). 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 18 Nov 2015.