Liver DiseasesNCT03260660
Comparison of MR Elastography Methods Without and With Compressed Sensing
An observational study of Liver Diseases, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
In this research study, the investigators will compare the liver stiffness results obtained from the current Magnetic Resonance Imaging (MRI) method to liver stiffness results obtained from a method that uses faster imaging techniques. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Diseases
- What is being tested?
- Magnetic Resonance Elastography
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2017to 1 Dec 2017
- Phase
- Observational
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Volunteers
Who may be able to join
- Adult volunteers ≥18 years of age
- Ability to tolerate 30 minutes in an MRI scanner.
- Nothing to eat or drink for 4 hours prior to the MRI scan
Who cannot join
- No contraindication to MR imaging (e.g., implanted non-MRI compatible device)
- Known or suspected pregnancy. Female subjects of child bearing potential will undergo a urine pregnancy test prior to imaging.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
In this research study, the investigators will compare the liver stiffness results obtained from the current Magnetic Resonance Imaging (MRI) method to liver stiffness results obtained from a method that uses faster imaging techniques.
Read the detailed description
MR elastography is increasingly used to assess liver stiffness in pediatric and adult patients with chronic liver diseases. While numerous tissue abnormalities can affect liver stiffness, liver stiffness measured by MR elastography is most often used to predict and quantify liver fibrosis. Conventional MR elastography techniques require multiple breath-holds that are 12-20 seconds in length. In the pediatric population, reliable breath-holding >10 seconds can be challenging. Recently, compressed sensing has become available as a method for accelerating image data acquisition, and thus shortening breath-holds.
- Conditions
- Liver Diseases
- Being tested
- Magnetic Resonance Elastography
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ElastographyDevice
The investigators plan to prospectively assess the agreement of liver stiffness measurements obtained using standard of care MR elastography techniques vs. MR elastography with varying amounts of imaging acceleration using compressed sensing in adult volunteers
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard Magnetic Resonance Elastography versus Elastography with Compressed Sensing (x1.5)
Four MR elastography images through the mid liver will be obtained using standard MR elastography and MR elastography with 1.5 times the amount of standard Sensing applied. Correlation Coefficient will be determined for resulting elastography data.
Measured: 30 minutes
Standard Magnetic Resonance Elastography versus Elastography with Compressed Sensing (x2)
Four MR elastography images through the mid liver will be obtained using standard MR elastography and MR elastography with 2 times the amount of standard sensing applied. correlation coefficient will be determined for resulting elastography data.
Measured: 30 minutes
Standard Magnetic Resonance Elastography versus Elastography with Compressed Sensing (x3)
Four MR elastography images through the mid liver will be obtained using standard MR elastography and MR elastography with 3 times the amount of standard Sensing applied. Correlation coefficient will be determined for resulting elastography data.
Measured: 30 minutes
Secondary outcomes (2)
Standard Magnetic Resonance Elastography versus respiratory triggered Magnetic Resonance Elastography.
Four MR elastography images through the mid liver will be obtained using standard MR elastography and MR elastography acquired using respiratory triggered Gradient Recalled Elastography. Correlation coefficient will be determined for resulting elastography data.
Measured: 30 minutes
Standard Magnetic Resonance Elastography versus navigated triggered Magnetic Resonance Elastography.
Four MR elastography images through the mid liver will be obtained using standard MR elastography and MR elastography acquired using navigated triggered Gradient Recalled Elastography. Correlation coefficient will be determined for resulting elastography data.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start15 Aug 2017
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Dillman, MD,MSc, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260660
- Sponsor's protocol ID
- CIN_CompMRE_001
- Status last verified
- Jan 2018
- First submitted
- 14 Aug 2017
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of MR Elastography Methods Without and With Compressed Sensing
- ClinicalTrials.gov ID
- NCT03260660
- Acronym / sponsor ID
- CIN_CompMRE_001
- Conditions
- Liver Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 24 Aug 2017 (actual)
- 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.
In this research study, the investigators will compare the liver stiffness results obtained from the current Magnetic Resonance Imaging (MRI) method to liver stiffness results obtained from a method that uses faster imaging techniques.
Detailed description
MR elastography is increasingly used to assess liver stiffness in pediatric and adult patients with chronic liver diseases. While numerous tissue abnormalities can affect liver stiffness, liver stiffness measured by MR elastography is most often used to predict and quantify liver fibrosis. Conventional MR elastography techniques require multiple breath-holds that are 12-20 seconds in length. In the pediatric population, reliable breath-holding >10 seconds can be challenging. Recently, compressed sensing has become available as a method for accelerating image data acquisition, and thus shortening breath-holds.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Volunteers
Key inclusion criteria (3 listed)
- Adult volunteers ≥18 years of age
- Ability to tolerate 30 minutes in an MRI scanner.
- Nothing to eat or drink for 4 hours prior to the MRI scan
Key exclusion criteria (2 listed)
- No contraindication to MR imaging (e.g., implanted non-MRI compatible device)
- Known or suspected pregnancy. Female subjects of child bearing potential will undergo a urine pregnancy test prior to imaging.
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 |
|---|---|---|
| Magnetic Resonance ElastographyThe investigators plan to prospectively assess the agreement of liver stiffness measurements obtained using standard of care MR elastography techniques vs. MR elastography with varying amounts of imaging acceleration using compressed sensing in adult volunteers | Device | – |
Primary outcome
Standard Magnetic Resonance Elastography versus Elastography with Compressed Sensing (x1.5)
Time frame: 30 minutes
Four MR elastography images through the mid liver will be obtained using standard MR elastography and MR elastography with 1.5 times the amount of standard Sensing applied. Correlation Coefficient will be determined for resulting elastography data.
Standard Magnetic Resonance Elastography versus Elastography with Compressed Sensing (x2)
Time frame: 30 minutes
Four MR elastography images through the mid liver will be obtained using standard MR elastography and MR elastography with 2 times the amount of standard sensing applied. correlation coefficient will be determined for resulting elastography data.
Standard Magnetic Resonance Elastography versus Elastography with Compressed Sensing (x3)
Time frame: 30 minutes
Four MR elastography images through the mid liver will be obtained using standard MR elastography and MR elastography with 3 times the amount of standard Sensing applied. Correlation coefficient will be determined for resulting elastography data.
2 secondary outcomes
Standard Magnetic Resonance Elastography versus respiratory triggered Magnetic Resonance Elastography.
Time frame: 30 minutes
Standard Magnetic Resonance Elastography versus navigated triggered Magnetic Resonance Elastography.
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Jonathan Dillman, MD,MSc principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 29 Jan 2018. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Standard Magnetic Resonance Elastography versus Elastography with Compressed Sensing (x1.5) (time frame: 30 minutes). The study lists 3 primary outcomes in all. 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 29 Jan 2018.