Non-alcoholic Fatty Liver DiseaseNCT02461212
Validation of HepaFat-Scan for Noninvasive Measurement of Steatosis in Youth
A study testing Magnetic Resonance Imaging (MRI) in people with Non-alcoholic Fatty Liver Disease, run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to see if the HepaFat-Scan (a special sequence of images done in a MRI) can accurately detect the amount of fat in the liver. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- Magnetic Resonance Imaging (MRI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2015to 17 Mar 2017
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Boys and girls age 7-18 years
- Scheduled for a clinically indicated liver biopsy
- Able to undergo MRI without sedation
- Written informed consent from parent or legal guardian
- Written informed assent from the child when indicated by age
Who cannot join
- Renal disease with a creatinine > 2 or requiring dialysis
- Metal, braces or other implanted devices not compatible with MRI
- Not willing to try to hold still for an un-sedated MRI
- Pregnancy
- Failure to give consent or assent
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322
About this study
The purpose of this study is to see if the HepaFat-Scan (a special sequence of images done in a MRI) can accurately detect the amount of fat in the liver.
Read the detailed description
The leading cause of liver disease for both adults and children in the US is nonalcoholic fatty liver disease (NAFLD), an obesity-related liver disease closely associated with the metabolic syndrome. NAFLD increases the risk of liver disease but also increases risk of type II diabetes, cardiovascular disease (CVD) and the metabolic syndrome. Invasive liver biopsy has been considered the best diagnostic tool for confirming NAFLD. This study will establish magnetic resonance imaging (MRI) / magnetic resonance spectroscopy (MRS) as a quantitative noninvasive "virtual biopsy" and benefit the health of children with liver diseases by decreasing risk and improving diagnosis. Specifically, in NAFLD, this fat quantification protocol will be broadly useful in future research studies, including therapies for NAFLD as well as for patient diagnosis and follow-up.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- Magnetic Resonance Imaging (MRI)
- Keywords
- HepaFat-Scan, Liver Disease, Pediatrics
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Procedure or surgery
A MRI scan which will include magnetic resonance spectroscopy (MRS) of the liver to determine hepatic triglyceride content, a hepafat scan to measure volume fraction of fat in liver tissue, and a MRI for detection of liver fibrosis. The scan will last approximately 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Liver MRI | Experimental | Liver MRI imaging will be performed on subjects undergoing a liver biopsy Receives: Procedure: Magnetic Resonance Imaging (MRI) |
| Liver MRI repositioned | Experimental | Liver MRI imaging will be performed on subjects undergoing a liver biopsy and then they will be repositioned and will repeat the MRI Receives: Procedure: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between HepaFat-Scan and pathology based assessment of steatosis
Correlation of histologic steatosis to HepaFat-Scan measurement.
Measured: 12 months
Correlation of HepaFat-Scan measurement with magnetic resonance spectroscopy (MRS) and computerized steatosis
The percent of total steatosis by MRS and computerized steatosis (computer-assisted pixel count algorithm) will be plotted and Pearson correlation coefficient will be calculated to explore their relationship.
Measured: 12 months
Correlation of HepaFat-Scan measurement with magnetic resonance spectroscopy (MRS) and grade of pathology of assessment
The percent steatosis from the MRS and grade of pathology of assessment will be plotted and compared to categorization using HepaFat-Scan.
Measured: 12 months
Repeatability of HepaFat-Scan
Two HepaFat-Scans will be done on half of the subjects. Repeatability of the Hepafat scan will be assessed.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study start1 Jul 2015
- Primary completion17 Mar 2017
- Study completion17 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Resonance Health
- Responsible party
- Principal investigator, Miriam Vos, MD, Emory University
- Investigators
- Miriam B Vos, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02461212
- Sponsor's protocol ID
- IRB00078470
- Status last verified
- Apr 2017
- First submitted
- 1 Jun 2015
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of HepaFat-Scan for Noninvasive Measurement of Steatosis in Youth
- ClinicalTrials.gov ID
- NCT02461212
- Acronym / sponsor ID
- IRB00078470
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- HepaFat-Scan, Liver Disease, Pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Resonance Health
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 17 Mar 2017 (actual)
- Study completion
- 17 Mar 2017 (actual)
- First posted
- 3 Jun 2015 (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 see if the HepaFat-Scan (a special sequence of images done in a MRI) can accurately detect the amount of fat in the liver.
Detailed description
The leading cause of liver disease for both adults and children in the US is nonalcoholic fatty liver disease (NAFLD), an obesity-related liver disease closely associated with the metabolic syndrome. NAFLD increases the risk of liver disease but also increases risk of type II diabetes, cardiovascular disease (CVD) and the metabolic syndrome. Invasive liver biopsy has been considered the best diagnostic tool for confirming NAFLD. This study will establish magnetic resonance imaging (MRI) / magnetic resonance spectroscopy (MRS) as a quantitative noninvasive "virtual biopsy" and benefit the health of children with liver diseases by decreasing risk and improving diagnosis. Specifically, in NAFLD, this fat quantification protocol will be broadly useful in future research studies, including therapies for NAFLD as well as for patient diagnosis and follow-up.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liver MRI | Experimental | Procedure: Magnetic Resonance Imaging (MRI)Liver MRI imaging will be performed on subjects undergoing a liver biopsy |
| Liver MRI repositioned | Experimental | Procedure: Magnetic Resonance Imaging (MRI)Liver MRI imaging will be performed on subjects undergoing a liver biopsy and then they will be repositioned and will repeat the MRI |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Boys and girls age 7-18 years
- Scheduled for a clinically indicated liver biopsy
- Able to undergo MRI without sedation
- Written informed consent from parent or legal guardian
- Written informed assent from the child when indicated by age
Key exclusion criteria (5 listed)
- Renal disease with a creatinine > 2 or requiring dialysis
- Metal, braces or other implanted devices not compatible with MRI
- Not willing to try to hold still for an un-sedated MRI
- Pregnancy
- Failure to give consent or assent
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 Imaging (MRI)A MRI scan which will include magnetic resonance spectroscopy (MRS) of the liver to determine hepatic triglyceride content, a hepafat scan to measure volume fraction of fat in liver tissue, and a MRI for detection of liver fibrosis. The scan will last approximately 15 minutes. | Procedure or surgery | Liver MRI, Liver MRI repositioned |
Primary outcome
Correlation between HepaFat-Scan and pathology based assessment of steatosis
Time frame: 12 months
Correlation of histologic steatosis to HepaFat-Scan measurement.
Correlation of HepaFat-Scan measurement with magnetic resonance spectroscopy (MRS) and computerized steatosis
Time frame: 12 months
The percent of total steatosis by MRS and computerized steatosis (computer-assisted pixel count algorithm) will be plotted and Pearson correlation coefficient will be calculated to explore their relationship.
Correlation of HepaFat-Scan measurement with magnetic resonance spectroscopy (MRS) and grade of pathology of assessment
Time frame: 12 months
The percent steatosis from the MRS and grade of pathology of assessment will be plotted and compared to categorization using HepaFat-Scan.
Repeatability of HepaFat-Scan
Time frame: 12 months
Two HepaFat-Scans will be done on half of the subjects. Repeatability of the Hepafat scan will be assessed.
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 10 Apr 2017.
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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.
Miriam B Vos, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging (MRI) in people with Non-alcoholic Fatty Liver Disease, run by Emory University 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 5 inclusion and 5 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 10 Apr 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 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?
Correlation between HepaFat-Scan and pathology based assessment of steatosis (time frame: 12 months). The study lists 4 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 10 Apr 2017.