Liver FibrosesNCT03027700
Methods to Detect Liver Fibrosis
A study testing MRI in people with Liver Fibroses and Hepatic Steatosis, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The goal of this study is to learn more about liver fibrosis and methods to detect it. We will evaluate and compare multiple MRI based measures of liver fibrosis in subjects with and without liver disease. Read more about this study
- Who is it for?
- Ages 8 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Fibroses, Hepatic Steatosis
- What is being tested?
- MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2017to 30 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 8 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Group 1:
- Healthy subjects with no known or suspected liver disease
- Age 8 - 21 years
- Groups 2 and 3:
- Biopsy confirmed liver fibrosis (F1/F2 Group 2, F3/F4 Group 3)
- Age 8 - 21 years
Show all 9Show fewer
- Group 4:
- Biopsy confirmed hepatic steatosis AND biopsy confirmed liver fibrosis (any stage)
- Age 8 - 21 years
Who cannot join
- All subjects:
- Subjects <8 years of age and >21 years of age.
- BMI > 35 kg/m2
- Subjects deemed to possibly require sedation to undergo MR imaging
- Inability to lie still for 90 minutes
- Routine exclusions to MRI - e.g., implanted hardware
Show all 20Show fewer
- Pregnancy (verbal pregnancy screens - per standard practice in Radiology - will be administered to all female participants of child-bearing age at the time of enrollment and again immediately prior to imaging)
- Prior history of liver transplantation
- Group 1
- ALT ≥30 U/L
- Clinical history or lab/biopsy results suggestive of the presence of liver disease including: steatosis, fibrosis, inflammation, tumor, etc.
- Group 2 and 3
- Diagnosis of non-alcoholic fatty liver disease or non-alcoholic steatohepatitis
- Biopsy >6 months prior to research MRI examination
- Initiation of any medications (e.g. steroids, immunosuppressants, antivirals) or procedures (e.g. Kasai portoenterostomy) to treat the liver disease during the time between liver biopsy and study visit
- Group 4
- Biopsy >6 months prior to research MRI examination
- Hepatic fat fraction >5%
- Substantial weight loss (>10% of weight at time of biopsy) during the time between biopsy and study visit
- Initiation of any medications to treat NAFLD (e.g. vitamin E) during the time between biopsy and study visit
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Comparison of Non-invasive Methods to Detect and Quantify Liver Fibrosis
The goal of this study is to learn more about liver fibrosis and methods to detect it. We will evaluate and compare multiple MRI based measures of liver fibrosis in subjects with and without liver disease.
Read the detailed description
While liver biopsy is still considered the gold standard for diagnosing and assessing the presence and degree of liver fibrosis and inflammation, it has disadvantages including the potential for sampling error and risk of complications, including life-threatening bleeding. New imaging modalities such as MR Elastography, T1 mapping, T2 mapping, T1 rho, and magnetization transfer allow rapid, non-invasive evaluation of liver parenchymal characteristics and may be able to detect and quantify parenchymal fibrosis alleviating the need for biopsy. To date, the quantitative performance of these different techniques has not been extensively studied. This study is a single-center trial of non-invasive MR imaging techniques aimed at detecting and measuring liver fibrosis. Once optimized, these technologies may later be deployed in hypothesis driven research studies and/or routine clinical exams in the pediatric population here at CCHMC and/or as part of a multi-center study with specific IRB approval for that project.
To assess the relative performance of each technique, correlation across techniques, and reproducibility across the range of fibrosis, 32 subjects will be enrolled in this preliminary study sub-divided into 4 groups (Group 1: Healthy/ Normal controls; Group 2: F1/F2 fibrosis as determined by prior biopsy (low grade fibrosis group); Group 3: F3/F4 fibrosis as determined by prior biopsy (high grade fibrosis group), Group 4: Hepatic steatosis with fibrosis (NAFLD group)). 8 healthy subjects without known or suspected liver disease will be enrolled as normal controls. 8 subjects each with known fibrosis based on liver biopsy within the last 6 months will be enrolled in Group 2 and Group 3 (total = 16). 8 subjects with known hepatic steatosis and liver fibrosis based on liver biopsy within the last 6 months will be enrolled in Group 4.
- Conditions
- Liver Fibroses, Hepatic Steatosis
- Being tested
- MRI
- Medical subject headings
- Liver Cirrhosis, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
MRI scan performed on 1.5T Philips Ingenia MRI scanner.
| Study group | Role | What they receive |
|---|---|---|
| Health/Normal Controls | Active comparator | Health/normal control subjects will undergo MRI using several different imaging sequences (MR Elastography, T1 mapping, T2 mapping, T1 rho, and magnetization transfer) designed to detect and quantify hepatic fibrosis. Receives: Device: MRI |
| F1/F2 fibrosis | Active comparator | Type 1 and 2 liver fibrosis subjects will undergo MRI using several different imaging sequences (MR Elastography, T1 mapping, T2 mapping, T1 rho, and magnetization transfer) designed to detect and quantify hepatic fibrosis. Receives: Device: MRI |
| F3/F4 fibrosis | Active comparator | Type 2 and 3 liver fibrosis subjects will undergo MRI using several different imaging sequences (MR Elastography, T1 mapping, T2 mapping, T1 rho, and magnetization transfer) designed to detect and quantify hepatic fibrosis. Receives: Device: MRI |
| Hepatic steatosis with fibrosis | Active comparator | Hepatic steatosis with liver fibrosis subjects will undergo MRI using several different imaging sequences (MR Elastography, T1 mapping, T2 mapping, T1 rho, and magnetization transfer) designed to detect and quantify hepatic fibrosis. Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
MR imaging vs. histologic scoring in hepatic fibrosis
Correlate the results from the different imaging sequences designed to detect and quantify hepatic fibrosis
Measured: 2 years
Secondary outcomes (1)
MRI reproducibility
evaluate the reproducibility of each of the tested MRI-based liver fibrosis quantification sequences
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start26 Jan 2017
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Why it stopped: Inadequate recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver FibrosesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027700
- Sponsor's protocol ID
- CIN001- Liver Fibrosis
- Status last verified
- Jan 2020
- First submitted
- 19 Jan 2017
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sporea I, Bota S, Jurchis A, Sirli R, Gradinaru-Tascau O, Popescu A, Ratiu I, Szilaski M. Acoustic radiation force impulse and supersonic shear imaging versus transient elastography for liver fibrosis assessment. Ultrasound Med Biol. 2013 Nov;39(11):1933-41. doi: 10.1016/j.ultrasmedbio.2013.05.003. Epub 2013 Aug 9.
PubMed 23932281Xanthakos SA, Podberesky DJ, Serai SD, Miles L, King EC, Balistreri WF, Kohli R. Use of magnetic resonance elastography to assess hepatic fibrosis in children with chronic liver disease. J Pediatr. 2014 Jan;164(1):186-8. doi: 10.1016/j.jpeds.2013.07.050. Epub 2013 Sep 21.
PubMed 24064151
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Non-invasive Methods to Detect and Quantify Liver Fibrosis
- ClinicalTrials.gov ID
- NCT03027700
- Acronym / sponsor ID
- CIN001- Liver Fibrosis
- Conditions
- Liver Fibroses, Hepatic Steatosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 26 Jan 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 23 Jan 2017 (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 goal of this study is to learn more about liver fibrosis and methods to detect it. We will evaluate and compare multiple MRI based measures of liver fibrosis in subjects with and without liver disease.
Detailed description
While liver biopsy is still considered the gold standard for diagnosing and assessing the presence and degree of liver fibrosis and inflammation, it has disadvantages including the potential for sampling error and risk of complications, including life-threatening bleeding. New imaging modalities such as MR Elastography, T1 mapping, T2 mapping, T1 rho, and magnetization transfer allow rapid, non-invasive evaluation of liver parenchymal characteristics and may be able to detect and quantify parenchymal fibrosis alleviating the need for biopsy. To date, the quantitative performance of these different techniques has not been extensively studied. This study is a single-center trial of non-invasive MR imaging techniques aimed at detecting and measuring liver fibrosis. Once optimized, these technologies may later be deployed in hypothesis driven research studies and/or routine clinical exams in the pediatric population here at CCHMC and/or as part of a multi-center study with specific IRB approval for that project.
To assess the relative performance of each technique, correlation across techniques, and reproducibility across the range of fibrosis, 32 subjects will be enrolled in this preliminary study sub-divided into 4 groups (Group 1: Healthy/ Normal controls; Group 2: F1/F2 fibrosis as determined by prior biopsy (low grade fibrosis group); Group 3: F3/F4 fibrosis as determined by prior biopsy (high grade fibrosis group), Group 4: Hepatic steatosis with fibrosis (NAFLD group)). 8 healthy subjects without known or suspected liver disease will be enrolled as normal controls. 8 subjects each with known fibrosis based on liver biopsy within the last 6 months will be enrolled in Group 2 and Group 3 (total = 16). 8 subjects with known hepatic steatosis and liver fibrosis based on liver biopsy within the last 6 months will be enrolled in Group 4.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Health/Normal Controls | Active comparator | Device: MRIHealth/normal control subjects will undergo MRI using several different imaging sequences (MR Elastography, T1 mapping, T2 mapping, T1 rho, and magnetization transfer) designed to detect and quantify hepatic fibrosis. |
| F1/F2 fibrosis | Active comparator | Device: MRIType 1 and 2 liver fibrosis subjects will undergo MRI using several different imaging sequences (MR Elastography, T1 mapping, T2 mapping, T1 rho, and magnetization transfer) designed to detect and quantify hepatic fibrosis. |
| F3/F4 fibrosis | Active comparator | Device: MRIType 2 and 3 liver fibrosis subjects will undergo MRI using several different imaging sequences (MR Elastography, T1 mapping, T2 mapping, T1 rho, and magnetization transfer) designed to detect and quantify hepatic fibrosis. |
| Hepatic steatosis with fibrosis | Active comparator | Device: MRIHepatic steatosis with liver fibrosis subjects will undergo MRI using several different imaging sequences (MR Elastography, T1 mapping, T2 mapping, T1 rho, and magnetization transfer) designed to detect and quantify hepatic fibrosis. |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Healthy subjects with no known or suspected liver disease
- Age 8 - 21 years
- Biopsy confirmed liver fibrosis (F1/F2 Group 2, F3/F4 Group 3)
- Age 8 - 21 years
- Biopsy confirmed hepatic steatosis AND biopsy confirmed liver fibrosis (any stage)
Key exclusion criteria (20 listed)
- Subjects <8 years of age and >21 years of age.
- BMI > 35 kg/m2
- Subjects deemed to possibly require sedation to undergo MR imaging
- Inability to lie still for 90 minutes
- Routine exclusions to MRI - e.g., implanted hardware
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 |
|---|---|---|
| MRIMRI scan performed on 1.5T Philips Ingenia MRI scanner. | Device | F1/F2 fibrosis, F3/F4 fibrosis, Health/Normal Controls, Hepatic steatosis with fibrosis |
Primary outcome
MR imaging vs. histologic scoring in hepatic fibrosis
Time frame: 2 years
Correlate the results from the different imaging sequences designed to detect and quantify hepatic fibrosis
1 secondary outcome
MRI reproducibility
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Inadequate recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Background: PubMed 23932281Sporea I, Bota S, Jurchis A, Sirli R, Gradinaru-Tascau O, Popescu A, Ratiu I, Szilaski M. Acoustic radiation force impulse and supersonic shear imaging versus transient elastography for liver fibrosis assessment. Ultrasound Med Biol. 2013 Nov;39(11):1933-41. doi: 10.1016/j.ultrasmedbio.2013.05.003. Epub 2013 Aug 9.
- Background: PubMed 24064151Xanthakos SA, Podberesky DJ, Serai SD, Miles L, King EC, Balistreri WF, Kohli R. Use of magnetic resonance elastography to assess hepatic fibrosis in children with chronic liver disease. J Pediatr. 2014 Jan;164(1):186-8. doi: 10.1016/j.jpeds.2013.07.050. Epub 2013 Sep 21.
- Individual participant dataSharing planned: No
Related trials for Liver Fibroses
Not yet recruitingObservational study
A Study of Fatigue, Itching and Daily Activities in People With Primary Biliary Cholangitis Starting Elafibranor
Primary Biliary Cholangitis (PBC)
RecruitingPhase 3
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
Primary Biliary Cirrhosis
RecruitingPhase 2/3
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cholangitis
Active, not recruitingObservational study
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia
Enrolling by invitationPhase 2/3
A Multicenter, Randomized, Controlled Trial of Prednisone Combined With Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis With Moderate to Severe Interface Hepatitis Characteristics
Primary Biliary Cholangitis (PBC)
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 in people with Liver Fibroses and Hepatic Steatosis, 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 9 inclusion and 20 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 29 Jan 2020. 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 was stopped early (reason given: Inadequate recruitment). 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?
MR imaging vs. histologic scoring in hepatic fibrosis (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03027700, which also lists 2 linked publications.
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 2020.