Liver FibrosisNCT03539757
Development of Novel MRI Methods for Detecting, Discriminating, and Measuring Liver Fibrosis and Congestion in Fontan Patients
An observational study of Liver Fibrosis, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
In this research study, the investigators will conduct a prospective cross-sectional study of pediatric and adult Fontan patients that will correlate a variety of quantitative MRI biomarkers with histopathologic data. Read more about this study
- Who is it for?
- Ages 8 to 99 years
- Conditions the study is for
- Liver Fibrosis
- What is being tested?
- Non-Contrast Magnetic Resonance Imaging
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2018to 30 Mar 2022
- 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 8 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Eligible subjects will be identified through Cincinnati Children's Hospital Medical Center's (CCHMC) cardiology or hepatology clinics, or through CCHMCs Fontan Management Program
Who may be able to join
- Single ventricle physiology congenital heart disease status post Fontan palliation
- Undergoing clinically-indicated liver biopsy
- Ability to tolerate 60 minutes in an MRI scanner without sedation
Who cannot join
- Known contraindication to MR imaging (e.g., implanted non-MRI compatible device)
- Known or suspected pregnancy. Female subjects of child bearing potential will undergo urine pregnancy testing 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 conduct a prospective cross-sectional study of pediatric and adult Fontan patients that will correlate a variety of quantitative MRI biomarkers with histopathologic data.
Read the detailed description
The purpose of this study is to develop noninvasive MRI methods for detecting, discriminating, and measuring liver fibrosis and congestion in the adolescent and adult Fontan population by correlating quantitative imaging measurements with histopathologic data, using a cross-sectional approach.
Over 5 years, approximately 40 pediatric and adult subjects (approximately 8 subjects per year) undergoing clinically-indicated liver biopsy for the evaluation of either 1) focal liver lesions/masses, or 2) suspected liver fibrosis/parenchymal disease will be recruited to participate in this study. Subjects will undergo research MR imaging within ±2 weeks of the liver biopsy procedure. A variety of MRI biomarkers will be correlated with histopathologic data obtained from the clinically indicated liver biopsy.
- Conditions
- Liver Fibrosis
- Being tested
- Non-Contrast Magnetic Resonance Imaging
- Keywords
- Liver fibrosis, Fontan surgery, MRI, Novel Methods
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Contrast Magnetic Resonance ImagingDevice
The investigators plan to prospectively assess the correlation of liver fibrosis and congestion measurements obtained from novel, non-contrast MR imaging methods to histopathologic data obtained from a clinically-indicated liver biopsy in Fontan patients.
| Study group | Role | What they receive |
|---|---|---|
| Fontan patients | Pediatric and adult Fontan patients will undergo MRI (Magnetic Resonance Imaging) of the liver using novel, non-contrast MRI methods. These MR methods will be used to detect, discriminate and measure liver fibrosis and congestion. The resulting quantitative imaging measurements will be correlated with histopathologic data obtained from a clinically-indicated liver biopsy. Receives: Device: Non-Contrast Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
MR elastography data correlation to histologic data
MR elastography of the liver data will be correlated with histopathologic data obtained from non-lesional liver tissue. Histologic fibrosis and congestion will be scored by a pathologist using semi-quantitative grading systems (e.g., METAVIR scoring system for fibrosis
Measured: 60 minutes
Secondary outcomes (4)
MR T1 mapping data (corrected and uncorrected) correlation to histologic data
MR T1 mapping liver data (corrected and uncorrected) will be correlated with histopathologic data obtained from non-lesional liver tissue. Histologic fibrosis and congestion will be scored by a pathologist using semi-quantitative grading systems (e.g., METAVIR scoring system for fibrosis)
Measured: 60 minutes
MR T1rho data correlation to histologic data
MR T1rho liver data will be correlated with histopathologic data obtained from non-lesional liver tissue. Histologic fibrosis and congestion will be scored by a pathologist using semi-quantitative grading systems (e.g., METAVIR scoring system for fibrosis)
Measured: 60 minutes
MR T2 mapping data correlation to histologic data
MR T2 mapping liver data will be correlated with histopathologic data obtained from non-lesional liver tissue. Histologic fibrosis and congestion will be scored by a pathologist using semi-quantitative grading systems (e.g., METAVIR scoring system for fibrosis)
Measured: 60 minutes
MR Diffusion weighted data correlation to histologic data
MR Diffusion weighted liver data will be correlated with histopathologic data obtained from non-lesional liver tissue. Histologic fibrosis and congestion will be scored by a pathologist using semi-quantitative grading systems (e.g., METAVIR scoring system for fibrosis)
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start9 May 2018
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Why it stopped: Due to lack of enrollment this study was permanatly closed March 2022. The incidence of FONTAN patients being referred for liver biospsies and occurance of COVID effected participants enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 6 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
- NCT03539757
- Sponsor's protocol ID
- CIN_FALD MRI
- Status last verified
- Jun 2021
- First submitted
- 16 May 2018
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Novel MRI Methods for Detecting, Discriminating, and Measuring Liver Fibrosis and Congestion in Fontan Patients
- ClinicalTrials.gov ID
- NCT03539757
- Acronym / sponsor ID
- CIN_FALD MRI
- Conditions
- Liver Fibrosis
- Keywords
- Liver fibrosis, Fontan surgery, MRI, Novel Methods
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to lack of enrollment this study was permanatly closed March 2022. The incidence of FONTAN patients being referred for liver biospsies and occurance of COVID effected participants enrolled.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 9 May 2018 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 29 May 2018 (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 conduct a prospective cross-sectional study of pediatric and adult Fontan patients that will correlate a variety of quantitative MRI biomarkers with histopathologic data.
Detailed description
The purpose of this study is to develop noninvasive MRI methods for detecting, discriminating, and measuring liver fibrosis and congestion in the adolescent and adult Fontan population by correlating quantitative imaging measurements with histopathologic data, using a cross-sectional approach.
Over 5 years, approximately 40 pediatric and adult subjects (approximately 8 subjects per year) undergoing clinically-indicated liver biopsy for the evaluation of either 1) focal liver lesions/masses, or 2) suspected liver fibrosis/parenchymal disease will be recruited to participate in this study. Subjects will undergo research MR imaging within ±2 weeks of the liver biopsy procedure. A variety of MRI biomarkers will be correlated with histopathologic data obtained from the clinically indicated liver biopsy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fontan patients | – | Device: Non-Contrast Magnetic Resonance ImagingPediatric and adult Fontan patients will undergo MRI (Magnetic Resonance Imaging) of the liver using novel, non-contrast MRI methods. These MR methods will be used to detect, discriminate and measure liver fibrosis and congestion. The resulting quantitative imaging measurements will be correlated with histopathologic data obtained from a clinically-indicated liver biopsy. |
Who may qualify
- Ages
- 8 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Eligible subjects will be identified through Cincinnati Children's Hospital Medical Center's (CCHMC) cardiology or hepatology clinics, or through CCHMCs Fontan Management Program
Key inclusion criteria (3 listed)
- Single ventricle physiology congenital heart disease status post Fontan palliation
- Undergoing clinically-indicated liver biopsy
- Ability to tolerate 60 minutes in an MRI scanner without sedation
Key exclusion criteria (2 listed)
- Known contraindication to MR imaging (e.g., implanted non-MRI compatible device)
- Known or suspected pregnancy. Female subjects of child bearing potential will undergo urine pregnancy testing 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 |
|---|---|---|
| Non-Contrast Magnetic Resonance ImagingThe investigators plan to prospectively assess the correlation of liver fibrosis and congestion measurements obtained from novel, non-contrast MR imaging methods to histopathologic data obtained from a clinically-indicated liver biopsy in Fontan patients. | Device | Fontan patients |
Primary outcome
MR elastography data correlation to histologic data
Time frame: 60 minutes
MR elastography of the liver data will be correlated with histopathologic data obtained from non-lesional liver tissue. Histologic fibrosis and congestion will be scored by a pathologist using semi-quantitative grading systems (e.g., METAVIR scoring system for fibrosis
4 secondary outcomes
MR T1 mapping data (corrected and uncorrected) correlation to histologic data
Time frame: 60 minutes
MR T1rho data correlation to histologic data
Time frame: 60 minutes
MR T2 mapping data correlation to histologic data
Time frame: 60 minutes
MR Diffusion weighted data correlation to histologic data
Time frame: 60 minutes
Results and safety
The study was stopped early (reason given: Due to lack of enrollment this study was permanatly closed March 2022. The incidence of FONTAN patients being referred for liver biospsies and occurance of COVID effected participants enrolled.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- 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 Fibrosis, 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: stopped early, as of the sponsor's last update on 7 Mar 2024. 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: Due to lack of enrollment this study was permanatly closed March 2022. The incidence of FONTAN patients being referred for liver biospsies and occurance of COVID effected participants enrolled.). 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 elastography data correlation to histologic data (time frame: 60 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 7 Mar 2024.