Liver CirrhosisNCT03623360
Functional MRI to Determine Severity of Cirrhosis
An observational study of Liver Cirrhosis and Liver Fibrosis, run by University of Leeds at 1 site in United Kingdom.
Trial summary
This is a pilot study to investigate the feasibility of a novel MRI technique to assess the severity of liver cirrhosis and predict complications based on functionality and perfusion measurements whilst maintaining image quality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Liver Fibrosis
- What is being tested?
- Free breathing DCE-MRI
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2018to Feb 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cirrhosis who attend the Leeds Liver Unit at St James's University Hospital
Who may be able to join
- Patients who have been diagnosed with liver cirrhosis using standard methods (liver biochemistry, ultrasound based elastography and liver biopsy).
Who cannot join
- Pregnancy
- Allergy/intolerance to Gadolinium based contrast agents
- Severe renal impairment
- Severe respiratory disease
- Inability to undergone MRI due to the presence of metal or electronic implants affected by the magnetic field.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St. James's University Hospital
Leeds, LS9 7LN
Ian Rowe, Dr, 0044 0113 206 5667, i.a.c.rowe@leeds.ac.uk
About this study
Official title: Prediction of Outcomes in Cirrhosis Using Novel Magnetic Resonance Imaging Biomarkers of Liver Function
This is a pilot study to investigate the feasibility of a novel MRI technique to assess the severity of liver cirrhosis and predict complications based on functionality and perfusion measurements whilst maintaining image quality.
The principal objective of this pilot study is to assess liver function and the future risk of complications in patients with cirrhosis, using novel techniques and measures based on free-breathing Dynamic Contrast Enhanced MRI.
Read more
Specifically the investigators will assess:
- Whether sufficient data can be generated in patients with cirrhosis whilst maintaining image quality, and
- The dynamic range of DCE-MRI measures in patients with cirrhosis.
This pilot study will, if successful, provide sufficient data to support applications for larger studies to evaluate the clinical utility of a DCE-MRI imaging biomarker in patients with cirrhosis.
Read the detailed description
This is a pilot study to investigate the feasibility of a novel MRI technique to assess the severity of liver cirrhosis and predict complications based on functionality and perfusion measurements whilst maintaining image quality.
Recruitment:
Twenty (20) patients with cirrhosis who attend the Leeds Liver Unit at St James's University Hospital will be purposively selected by members of the research team who are also part of the usual care team for these patients in advance of scheduled clinic visits. The selection will be in a way to encompass the full clinical spectrum of liver function within cirrhosis.
Scan:
An intravenous cannula will be inserted to the patient's arm by the radiographer, for the automated administration of contrast agent during the scan. The participant will be asked to remain still on his/her back throughout the duration of the scan.
Patients will undergo a full MRI protocol including morphological imaging, fibrosis scoring tests based on relaxometry and diffusion maps, and the novel functional technique.
After the scan:
The participant will not have to attend any extra clinics or scan appointments. The research team (that includes members of the participants ongoing care team) will continue to track the health condition of the participant over a long-term period (5 years) to collect information with regards to clinical events such as hospital admissions, change in treatment, further procedures and death. The clinical follow-up information will be collected as part of routine care through scheduled ongoing outpatient appointments.
The data acquired during the scans will be analysed using a novel method to quantify liver function and the liver images will be reviewed by an expert radiologist to ensure that the quality of these is sufficient for future clinical application. A cross-sectional data analysis will be performed to identify associations between the functional biomarkers and clinical indices for the assessment of liver fibrosis.
- Conditions
- Liver Cirrhosis, Liver Fibrosis
- Being tested
- Free breathing DCE-MRI
- Keywords
- Gadoxetate disodium
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free breathing DCE-MRIDiagnostic test
Free breathing DCE-MRI
| Study group | Role | What they receive |
|---|---|---|
| Patients with liver cirrhosis | The cohort includes patients who encompass the full clinical spectrum of liver function within cirrhosis.
The participants will undergo a full MRI protocol for liver screening including morphological imaging, fibrosis scoring tests based on relaxometry and diffusion maps, and our novel functional technique based on free breathing DCE-MRI. Receives: Diagnostic Test: Free breathing DCE-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image quality
The image quality evaluated visually by an expert radiologist using a scoring system. The score levels for the image quality assessments is: 1: non-diagnostic, 2: poor, 3: adequate, 4: good, and 5: excellent.
Measured: Up to 7 days
The dynamic range of the Total Blood Flow biomarker.
Calculation of the dynamic range of the Total Blood Flow biomarker (ml/100ml/min).
Measured: Up to 7 days
The dynamic range of the Arterial Blood Flow Fraction biomarker.
Calculation of the dynamic range of the Arterial Blood Flow Fraction biomarker (%)
Measured: Up to 7 days
The dynamic range of the Extracellular Volume biomarker.
Calculation of the dynamic range of the Extracellular Volume biomarker (ml/100ml)
Measured: Up to 7 days
The dynamic range of the Intracellular Uptake Rate biomarker.
Calculation of the dynamic range of the Intracellular Uptake Rate biomarker (/100/min)
Measured: Up to 7 days
The dynamic range of the Biliary Excretion Rate biomarker.
Calculation of the dynamic range of the Biliary Excretion Rate biomarker (/100/min)
Measured: Up to 7 days
Secondary outcomes (1)
Correlation of DCE-MRI measures with clinical outcomes
The secondary outcome measure is the correlation between our biomarkers and the clinical scores for the prediction of mortality (Child-Pugh score and the Model to End Stage Liver Disease (MELD)).
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study startSep 2018 (estimated)
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- The Leeds Teaching Hospitals NHS Trust
- Responsible party
- Principal investigator, Ian Rowe, University of Leeds
- Investigators
- Ian Rowe, Dr, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623360
- Sponsor's protocol ID
- IRAS 224109
- Status last verified
- Aug 2018
- First submitted
- 1 Aug 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The information about the health and care of the participants may be provided to researchers running other research studies in this organisation and in other organisations. The information will only be used by organisations and researchers to conduct research in accordance with the United Kingdom Policy Framework for Health and Social Care Research. This information will not identify the individuals and will not be combined with other information in a way that could identify the participants. The images obtained from the MRI scan may also be shared anonymously with Siemens, Inc - the company who have developed the techniques to allow scans to be done without breath holding. These images may be used to improve the way that the scans are processed as well as in illustrations of the quality of the images that can be obtained using this technique.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Outcomes in Cirrhosis Using Novel Magnetic Resonance Imaging Biomarkers of Liver Function
- ClinicalTrials.gov ID
- NCT03623360
- Acronym / sponsor ID
- IRAS 224109
- Conditions
- Liver Cirrhosis, Liver Fibrosis
- Keywords
- Gadoxetate disodium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- The Leeds Teaching Hospitals NHS Trust
- Study start
- Sep 2018 (estimated)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 9 Aug 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.
This is a pilot study to investigate the feasibility of a novel MRI technique to assess the severity of liver cirrhosis and predict complications based on functionality and perfusion measurements whilst maintaining image quality.
The principal objective of this pilot study is to assess liver function and the future risk of complications in patients with cirrhosis, using novel techniques and measures based on free-breathing Dynamic Contrast Enhanced MRI.
Specifically the investigators will assess:
- Whether sufficient data can be generated in patients with cirrhosis whilst maintaining image quality, and
- The dynamic range of DCE-MRI measures in patients with cirrhosis.
This pilot study will, if successful, provide sufficient data to support applications for larger studies to evaluate the clinical utility of a DCE-MRI imaging biomarker in patients with cirrhosis.
Detailed description
This is a pilot study to investigate the feasibility of a novel MRI technique to assess the severity of liver cirrhosis and predict complications based on functionality and perfusion measurements whilst maintaining image quality.
Recruitment:
Twenty (20) patients with cirrhosis who attend the Leeds Liver Unit at St James's University Hospital will be purposively selected by members of the research team who are also part of the usual care team for these patients in advance of scheduled clinic visits. The selection will be in a way to encompass the full clinical spectrum of liver function within cirrhosis.
Scan:
An intravenous cannula will be inserted to the patient's arm by the radiographer, for the automated administration of contrast agent during the scan. The participant will be asked to remain still on his/her back throughout the duration of the scan.
Patients will undergo a full MRI protocol including morphological imaging, fibrosis scoring tests based on relaxometry and diffusion maps, and the novel functional technique.
After the scan:
The participant will not have to attend any extra clinics or scan appointments. The research team (that includes members of the participants ongoing care team) will continue to track the health condition of the participant over a long-term period (5 years) to collect information with regards to clinical events such as hospital admissions, change in treatment, further procedures and death. The clinical follow-up information will be collected as part of routine care through scheduled ongoing outpatient appointments.
The data acquired during the scans will be analysed using a novel method to quantify liver function and the liver images will be reviewed by an expert radiologist to ensure that the quality of these is sufficient for future clinical application. A cross-sectional data analysis will be performed to identify associations between the functional biomarkers and clinical indices for the assessment of liver fibrosis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with liver cirrhosis | – | Diagnostic Test: Free breathing DCE-MRIThe cohort includes patients who encompass the full clinical spectrum of liver function within cirrhosis. The participants will undergo a full MRI protocol for liver screening including morphological imaging, fibrosis scoring tests based on relaxometry and diffusion maps, and our novel functional technique based on free breathing DCE-MRI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cirrhosis who attend the Leeds Liver Unit at St James's University Hospital
Key inclusion criteria (1 listed)
- Patients who have been diagnosed with liver cirrhosis using standard methods (liver biochemistry, ultrasound based elastography and liver biopsy).
Key exclusion criteria (5 listed)
- Pregnancy
- Allergy/intolerance to Gadolinium based contrast agents
- Severe renal impairment
- Severe respiratory disease
- Inability to undergone MRI due to the presence of metal or electronic implants affected by the magnetic field.
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 |
|---|---|---|
| Free breathing DCE-MRIFree breathing DCE-MRI | Diagnostic test | Patients with liver cirrhosis |
Primary outcome
Image quality
Time frame: Up to 7 days
The image quality evaluated visually by an expert radiologist using a scoring system. The score levels for the image quality assessments is: 1: non-diagnostic, 2: poor, 3: adequate, 4: good, and 5: excellent.
The dynamic range of the Total Blood Flow biomarker.
Time frame: Up to 7 days
Calculation of the dynamic range of the Total Blood Flow biomarker (ml/100ml/min).
The dynamic range of the Arterial Blood Flow Fraction biomarker.
Time frame: Up to 7 days
Calculation of the dynamic range of the Arterial Blood Flow Fraction biomarker (%)
The dynamic range of the Extracellular Volume biomarker.
Time frame: Up to 7 days
Calculation of the dynamic range of the Extracellular Volume biomarker (ml/100ml)
The dynamic range of the Intracellular Uptake Rate biomarker.
Time frame: Up to 7 days
Calculation of the dynamic range of the Intracellular Uptake Rate biomarker (/100/min)
The dynamic range of the Biliary Excretion Rate biomarker.
Time frame: Up to 7 days
Calculation of the dynamic range of the Biliary Excretion Rate biomarker (/100/min)
1 secondary outcome
Correlation of DCE-MRI measures with clinical outcomes
Time frame: Up to 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Individual participant dataSharing planned: Undecided. The information about the health and care of the participants may be provided to researchers running other research studies in this organisation and in other organisations. The information will only be used by organisations and researchers to conduct research in accordance with the United Kingdom Policy Framework for Health and Social Care Research. This information will not identify the individuals and will not be combined with other information in a way that could identify the participants. The images obtained from the MRI scan may also be shared anonymously with Siemens, Inc - the company who have developed the techniques to allow scans to be done without breath holding. These images may be used to improve the way that the scans are processed as well as in illustrations of the quality of the images that can be obtained using this technique.
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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.
Ian Rowe, Dr principal investigator
University of Leeds
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 Cirrhosis and Liver Fibrosis, run by University of Leeds at 1 site in United Kingdom.
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 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: status not confirmed, as of the sponsor's last update on 9 Aug 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ian Rowe, Dr (0044 0113 206 5667, i.a.c.rowe@leeds.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image quality (time frame: Up to 7 days). The study lists 6 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 9 Aug 2018.