Liver FibrosisIVIM-MRINCT03173287
Quantification of Hepatic Fibrosis by IVIM Sequences in 1.5T MRI
A study testing Quantification of liver fibrosis in people with Liver Fibrosis and MRI, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Quantification of hepatic fibrosis by IVIM sequences in 1.5T MRI. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Liver Fibrosis, MRI, IVIM
- What is being tested?
- Quantification of liver fibrosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2017to Nov 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing hepatic biopsy (trans-parietal or trans-jugular) in the context of liver disease
- Signature of written consent
Who cannot join
- Contra-indications to MRI
- Refusal of protocol
- Underage patients and protected adults
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, Auvergne, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Benoit MAGNIN
About this study
Official title: Quantification of Hepatic Fibrosis by IVIM Sequences in 1.5T MRI.
Quantification of hepatic fibrosis by IVIM sequences in 1.5T MRI.
Read the detailed description
Early and accurate diagnosis of hepatic fibrosis in patients with chronic liver disease is essential and essential. This assessment could be performed by a non-invasive MRI method.
The main objective of this study is to show that the measured perfusion-related scattering value (D *) is related to the hepatic fibrosis stage.
Secondary objectives
- Evaluation of infusion fraction (f) and fibrosis stage.
- Evaluation of molecular diffusion (D) and fibrosis stage.
- Evaluation of ADC and fibrosis stage.
- Assess whether there is a link between the etiology of fibrosis and the value of the diffusion.
- Conditions
- Liver Fibrosis, MRI, IVIM, Liver Biopsy
- Being tested
- Quantification of liver fibrosis
- Keywords
- Hepatic fibrosis, IVIM, 1.5T MRI
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantification of liver fibrosisProcedure or surgery
Procedure MRI and liver biopsy
| Study group | Role | What they receive |
|---|---|---|
| Patients with hepatic biopsy | Experimental | The patients having benefited from a hepatic biopsy for evaluation of the hepatic fibrosis, will benefit in 10 days of a MRI in the service of radiology of the hospital Gabriel Montpied. Receives: Procedure: Quantification of liver fibrosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measured perfusion-related scattering value
The main objective of this study is to show that the measured perfusion-related scattering value (D *) is related to the hepatic fibrosis stage.
Measured: at day 1
Secondary outcomes (3)
Measured perfusion-related of infusion fraction
Measured: at day 1
Measured perfusion-related of molecular diffusion
Measured: at day 1
Measured perfusion-related of ADC
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start1 Mar 2017
- Primary completion1 Mar 2017
- Study completionNov 2018 (estimated)
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 University Hospital, Clermont-FerrandThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoit MAGNIN, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173287
- Sponsor's protocol ID
- CHU-327
- Other IDs
- 2016-A02066-45
- Acronym
- IVIM-MRI
- Status last verified
- May 2017
- First submitted
- 9 May 2017
- Last updated
- 1 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Hepatic Fibrosis by IVIM Sequences in 1.5T MRI.
- ClinicalTrials.gov ID
- NCT03173287
- Acronym / sponsor ID
- IVIM-MRI / CHU-327
- Conditions
- Liver Fibrosis, MRI, IVIM, Liver Biopsy
- Keywords
- Hepatic fibrosis, IVIM, 1.5T MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- Nov 2018 (estimated)
- First posted
- 1 Jun 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.
Quantification of hepatic fibrosis by IVIM sequences in 1.5T MRI.
Detailed description
Early and accurate diagnosis of hepatic fibrosis in patients with chronic liver disease is essential and essential. This assessment could be performed by a non-invasive MRI method.
The main objective of this study is to show that the measured perfusion-related scattering value (D *) is related to the hepatic fibrosis stage.
Secondary objectives
- Evaluation of infusion fraction (f) and fibrosis stage.
- Evaluation of molecular diffusion (D) and fibrosis stage.
- Evaluation of ADC and fibrosis stage.
- Assess whether there is a link between the etiology of fibrosis and the value of the diffusion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with hepatic biopsy | Experimental | Procedure: Quantification of liver fibrosisThe patients having benefited from a hepatic biopsy for evaluation of the hepatic fibrosis, will benefit in 10 days of a MRI in the service of radiology of the hospital Gabriel Montpied. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing hepatic biopsy (trans-parietal or trans-jugular) in the context of liver disease
- Signature of written consent
Key exclusion criteria (3 listed)
- Contra-indications to MRI
- Refusal of protocol
- Underage patients and protected adults
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 |
|---|---|---|
| Quantification of liver fibrosisProcedure MRI and liver biopsy | Procedure or surgery | Patients with hepatic biopsy |
Primary outcome
Measured perfusion-related scattering value
Time frame: at day 1
The main objective of this study is to show that the measured perfusion-related scattering value (D *) is related to the hepatic fibrosis stage.
3 secondary outcomes
Measured perfusion-related of infusion fraction
Time frame: at day 1
Measured perfusion-related of molecular diffusion
Time frame: at day 1
Measured perfusion-related of ADC
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 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.
Benoit MAGNIN principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantification of liver fibrosis in people with Liver Fibrosis and MRI, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 2 inclusion and 3 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 1 Jun 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 France. 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 Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measured perfusion-related scattering value (time frame: at day 1). 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 1 Jun 2017.