Phase 4
N=276
Detection of Liver Fibrosis With Magnetic Resonance Imaging (MRI)
Chronic Liver Disease
Bottom Line
View on ClinicalTrials.gov: NCT01600105 ↗Enrolled (actual)
276
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: PV Flow — 16.0; 15.5; 23.2; 27.1 ml/s
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Perfusion MRI (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bachir Taouli
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PV Flow |
16.0; 15.5; 23.2; 27.1 | — |
| PRIMARY PV Velocity |
10.5; 11.5; 12.8; 14.4 | — |
| PRIMARY LS-MRE for Sub-Study I |
4.9; 1.8; 5.0; 2.0 | — |
| PRIMARY True Diffusion Parameter (D) |
1.06; 0.94 | — |
| PRIMARY LS-MRE Fibrosis State for Sub Study II |
2.88; 5.16 | — |
| PRIMARY LS-TE |
9.55; 21.44 | — |
| PRIMARY MTT |
11.6; 18.8 | — |
| SECONDARY Liver Upslope From DCE-MRI |
0.011; 0.0007; 0.011; 0.0006 | — |
| SECONDARY Liver Time to Peak (TTP) for PH |
40.99; 53.02; 41.47; 69.45 | — |
| SECONDARY LS-MRE Portal Hypertension for Sub Study III |
2.31; 5.14; 3.88; 5.86 | — |
| SECONDARY Spleen Volume |
246; 441 | — |
| SECONDARY Spleen Caudocranial Diameter |
11.6; 14.0 | — |
| SECONDARY PH Imaging Score |
0; 2; 1; 4 | — |
| SECONDARY LSLU |
192.72; 830.28; 363.68; 871.82 | — |
| SECONDARY Liver DV |
47.28; 77.25 | — |
| SECONDARY Spleen TTP |
15.46; 44.90 | — |
Summary
Patients with chronic liver disease are at high risk of developing liver scarring (fibrosis), with ultimate risks of cirrhosis and liver cancer that may require liver transplant. The investigators would like to develop non invasive advanced Magnetic Resonance Imaging (MRI) techniques (MR diffusion, perfusion and elastography) to assess the degree of liver damage in patients with chronic liver disease. These techniques combined could reach high diagnostic performance for detection of liver fibrosis; and could decrease the number of liver biopsies, which have risks and sample only a small portion of the liver.
Eligibility Criteria
Inclusion Criteria
- Chronic liver disease (including viral hepatitis, alcoholic hepatitis, non alcoholic steatohepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, etc..)
- 18 years of age and older
- Liver biopsy (percutaneous or transjugular or surgical) performed within 6 months, as part of routine clinical care.
- Liver transplant or liver resection performed within 6 months, as part of routine clinical care.
- Patient is able to give informed consent for this study and agrees to provide a blood sample
Control group
- Patients without history of liver disease and healthy volunteers
- 18 years of age and older
- Subject is able to give informed consent for this study and agrees to provide a blood sample
Exclusion Criteria
- Age less than 18 years
- Unable or unwilling to give informed consent
- Contra-indications to MRI
- Electrical implants such as cardiac pacemakers or perfusion pumps
- Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
- Ferromagnetic objects such as jewelry or metal clips in clothing
- Pregnant subjects
- Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions.
Data sourced from ClinicalTrials.gov (NCT01600105). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.