Detection of Liver Fibrosis With Magnetic Resonance Imaging (MRI)

Browse trials for

• Liver Diseases 2,081
• Liver Cirrhosis 1,642
• Fibrosis 3,255

Keywords

• liver fibrosis
• liver cirrhosis
• chronic hepatitis
• magnetic resonance imaging

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 276 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Lead sponsor

This is the only study on the registry with Bachir Taouli as lead sponsor.

Study arms

• Experimental
  Perfusion MRI

  chronic liver disease who underwent/will undergo liver biopsy or will undergo liver transplant or liver resection as part of standard care during the previous 6 months.

  Drug: Perfusion MRI

Interventions

• DrugPerfusion MRI

  1) Assess the role of a new FDA approved blood pool gadolinium contrast agent (gadofosveset trisodium, Ablavar, Lantheus) for the measurement of liver MR Perfusion, compared to extra-cellular contrast agents.

  Also known as: Dynamic contrast-enhanced MRI, Perfusion MRI (adofosveset trisodium, Ablavar, Lantheus)

Primary outcomes

1. PV Flow

   Sub-Study I Portal Venous Flow - forward flow during systole and early diastole, and flow reversal after atrial contraction.The average PV area was extracted, and PV flow was computed as the multiplication of area and velocity.

   Time frame: Fasting State Scan (an average of 15 min) and Postprandial State Scan (an average of 15 min)

2. PV Velocity

   Sub-Study I Portal Venous Flow Velocity - The mean velocity of the region of interest (ROI) was extracted for each one of the 25 phase images, and the time average was computed.

   Time frame: Fasting State Scan (an average of 15 min) and Postprandial State Scan (an average of 15 min)

3. LS-MRE for Sub-Study I

   Sub-Study I Liver stiffness (LS) measured by magnetic resonance elastography (MRE) in kilopascal (kPa). Liver stiffness is assessed by mathematical modeling of compression waves propagation in the liver, as measured from MRE images.

   Time frame: Fasting State Scan (an average of 15 min) and Postprandial State Scan (an average of 15 min)

4. True Diffusion Parameter (D)

   Sub-Study II True Diffusion Parameter - D- describes water diffusion in tissue independently from the effects of capillary perfusion; it is obtained from bi-exponential fitting of MRI diffusion signal acquired over a range of high and low diffusion-weighting factors (b-values) Fibrosis State/Score: F0-F2 - no signs of fibrosis to minimal fibrosis F3-F4 - fibrosis has spread and has connected to other areas on the liver that contain fibrosis or presence of cirrhosis

   Time frame: Fasting State Multiparametric MRI Scan (an average of 60 min) Scan

5. LS-MRE Fibrosis State for Sub Study II

   Sub-Study II Liver stiffness (LS) measured by magnetic resonance elastography (MRE) in kilopascal (kPa). Liver stiffness is assessed by mathematical modeling of compression waves propagation in the liver, as measured from MRE images. Fibrosis State/Score: F0-F2 - no signs of fibrosis to minimal fibrosis F3-F4 - fibrosis has spread and has connected to other areas on the liver that contain fibrosis or presence of cirrhosis

   Time frame: Fasting State Multiparametric MRI Scan (an average of 60 min)

6. LS-TE

   Sub-Study II Liver Stiffness with transient elastography (TE) (LS-TE) - a non-invasive modality of liver fibrosis detection: a shear wave is sent into the liver through a small transducer attached to an ultrasound probe, and the velocity of the wave is measured as it passes through the liver; shear wave velocity is then converted to stiffness, measured in kilopascals (kPa) Fibrosis State/Score: F0-F2 - no signs of fibrosis to minimal fibrosis F3-F4 - fibrosis has spread and has connected to other areas on the liver that contain fibrosis or presence of cirrhosis

   Time frame: Fasting transient elastography, average duration 10 min

7. MTT

   Sub-Study II Mean Transit Time (MTT) - Liver Mean Transit Time of Contrast Agent through the tissue of interest from Dynamic Contrast Enhanced MRI Fibrosis State/Score: F0-F2 - no signs of fibrosis to minimal fibrosis F3-F4 - fibrosis has spread and has connected to other areas on the liver that contain fibrosis or presence of cirrhosis

   Time frame: Fasting State Multiparametric MRI Scan (an average of 60 min)

Secondary outcomes

1. Liver Upslope From DCE-MRI

   Sub-Study III Liver Upslope of MRI signal is defined as peak concentration to the time to reach peak concentration of gadolinium contrast agent in the liver tissue of interest, derived from dynamic contrast-enhanced MRI (DCE-MRI. Portal hypertension (PH), defined by hepatic venous pressure gradient (HVPG) ≥5 mmHg Clinically Significant Portal hypertension (CSPH), defined by hepatic venous pressure gradient (HVPG) ≥10 mmHg

   Time frame: Fasting State Multiparametric MRI Scan (an average of 60 min)

2. Liver Time to Peak (TTP) for PH

   Sub-Study III Liver Time to Peak (TTP) is defined as the time in seconds to reach peak concentration of gadolinium contrast agent in the liver tissue of interest, derived from dynamic contrast-enhanced MRI (DCE-MRI) Portal hypertension (PH), defined by hepatic venous pressure gradient (HVPG) ≥5 mmHg Clinically Significant Portal Hypertension is defined as an HVPG ≥10 mmHg

   Time frame: Fasting State Multiparametric MRI Scan (an average of 60 min)

3. LS-MRE Portal Hypertension for Sub Study III

   Sub-Study III Liver stiffness (LS) measured by magnetic resonance elastography (MRE) in kilopascal (kPa). Liver stiffness is assessed by mathematical modeling of compression waves propagation in the liver, as measured from MRE images. Portal Hypertension is defined as an HVPG ≥5 mmHg Clinically Significant Portal hypertension (CSPH), defined by hepatic venous pressure gradient (HVPG) ≥10 mmHg

   Time frame: Fasting State Multiparametric MRI Scan (an average of 60 min)

4. Spleen Volume

   Sub-Study III Portal Hypertension is defined as an HVPG ≥5 mmHg

   Time frame: Fasting State Multiparametric MRI Scan (an average of 60 min)

5. Spleen Caudocranial Diameter

   Sub-Study III Portal Hypertension is defined as an HVPG ≥5 mmHg

   Time frame: Fasting State Multiparametric MRI Scan (an average of 60 min)

6. PH Imaging Score

   Sub-Study III Portal Hypertension imaging composite score (based on the presence of varices, spleen size, presence of ascites). The imaging score is based on the number of variceal sites (0: absence of varices, 1: one variceal site, 2: two variceal sites, and 3: 3 or more variceal sites), volume of ascites (0: no ascites, 1: minimal perihepatic and perisplenic fluid, 2: intraperitoneal fluid without marked abdominal wall distension, and 3: fluid causing marked abdominal wall distension), and maximum craniocaudal diameter of the spleen (0: size less than 13 cm, 1: size between 13 and 15 cm, 2: size between 15 and 20 cm, and 3: size greater than 20 cm). Score from 0 to 9, with higher score indicating worse disease. Portal Hypertension is defined as an HVPG ≥5 mmHg Clinically Significant Portal hypertension (CSPH), defined by hepatic venous pressure gradient (HVPG) ≥10 mmHg

   Time frame: Fasting State Multiparametric MRI Scan (an average of 60 min)

7. LSLU

   Sub-Study III Liver Stiffness to Liver Upslope ratio (LSLU) Portal Hypertension is defined as an HVPG ≥5 mmHg Clinically Significant Portal hypertension (CSPH), defined by hepatic venous pressure gradient (HVPG) ≥10 mmHg

   Time frame: Fasting State Multiparametric MRI Scan (an average of 60 min)

8. Liver DV

   Sub Study III Liver Distribution Volume (DV) is the distribution volume of contrast agent in the tissue of interest defined as a percentage ratio of gadolinium material volume to the volume of the liver tissue of interest, as derived from DCE-MRI; in the case of a contrast agent with extracellular distribution, DV measures the intravascular and extravascular-extracellular volume. Clinically Significant Portal hypertension (CSPH), defined by hepatic venous pressure gradient (HVPG) ≥10 mmHg

   Time frame: Fasting State Multiparametric MRI Scan (an average of 60 min)

9. Spleen TTP

   Sub Study III Spleen Time To Peak (TTP) - time to reach peak gadolinium concentration in spleen tissue of interest, derived from DCE-MRI. Clinically Significant Portal hypertension (CSPH), defined by hepatic venous pressure gradient (HVPG) ≥10 mmHg

   Time frame: Fasting State Multiparametric MRI Scan (an average of 60 min)

Baseline characteristics

5 further baseline measures are reported on the registry.

Publications

• Jajamovich GH, Dyvorne H, Donnerhack C, Taouli B. Quantitative liver MRI combining phase contrast imaging, elastography, and DWI: assessment of reproducibility and postprandial effect at 3.0 T. PLoS One. 2014 May 19;9(5):e97355. doi: 10.1371/journal.pone.0097355. eCollection 2014. PubMed 24840288 ↗
• Dyvorne HA, Jajamovich GH, Bane O, Fiel MI, Chou H, Schiano TD, Dieterich D, Babb JS, Friedman SL, Taouli B. Prospective comparison of magnetic resonance imaging to transient elastography and serum markers for liver fibrosis detection. Liver Int. 2016 May;36(5):659-66. doi: 10.1111/liv.13058. Epub 2016 Feb 7. PubMed 26744140 ↗
• Wagner M, Hectors S, Bane O, Gordic S, Kennedy P, Besa C, Schiano TD, Thung S, Fischman A, Taouli B. Noninvasive prediction of portal pressure with MR elastography and DCE-MRI of the liver and spleen: Preliminary results. J Magn Reson Imaging. 2018 Oct;48(4):1091-1103. doi: 10.1002/jmri.26026. Epub 2018 Apr 11. PubMed 29638020 ↗
• Jajamovich GH, Calcagno C, Dyvorne HA, Rusinek H, Taouli B. DCE-MRI of the liver: reconstruction of the arterial input function using a low dose pre-bolus contrast injection. PLoS One. 2014 Dec 29;9(12):e115667. doi: 10.1371/journal.pone.0115667. eCollection 2014. PubMed 25546176 ↗

Study documents

• Protocol and statistical analysis plan · Sep 16, 2016

Documents are hosted by the registry — open the source record to download them.