Detection of Liver Fibrosis With Magnetic Resonance Imaging (MRI)

NCT01600105 | Completed Phase 4 Results FDA Drug

• 1 other identifier: GCO 09-1187
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Liver Disease

Keywords

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

Outcome Measures

Primary Outcomes (7)

• 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.

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

• 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.

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

• 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.

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

• 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

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

• 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

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

• 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

  Fasting transient elastography, average duration 10 min

• 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

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

Secondary Outcomes (9)

• Liver Upslope From DCE-MRI

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

• Liver Time to Peak (TTP) for PH

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

• LS-MRE Portal Hypertension for Sub Study III

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

• Spleen Volume

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

• Spleen Caudocranial Diameter

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

Study Arms (1)

Perfusion MRI

EXPERIMENTAL

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

Perfusion MRI DRUG

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)

Perfusion MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic liver disease (including viral hepatitis, alcoholic hepatitis, non alcoholic steatohepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, etc..)
• 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
• years of age and older
• Subject is able to give informed consent for this study and agrees to provide a blood sample

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bachir Taouli: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (4)

• 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.

  PMID: 24840288 RESULT

• 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.

  PMID: 26744140 RESULT

• 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.

  PMID: 29638020 RESULT

• 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.

  PMID: 25546176 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Hepatitis, Chronic

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hepatitis; Chronic Disease; Disease Attributes

Results Point of Contact

• Title: Dr. Bachir Taouli
• Organization: Icahn School of Medicine at Mount Sinai

bachir.taouli@mountsinai.org

212-824-8475

Study Officials

• Bachir Taouli, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: May 16, 2012
• Study Start: October 1, 2010
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: February 7, 2020
• Results First Posted: March 11, 2019

Record last verified: 2020-01

Locations

US (1)