Evaluation of the Efficacy of Contrast Enhanced Ultrasound Compared to MRI for Differentiation of Hepatic Lesions

In patients with hepatic lesions, to evaluate the efficacy of contrast enhanced ultrasound compared to MRI in differentiating focal nodular hyperplasia and hepatic adenoma.

Study Overview

• Status: Completed
• Conditions: Hepatic Disease
• Intervention / Treatment: Drug: Sulfur Hexafluoride Microspheres

Detailed Description

Hepatic imaging plays an important role in identifying and differentiating both benign and malignant neoplasms of the liver. One of the clinical and radiologic dilemmas facing hepatic medicine is the accurate differentiation of focal nodular hyperplasia (FNH) and hepatic adenoma (HA). This is a question of some import, as there are significant prognosis and treatment differences between these entities, as well as overlap in the patient populations in whom they occur.

FNH is the second most common benign neoplasm of the liver, with a strong female predilection. These lesions are usually asymptomatic and incidentally discovered, and carry only a small risk of complication such as bleeding. There is no malignant potential. Hepatic adenomas (HAs) are more rare benign neoplasms that also have a female predilection. However, these lesions are more likely to be symptomatic, and carry a higher bleeding risk especially as they grow over 4 cm. In addition, they harbor a small risk of malignant transformation to hepatocellular carcinoma (HCC). Of note, patients may present with both types of lesion concurrently.

Currently, MRI with hepatobiliary contrast agents is the standard for differentiation of these lesions. These agents (such as gadoxetate disodium, or Eovist) are actively transported into hepatocytes, which are present in FNH and only in very rare cases with HA. Previous research (such as from Grazioli et al.) has shown that hepatobiliary agents can differentiate these lesions with excellent accuracy. However, there is still overlap between these lesions on imaging, and for certain patients MRI may be difficult or impossible.

FDA approval of contrast enhanced ultrasound (CEUS) agents in 2016 has opened a new avenue for abdominal imaging. CEUS utilizes gas containing lipid microbubbles to provide pure intravascular contrast, allowing for evaluation of vascular and solid organ perfusion. It has an excellent safety profile and is not excreted by the kidneys, allowing for use in patients with acute and chronic renal disease. It has been used for some time outside of the US for liver lesion evaluation, and the enhancement patterns of both FNH and HA have been described in the literature by Kim et al. as having different appearances. CEUS can be especially useful for focal liver lesion imaging for patients who cannot or will not undergo MRI, and it has the advantages of flexibility, increased temporal resolution, and decreased cost. This study aims to compare the utility of CEUS for differentiating FNH and HA with the current standard of hepatobiliary contrast MRI.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • IU University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Males and females
2. Age 18 years or greater
3. Scheduled to undergo abdominal MRI with contrast at a performance site for evaluation of a hepatic lesion(s).

Exclusion criteria:

1. History of cardiac shunting
2. History of acute cardiac ischemia
3. History of hypersensitivity reaction to Lumason

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: One: Patient population with hepatic lesion(s); Patient scheduled to get MRI will also be asked to receive an ultrasound of the liver	Drug: Sulfur Hexafluoride Microspheres; 2.5 mL intravenous injection given at the time of ultrasound, with second 2.5 mL intravenous injection given during ultrasound as needed to improve visualization; Other Names: Lumason

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of CEUS at Differentiating Focal Nodular Hyperplasia (FNH) From Hepatocellular Adenoma (HCA)	To compare the ability of contrast enhanced ultrasound to differentiate between hepatic adenoma and FNH compared with the current standard of contrast enhanced MRI.	One day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC of Differentiating FNH From HCA (AUC Represents the Probability That the Model, if Given a Randomly Chosen Correct and Incorrect CEUS Diagnosis of a Lesion, Will Rank the Correct Higher Than the Incorrect)	To compare the ability of contrast enhanced ultrasound to differentiate FNH from HCA	One day

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Jordan K Swennson, MD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2019
• Primary Completion (Actual): July 21, 2023
• Study Completion (Actual): July 21, 2023

Study Registration Dates

• First Submitted: August 27, 2018
• First Submitted That Met QC Criteria: August 28, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: RADY-SWENSSON

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No