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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03652636
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : February 11, 2020
Information provided by (Responsible Party):
Jordan K. Swensson, Indiana University

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

Condition or disease Intervention/treatment Phase
Hepatic Disease Other: Ultrasound of liver Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Contrast Enhanced Ultrasound Compared to MRI for Differentiation of Hepatic Lesions
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Patient scheduled to get MRI will also be asked to receive an ultrasound of the liver
Other: Ultrasound of liver
From the MRI schedule at the performance site, a radiology investigator will prospectively identify patients who are to undergo abdominal MRI with hepatobiliary contrast and who otherwise meet entry criteria. Exclusion criteria will be evaluated by consulting the medical record. At the time of MRI scanning, an investigator will meet with the potential subject, confirm that exclusion criteria are not met, explain the study, answer any questions, and seek written informed consent. If consent is granted, CEUS of the liver will be scheduled on the same day or near the same day.

Primary Outcome Measures :
  1. new method diagnosing hepatic lesions [ Time Frame: Two years ]
    To compare the ability of contrast enhanced ultrasound to differentiate between hepatic adenoma and FNH compared with the current standard of contrast enhnaced MRI.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03652636

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Contact: Jordan Swensson, MD 3179630305
Contact: Sarah Munson, RN 3179630305

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United States, Indiana
IU University Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jordan Swensson, MD    317-963-0305   
Sponsors and Collaborators
Indiana University

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Responsible Party: Jordan K. Swensson, Assistant Professor of Clinical Radiology and Imaging Sciences, Indiana University Identifier: NCT03652636    
Other Study ID Numbers: RADY-SWENSSON
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases