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In patients with hepatic lesions, to evaluate the efficacy of contrast enhanced ultrasound compared to MRI in differentiating focal nodular hyperplasia and hepatic adenoma.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One: Patient population with hepatic lesion(s) | Other | Patient scheduled to get MRI will also be asked to receive an ultrasound of the liver |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulfur Hexafluoride Microspheres | Drug | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jordan K Swennson, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU University Hospital | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39589314 | Derived | Swensson J, McCrate M, Halappa VG, Stethen T, Akisik F. Contrast-Enhanced Ultrasound Compared With Hepatobiliary Agent MRI for Differentiation of Focal Nodular Hyperplasia and Hepatic Adenoma: A Prospective Trial. Ultrasound Q. 2024 Nov 22;40(4):e00696. doi: 10.1097/RUQ.0000000000000696. eCollection 2024 Dec 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | =Patient Population With Liver Lesion(s) | Patients with hepatic lesion(s) scheduled to get MRI will also be asked to receive an ultrasound of the liver. Sulfur Hexafluoride Microspheres (2.5 mL) intravenous injection will be given at the time of ultrasound, with second 2.5 mL intravenous injection given during ultrasound as needed to improve visualization. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | =Patient Population With Liver Lesion(s) | 40 patients with liver lesion(s) identified in MRI |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 59 liver lesions were evaluated with a one time contrast enhanced ultrasound. Two blinded radiologists then evaluated the CEUS images and gave a diagnosis of FNH or HCA | Posted | Number | percentage of lesions | One day | Liver lesions | Liver lesions |
|
One day
Reporting uses standard definitions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | =Patient Population With Liver Lesion(s) | 40 patients with liver lesion(s) identified in MRI |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jordan Swensson, MD | Indiana University | 317-944-1837 | jswensso@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 20, 2019 | Aug 1, 2024 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 20, 2019 | Aug 2, 2024 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 20, 2019 | Aug 27, 2024 | ICF_004.pdf |
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| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Reader 2 - CEUS Sensitivity / Specificity Differentiating FNH & HCA | Patients with hepatic lesion(s) scheduled to get MRI will also be asked to receive an ultrasound of the liver. Sulfur Hexafluoride Microspheres (2.5 mL) intravenous injection will be given at the time of ultrasound, with second 2.5 mL intravenous injection given during ultrasound as needed to improve visualization |
|
|
| Secondary | 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 | 59 liver lesions were evaluated with a one time contrast enhanced ultrasound. Two blinded radiologists then evaluated the CEUS images and gave a diagnosis of FNH or HCA | Posted | Number | Probability of correct evaluation | One day | liver lesions | liver lesions |
|
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| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
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