Hepatic Disease
Conditions
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.
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.
Interventions
DRUGSulfur 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
Sponsors
Indiana University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of CEUS at Differentiating Focal Nodular Hyperplasia (FNH) From Hepatocellular Adenoma (HCA) | One day | To compare the ability of contrast enhanced ultrasound to differentiate between hepatic adenoma and FNH compared with the current standard of contrast enhanced MRI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | One day | To compare the ability of contrast enhanced ultrasound to differentiate FNH from HCA |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| =Patient Population With Liver Lesion(s) 40 patients with liver lesion(s) identified in MRI | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | =Patient Population With Liver Lesion(s) | — |
|---|---|---|
| Age, Continuous | 36.7 years STANDARD_DEVIATION 9.9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 40 participants | — |
| Sex: Female, Male Female | 38 Participants | — |
| Sex: Female, Male Male | 2 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
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.
Time frame: One day
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Reader 1 - CEUS Sensitivity / Specificity Differentiating FNH & HCA | Accuracy of CEUS at Differentiating Focal Nodular Hyperplasia (FNH) From Hepatocellular Adenoma (HCA) | Sensitivity (true positive rate) | 66.7 percentage of lesions |
| Reader 1 - CEUS Sensitivity / Specificity Differentiating FNH & HCA | Accuracy of CEUS at Differentiating Focal Nodular Hyperplasia (FNH) From Hepatocellular Adenoma (HCA) | Specificity (true negative rate) | 71.9 percentage of lesions |
| Reader 1 - CEUS Sensitivity / Specificity Differentiating FNH & HCA | Accuracy of CEUS at Differentiating Focal Nodular Hyperplasia (FNH) From Hepatocellular Adenoma (HCA) | Accuracy (is the ultrasound assessment of the lesion correct) | 69.5 percentage of lesions |
| Reader 2 - CEUS Sensitivity / Specificity Differentiating FNH & HCA | Accuracy of CEUS at Differentiating Focal Nodular Hyperplasia (FNH) From Hepatocellular Adenoma (HCA) | Sensitivity (true positive rate) | 64.0 percentage of lesions |
| Reader 2 - CEUS Sensitivity / Specificity Differentiating FNH & HCA | Accuracy of CEUS at Differentiating Focal Nodular Hyperplasia (FNH) From Hepatocellular Adenoma (HCA) | Specificity (true negative rate) | 90.6 percentage of lesions |
| Reader 2 - CEUS Sensitivity / Specificity Differentiating FNH & HCA | Accuracy of CEUS at Differentiating Focal Nodular Hyperplasia (FNH) From Hepatocellular Adenoma (HCA) | Accuracy (is the ultrasound assessment of the lesion correct) | 78.0 percentage of lesions |
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
Time frame: One day
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reader 1 - CEUS Sensitivity / Specificity Differentiating FNH & HCA | 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) | 0.693 Probability of correct evaluation |
| Reader 2 - CEUS Sensitivity / Specificity Differentiating FNH & HCA | 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) | 0.768 Probability of correct evaluation |