Phase 4
Completed N=47
Evaluation of the Efficacy of Contrast Enhanced Ultrasound Compared to MRI for Differentiation of Hepatic Lesions
Hepatic Disease
Source: ClinicalTrials.gov NCT03652636 ↗
Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Accuracy of CEUS at Differentiating Focal Nodular Hyperplasia (FNH) From Hepatocellular Adenoma (HCA) — 66.7; 64.0; 71.9; 90.6 percentage of lesions
◆ Published Evidence
Emerging
3citations · ~2 / year
Contrast-Enhanced Ultrasound Compared With Hepatobiliary Agent MRI for Differentiation of Focal Nodular Hyperplasia and Hepatic Adenoma: A Prospective Trial.
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.
Linked Publications
-
Contrast-Enhanced Ultrasound Compared With Hepatobiliary Agent MRI for Differentiation of Focal Nodular Hyperplasia and Hepatic Adenoma: A Prospective Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of CEUS at Differentiating Focal Nodular Hyperplasia (FNH) From Hepatocellular Adenoma (HCA) |
66.7; 64.0; 71.9; 90.6; 69.5; 78.0 | — |
| 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) |
0.693; 0.768 | — |
Eligibility Criteria
Inclusion Criteria
- Males and females
- Age 18 years or greater
- Scheduled to undergo abdominal MRI with contrast at a performance site for evaluation of a hepatic lesion(s).
Exclusion criteria
- History of cardiac shunting
- History of acute cardiac ischemia
- History of hypersensitivity reaction to Lumason
Data sourced from ClinicalTrials.gov (NCT03652636) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.