Phase 4 N=47 Diagnostic

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

Hepatic Disease

Bottom Line

View on ClinicalTrials.gov: NCT03652636 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2024

Primary outcome: Primary: Accuracy of CEUS at Differentiating Focal Nodular Hyperplasia (FNH) From Hepatocellular Adenoma (HCA) — 66.7; 64.0; 71.9; 90.6 percentage of lesions

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Sulfur Hexafluoride Microspheres (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Indiana University
Primary completion: Jul 2023

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	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03652636). 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.