Trial Outcomes & Findings for Evaluation of the Efficacy of Contrast Enhanced Ultrasound Compared to MRI for Differentiation of Hepatic Lesions (NCT NCT03652636)

Results Overview

To compare the ability of contrast enhanced ultrasound to differentiate between hepatic adenoma and FNH compared with the current standard of contrast enhanced MRI.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

47 participants

Primary outcome timeframe

One day

Results posted on

2024-10-02

Participant Flow

Participant milestones

Participant milestones
Measure	=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.
Overall Study STARTED	47
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	=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.
Overall Study Withdrawal by Subject	7

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	=Patient Population With Liver Lesion(s) n=40 Participants 40 patients with liver lesion(s) identified in MRI
Age, Continuous	36.7 years STANDARD_DEVIATION 9.9 • n=40 Participants
Sex: Female, Male Female	38 Participants n=40 Participants
Sex: Female, Male Male	2 Participants n=40 Participants
Region of Enrollment United States	40 participants n=40 Participants

PRIMARY outcome

Timeframe: 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

To compare the ability of contrast enhanced ultrasound to differentiate between hepatic adenoma and FNH compared with the current standard of contrast enhanced MRI.

Outcome measures

Outcome measures
Measure	Reader 1 - CEUS Sensitivity / Specificity Differentiating FNH & HCA n=59 Liver lesions 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	Reader 2 - CEUS Sensitivity / Specificity Differentiating FNH & HCA n=59 Liver lesions 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
Accuracy of CEUS at Differentiating Focal Nodular Hyperplasia (FNH) From Hepatocellular Adenoma (HCA) Sensitivity (true positive rate)	66.7 percentage of lesions	64.0 percentage of lesions
Accuracy of CEUS at Differentiating Focal Nodular Hyperplasia (FNH) From Hepatocellular Adenoma (HCA) Specificity (true negative rate)	71.9 percentage of lesions	90.6 percentage of lesions
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	78.0 percentage of lesions

SECONDARY outcome

Timeframe: 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

To compare the ability of contrast enhanced ultrasound to differentiate FNH from HCA

Outcome measures

Outcome measures
Measure	Reader 1 - CEUS Sensitivity / Specificity Differentiating FNH & HCA n=59 liver lesions 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	Reader 2 - CEUS Sensitivity / Specificity Differentiating FNH & HCA n=59 liver lesions 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
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	0.768 Probability of correct evaluation

Adverse Events

=Patient Population With Liver Lesion(s)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jordan Swensson, MD

Indiana University

Phone: 317-944-1837

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place