Evaluation of the Efficacy of Contrast Enhanced Ultrasound Compared to MRI for Differentiation of Hepatic Lesions
1 other identifier
interventional
47
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2019
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2018
CompletedFirst Posted
Study publicly available on registry
August 29, 2018
CompletedStudy Start
First participant enrolled
August 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2023
CompletedResults Posted
Study results publicly available
September 19, 2024
CompletedOctober 2, 2024
September 1, 2024
4 years
August 27, 2018
June 15, 2024
September 17, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
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
Study Arms (1)
One: Patient population with hepatic lesion(s)
OTHERPatient scheduled to get MRI will also be asked to receive an ultrasound of the liver
Interventions
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
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- History of cardiac shunting
- History of acute cardiac ischemia
- History of hypersensitivity reaction to Lumason
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IU University Hospital
Indianapolis, Indiana, 46202, United States
Related Publications (1)
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.
PMID: 39589314DERIVED
MeSH Terms
Conditions
Results Point of Contact
- Title
- Jordan Swensson, MD
- Organization
- Indiana University
Study Officials
- PRINCIPAL INVESTIGATOR
Jordan K Swennson, MD
Indiana University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Clinical Radiology and Imaging Sciences
Study Record Dates
First Submitted
August 27, 2018
First Posted
August 29, 2018
Study Start
August 5, 2019
Primary Completion
July 21, 2023
Study Completion
July 21, 2023
Last Updated
October 2, 2024
Results First Posted
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share