An interventional study of Electronic Health Record Review and Liver Biopsy in Portal Hypertension, sponsored by Mayo Clinic. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Diagnostic
This clinical trial tests the how well an ultrasound with subharmonic imaging and the subharmonic aided pressure estimation (SHAPE) technique works in identifying portal hypertension (PH). An ultrasound takes pictures of the inside of the body by bouncing sound waves off organs. PH is high blood pressure in the vein that carries blood to the liver from the stomach, small and large intestines, spleen, pancreas, and gallbladder. The complications associated with PH are clear only after severe liver dysfunction or liver cirrhosis develops and are accompanied by relatively high mortality rates (20-70% mortality within 2 years). Thus, identifying PH earlier is beneficial. The hepatic venous pressure gradient (HVPG) obtained using an invasive catheterization procedure remains the standard for assessing PH. However, using this invasive procedure to assess PH prevents frequent pressure monitoring. Thus, a noninvasive technique to estimate PH is beneficial not only for diagnosis but also for monitoring treatment and disease progression. The SHAPE technique is a noninvasive ultrasound-based imaging technique that can estimate pressure with an ultrasound contrast agent. A noninvasive technique using an ultrasound with subharmonic imaging and the SHAPE technique may work in identifying PH.
PRIMARY OBJECTIVES:
I. To evaluate if SHAPE with perflutren lipid microspheres (Definity) microbubbles identifies patients with clinically significant PH.
II. To evaluate if addition of subharmonic imaging-based perfusion parameters derived from time intensity curves and shear wave elastography (SWE) measurements increase the diagnostic confidence of detecting PH.
OUTLINE:
Patients receive Definity intravenously (IV) once on study. Additionally, patients undergo ultrasound with and without SHAPE technique as well as standard of care liver biopsy on study.
After completion of study intervention, patients are followed up for 30 minutes.
332 studies on the registry are indexed under Hypertension, Portal; 106 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 206 interventional studies indexed under Hypertension, Portal.
Browse Hypertension, Portal studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive Definity IV once on study. Additionally, patients undergo ultrasound with and without SHAPE technique as well as standard of care liver biopsy on study.
Other: Electronic Health Record Review · Procedure: Liver Biopsy · Other: Medical Device Usage and Evaluation · Drug: Perflutren Lipid Microspheres · Procedure: Ultrasound Imaging
Ancillary studies
Undergo liver biopsy
Also known as: Biopsy of Liver
Undergo ultrasound with SHAPE technique
Given IV
Also known as: Definity
Undergo ultrasound
Also known as: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography, Ultrasound, Ultrasound Test, Ultrasound, Medical, US
Clinically significant portal hypertension (PH)
Will evaluate if subharmonic aided pressure estimation with Definity microbubbles identifies patients with clinically significant PH.
Time frame: Baseline (at time of ultrasound)
Diagnostic confidence
Will evaluate if the addition of subharmonic imaging-based perfusion parameters increase the diagnostic confidence of detecting PH.
Time frame: Baseline (at time of ultrasound)
Plan to share: No
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