Ultrasound with Subharmonic Imaging and Subharmonic Aided Pressure Estimation (SHAPE) to Identify Portal Hypertension

Not Applicable

Recruiting

• Conditions: Portal Hypertension
• Interventions: Other: Electronic Health Record Review; Procedure: Liver Biopsy; Other: Medical Device Usage and Evaluation; Drug: Perflutren Lipid Microspheres; Procedure: Ultrasound Imaging

• Registration Number: NCT06797193
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-22
• Study First Posted: 2025-01-28
• Status Verified: 2025-03
• Study Start: 2025-03-13
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17
• Primary Completion: 2027-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Provide signed and dated informed consent form
• Willing to comply with all study procedures
• Adult patients (age of 18 years or older)
• If a female of child-bearing potential, must have a negative pregnancy test
• Be scheduled for HVPG measurement

Exclusion Criteria

• Patients who are unable to provide consent
• Females who are pregnant or nursing
• Patients with known or suspected hypersensitivity to perflutren lipid microsphere or its components, such as polyethylene glycol (PEG)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (Definity, SHAPE)	Electronic Health Record Review	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.
Diagnostic (Definity, SHAPE)	Liver Biopsy	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.
Diagnostic (Definity, SHAPE)	Medical Device Usage and Evaluation	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.
Diagnostic (Definity, SHAPE)	Perflutren Lipid Microspheres	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.
Diagnostic (Definity, SHAPE)	Ultrasound Imaging	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.

Primary Outcome Measures

Name	Time	Method
Clinically significant portal hypertension (PH)	Baseline (at time of ultrasound)	Will evaluate if subharmonic aided pressure estimation with Definity microbubbles identifies patients with clinically significant PH.
Diagnostic confidence	Baseline (at time of ultrasound)	Will evaluate if the addition of subharmonic imaging-based perfusion parameters increase the diagnostic confidence of detecting PH.

Trial Locations

Locations (3)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States