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

Invoking Subharmonics and Subharmonic Aided Pressure Estimation (SHAPE) for Identifying Portal Hypertension

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
• Study Contact Backup: Name: Bea Hartke; Phone Number: 507-284-9653

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic in Arizona
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Contact: Aubrey Smith; Phone Number: 480-301-6104
      • Principal Investigator: Nirvi Dahiya, MD
  • Florida
    • Jacksonville, Florida, United States, 32224-9980
      • Recruiting
      • Mayo Clinic in Florida
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Melanie P. Caserta, MD
      • Contact: Robert P. Jones; Phone Number: 904-953-1594
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Contact: Bea Hartke; Phone Number: 507-422-6527
      • Principal Investigator: Jaydev K. Dave, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Diagnostic (Definity, SHAPE); 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; Ancillary studies; Procedure: Liver Biopsy; Undergo liver biopsy; Other Names: Biopsy of Liver; Drug: Perflutren Lipid Microspheres; Given IV; Other Names: Definity; Procedure: Ultrasound Imaging; Undergo ultrasound; Other Names: Ultrasound; 2-Dimensional Grayscale Ultrasound Imaging; 2-Dimensional Ultrasound Imaging; 2D-US; Ultrasound Test; Ultrasound, Medical; US; Ultrasonography; Other: Medical Device Usage and Evaluation; Undergo ultrasound with SHAPE technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically significant portal hypertension (PH)	Will evaluate if subharmonic aided pressure estimation with Definity microbubbles identifies patients with clinically significant PH.	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.	Baseline (at time of ultrasound)

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Jaydev K. Dave, PhD, Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): January 28, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Hypertension, Portal; Physical Phenomena; Radiation; Radiation, Nonionizing; Ultrasonic Waves; Sound; High-Energy Shock Waves; perflutren
• Other Study ID Numbers: 24-008738 (Mayo Clinic Institutional Review Board); NCI-2025-00039 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No