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

NCT06797193 | Recruiting

• 1 other identifier: 24-008738
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Portal Hypertension

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

Diagnostic (Definity, SHAPE)

EXPERIMENTAL

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

Interventions

Electronic Health Record Review OTHER

Ancillary studies

Diagnostic (Definity, SHAPE)

Liver Biopsy PROCEDURE

Undergo liver biopsy

Also known as: Biopsy of Liver

Diagnostic (Definity, SHAPE)

Medical Device Usage and Evaluation OTHER

Undergo ultrasound with SHAPE technique

Diagnostic (Definity, SHAPE)

Perflutren Lipid Microspheres DRUG

Given IV

Also known as: Definity

Diagnostic (Definity, SHAPE)

Ultrasound Imaging PROCEDURE

Undergo ultrasound

Also known as: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography, Ultrasound, Ultrasound Test, Ultrasound, Medical, US

Diagnostic (Definity, SHAPE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Hypertension, Portal

Interventions

perflutren; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Jaydev K. Dave, PhD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Bea Hartke

CONTACT

507-284-9653

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: March 13, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)