Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06797193

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

Led by Mayo Clinic · Updated on 2025-12-23

60

Participants Needed

3

Research Sites

106 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Mayo Clinic in Arizona

Scottsdale, Arizona, United States, 85259

Actively Recruiting

2

Mayo Clinic in Florida

Jacksonville, Florida, United States, 32224-9980

Actively Recruiting

3

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

C

Clinical Trials Referral Office

CONTACT

B

Bea Hartke

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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