RecruitingNot ApplicableNCT06797193

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


Sponsor

Mayo Clinic

Enrollment

60 participants

Start Date

Mar 13, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses a specialized ultrasound technique (subharmonic imaging with a contrast agent called microbubbles) to measure blood pressure inside the liver's portal vein — without needing an invasive catheter procedure. High portal vein pressure (portal hypertension) is a serious complication of liver disease, and this study aims to validate a safer way to measure it. **You may be eligible if...** - You are 18 or older - You are scheduled to have an invasive liver pressure measurement procedure (HVPG measurement) as part of your care - You are a woman of childbearing potential with a negative pregnancy test **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have a known allergy to the ultrasound contrast agent (perflutren lipid microsphere or its components, including polyethylene glycol/PEG) - You are unable to give consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERElectronic Health Record Review

Ancillary studies

PROCEDURELiver Biopsy

Undergo liver biopsy

OTHERMedical Device Usage and Evaluation

Undergo ultrasound with SHAPE technique

DRUGPerflutren Lipid Microspheres

Given IV

PROCEDUREUltrasound Imaging

Undergo ultrasound


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

View Full Details on ClinicalTrials.gov

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NCT06797193


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