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

Official title

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

Overview

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.

Interventions

• Other Electronic Health Record Review
  Ancillary studies
• Procedure Liver Biopsy
  Undergo liver biopsy
• Other Medical Device Usage and Evaluation
  Undergo ultrasound with SHAPE technique
• Drug Perflutren Lipid Microspheres
  Given IV
• Procedure Ultrasound Imaging
  Undergo ultrasound

Primary outcome measures

• Clinically significant portal hypertension (PH) [Time frame: Baseline (at time of ultrasound)]
• Diagnostic confidence [Time frame: Baseline (at time of ultrasound)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 3 centers

• Mayo Clinic in Arizona — Scottsdale
• Mayo Clinic in Florida — Jacksonville
• Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT06797193 · 24-008738

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗