60 Participants Needed

Ultrasound for Portal Hypertension

Recruiting at 2 trial locations
CT
BH
Overseen ByBea Hartke
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a special type of ultrasound, called Ultrasound with Subharmonic Imaging, in detecting portal hypertension (high blood pressure in the vein leading to the liver). Unlike the usual needle-based method, this ultrasound uses sound waves and a contrast agent to capture images and estimate pressure noninvasively. The goal is to detect portal hypertension early and monitor it without invasive procedures. The trial seeks adults already scheduled for a standard pressure test involving catheterization. As an unphased trial, this study offers the opportunity to contribute to innovative research that could lead to less invasive diagnostic options.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this ultrasound technique is safe for identifying portal hypertension?

Previous studies have shown that ultrasound with subharmonic imaging and the SHAPE technique is safe for patients. This method uses sound waves to create images and measure internal pressure without surgery. Unlike traditional methods that require incisions, this technique is noninvasive.

Reports suggest it is well-tolerated, with no significant side effects linked to its use. This new ultrasound technique aims to simplify checking for portal hypertension (high blood pressure in the liver's blood vessels) without the risks of invasive procedures.12345

Why are researchers excited about this trial?

Researchers are excited about using ultrasound with subharmonic imaging for portal hypertension because it offers a non-invasive way to assess liver health. Unlike traditional methods that often rely on invasive liver biopsies, this approach uses sound waves to get detailed images of the liver and its blood flow. The addition of the SHAPE technique aims to enhance these images, potentially providing more accurate diagnosis and monitoring of portal hypertension without the need for repeated invasive procedures. This could lead to earlier interventions and better management of the condition.

What evidence suggests that this ultrasound technique is effective for identifying portal hypertension?

Research has shown that the SHAPE technique, used in ultrasound imaging, can effectively estimate high blood pressure in the vein to the liver (portal hypertension) without invasive procedures. In this trial, participants will undergo ultrasound both with and without the SHAPE technique. One study found that the pressure readings from this method closely match those from traditional, more invasive tests. Additionally, SHAPE can detect both early signs and more obvious cases of portal hypertension with high accuracy, effectively identifying the condition when present. This suggests that SHAPE could reliably detect portal hypertension without invasive tests.23567

Who Is on the Research Team?

JK

Jaydev K. Dave, PhD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This trial is for individuals with liver cirrhosis or portal hypertension, who may benefit from a noninvasive method to detect high blood pressure in the vein leading to the liver. Specific eligibility criteria are not provided, but typically include adults meeting certain health standards.

Inclusion Criteria

Willing to comply with all study procedures
Provide signed and dated informed consent form
I am scheduled for a liver pressure test.
See 1 more

Exclusion Criteria

I am not pregnant or nursing.
I am unable to give consent by myself.
Patients with known or suspected hypersensitivity to perflutren lipid microsphere or its components, such as polyethylene glycol (PEG)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive Definity IV and undergo ultrasound with and without SHAPE technique as well as standard of care liver biopsy

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 minutes
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Subharmonic Aided Pressure Estimation (SHAPE)
  • Ultrasound with Subharmonic Imaging
Trial Overview The study tests an ultrasound technique called SHAPE that uses sound waves and a contrast agent to estimate blood pressure in veins without invasive procedures. It aims to identify portal hypertension early on, which could improve monitoring and treatment.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Diagnostic (Definity, SHAPE)Experimental Treatment5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/22920550/
Investigating the efficacy of subharmonic aided pressure ...Portal vein pressures estimated using subharmonic aided pressure estimation did not reveal significant differences (p > 0.05) with respect to the pressures ...
Subharmonic aided pressure estimation in portal ...Subharmonic aided pressure estimation in portal hypertension: A noninvasive ultrasound-based technique to assess portal pressure gradient.
Ultrasound With Subharmonic Imaging and ...This clinical trial tests the how well an ultrasound with subharmonic imaging and the subharmonic aided pressure estimation (SHAPE) technique ...
A comparative evaluation of two subharmonic-aided ...The objective of this work is to compare the two methods, SHAPE and fast-SHAPE, in the same patients, to explore the utility of fast-SHAPE.
Subharmonic Aided Pressure Estimation in Portal ...The results indicated that optimised subharmonic signals could discern both subclinical and clinical portal hypertension with high sensitivity and acceptable ...
Contrast-Enhanced Subharmonic Aided Pressure ...A protocol for noninvasively, estimating ambient pressures utilizing subharmonic ultrasound imaging of infused contrast microbubbles.
NCT04720456 | SHAPE of Portal Hypertension in ChildrenHence, this trial will investigate the safety and efficacy of subharmonic aided pressure estimation (SHAPE) as a noninvasive ultrasound technique for diagnosing ...
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