Ultrasound for Portal Hypertension

Recruiting at 2 trial locations

Overseen By Bea Hartke

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Nursing, Hypersensitivity to PEG, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jaydev K. Dave, PhD

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

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.

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

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)

Treatment Details

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.

Participant Groups

Group I: Diagnostic (Definity, SHAPE) Experimental Treatment 5 Interventions

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+