Ultrasound for Portal Hypertension

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Jaydev K. Dave, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Mayo Clinic

No Placebo Group

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

I am 18 years old or older.

Willing to comply with all study procedures

Provide signed and dated informed consent form

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)

Trial 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) (Medical Device)
• Ultrasound with Subharmonic Imaging (Ultrasound 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+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine