Recruiting

Ultrasound with SHAPE

Sponsor:

Mayo Clinic

Code:

NCT06797193

Conditions

Portal Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Electronic Health Record Review

Liver Biopsy

Medical Device Usage and Evaluation

Perflutren Lipid Microspheres

Ultrasound Imaging

Study Details

Brief 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.

Conditions

Portal Hypertension

Study ID

NCT06797193

Start date

Mar 13, 2025

Status verified date

Aug, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Diagnostic (Definity, SHAPE)

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.

Interventions

Electronic Health Record Review

Ancillary studies

Liver Biopsy

Undergo liver biopsy

Medical Device Usage and Evaluation

Undergo ultrasound with SHAPE technique

Perflutren Lipid Microspheres

Given IV

Ultrasound Imaging

Undergo ultrasound

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Bea Hartke

507-284-9653

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Nirvi Dahiya, MD

Dahiya.Nirvi@mayo.edu

Aubrey Smith

480-301-6104

Principal Investigator:

Nirvi Dahiya, MD

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Melanie Caserta, MD

caserta.melanie@mayo.edu

Robert P. Jones

904-953-1594

Principal Investigator:

Melanie P. Caserta, MD

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Principal Investigator:

Jaydev K. Dave, PhD

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-14.