Ultrasound with SHAPE for Portal Hypertension

This study is testing a new way to identify portal hypertension (PH), which is high blood pressure in the vein that carries blood to your liver. This condition can lead to serious liver problems. Researchers are using a special ultrasound technique called subharmonic imaging with Subharmonic Aided Pressure Estimation (SHAPE), along with an IV medication called Perflutren Lipid Microspheres (Definity). The goal is to see how well this method can detect PH early. You may be able to join if you are an adult (18 or older), are scheduled for a special measurement called HVPG, and meet other health criteria. The study will look at how accurately this ultrasound method can diagnose PH and how confident doctors are in the diagnosis. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 60 participants. It will evaluate the effectiveness of ultrasound with SHAPE in identifying portal hypertension.
What's involved
You would receive Definity intravenously once, undergo ultrasound with and without the SHAPE technique, and have a standard liver biopsy.
Compensation
Not stated in the trial record.
Follow-up
After the study intervention, participants will be followed for 30 minutes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06797193

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

Recruiting
NAAges 18+InterventionalDiagnostic
Mayo Clinic
~60 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Electronic Health Record ReviewLiver BiopsyMedical Device Usage and EvaluationPerflutren Lipid MicrospheresUltrasound Imaging

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinically significant portal hypertension (PH)
Measured over Baseline (at time of ultrasound)
+1 more outcome measured
Portal Hypertension

NCT06797193

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic in Arizona

    Scottsdale, Arizonastudy coordinator listed

    Recruiting

  • Mayo Clinic in Florida

    Jacksonville, Floridastudy coordinator listed

    Recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesotastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Jaydev K. Dave, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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)
  • Clinically significant portal hypertension (PH)Baseline (at time of ultrasound)

    Will evaluate if subharmonic aided pressure estimation with Definity microbubbles identifies patients with clinically significant PH.

  • Diagnostic confidenceBaseline (at time of ultrasound)

    Will evaluate if the addition of subharmonic imaging-based perfusion parameters increase the diagnostic confidence of detecting PH.