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

Mayo Clinic · NCT06797193

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
60
US sites recruiting
3
Study start
March 13, 2025
Record last updated
August 14, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Electronic Health Record Review; Liver Biopsy; Medical Device Usage and Evaluation; Perflutren Lipid Microspheres; Ultrasound Imaging

Conditions: Portal Hypertension

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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)

Recruiting US locations

  • Mayo Clinic in Arizona

    Scottsdale, AZ 85259

    Site contact: Nirvi Dahiya, MD · Dahiya.Nirvi@mayo.edu

  • Mayo Clinic in Florida

    Jacksonville, FL 32224-9980

    Site contact: Melanie Caserta, MD · caserta.melanie@mayo.edu

  • Mayo Clinic in Rochester

    Rochester, MN 55905

    Site contact: Jaydev Dave, Ph.D · Dave.Jaydev@mayo.edu

Study contacts (from the official record)

  • Clinical Trials Referral Office · 855-776-0015 · mayocliniccancerstudies@mayo.edu
  • Bea Hartke · 507-284-9653
Ultrasound With Subharmonic Imaging and Subharmonic Aided Pressure… (NCT06797193) | Bored Studies