Ultrasound With Subharmonic Imaging and Subharmonic Aided Pressure Estimation (SHAPE) to Identify Portal Hypertension
Mayo Clinic · NCT06797193
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
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