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.
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Ultrasound With Subharmonic Imaging and Subharmonic Aided Pressure Estimation (SHAPE) to Identify Portal Hypertension
At a glance
Conditions
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.
Study leadership
- Jaydev K. Dave, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester
Who to contact
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Inclusion
Exclusion
What this trial measures
- 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.