Invoking Subharmonics and Subharmonic Aided Pressure Estimation (SHAPE) for Identifying Portal Hypertension

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other, Drug, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
United States
Arizona
Mayo Clinic in Arizona
NOT_YET_RECRUITING
Scottsdale
Florida
Mayo Clinic in Florida
NOT_YET_RECRUITING
Jacksonville
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
Contact Information
Primary
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Backup
Bea Hartke
507-284-9653
Time Frame
Start Date: 2025-03-13
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 60
Treatments
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.
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov

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