Using advanced ultrasound techniques to detect portal hypertension
Invoking Subharmonics and Subharmonic Aided Pressure Estimation (SHAPE) for Identifying Portal Hypertension
This study is testing a new ultrasound method to see if it can safely and accurately find portal hypertension in patients without needing invasive procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 3 sites (Scottsdale, Arizona and 2 other locations) |
| Trial ID | NCT06797193 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of ultrasound with subharmonic imaging and subharmonic aided pressure estimation (SHAPE) in identifying portal hypertension (PH). The study involves administering perflutren lipid microspheres to patients and performing ultrasound imaging alongside standard liver biopsy procedures. The goal is to determine if this noninvasive technique can accurately identify clinically significant PH, which is traditionally assessed through invasive catheterization. By improving early detection of PH, the study aims to enhance patient outcomes and monitoring.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients scheduled for hepatic venous pressure gradient measurement who can provide informed consent.
Not a fit: Patients who are pregnant, nursing, or have known hypersensitivity to the study drug will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer, noninvasive method for early detection of portal hypertension, potentially reducing complications and mortality rates.
How similar studies have performed: Other studies have explored noninvasive techniques for assessing portal hypertension, but the specific use of SHAPE with subharmonic imaging is a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Scottsdale, Arizona and 2 other locations
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Jaydev K. Dave, PhD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.