Portal HypertensionNCT06797193
Ultrasound With Subharmonic Imaging and Subharmonic Aided Pressure Estimation (SHAPE) to Identify Portal Hypertension
A study testing Electronic Health Record Review, Liver Biopsy and Medical Device Usage and Evaluation in people with Portal Hypertension, run by Mayo Clinic at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Portal Hypertension
- What is being tested?
- Electronic Health Record Review, Liver Biopsy and Medical Device Usage and Evaluation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Mar 2025to 31 Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Bea Hartke contact
United States3 sites, 3 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Melanie Caserta, MD, caserta.melanie@mayo.edu
Robert P. Jones, 904-953-1594
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Jaydev Dave, Ph.D, Dave.Jaydev@mayo.edu
Bea Hartke, 507-422-6527, hartke.bea@mayo.edu
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Nirvi Dahiya, MD, Dahiya.Nirvi@mayo.edu
Aubrey Smith, 480-301-6104
About this study
Official title: Invoking Subharmonics and Subharmonic Aided Pressure Estimation (SHAPE) for Identifying Portal Hypertension
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate if SHAPE with perflutren lipid microspheres (Definity) microbubbles identifies patients with clinically significant PH.
II. To evaluate if addition of subharmonic imaging-based perfusion parameters derived from time intensity curves and shear wave elastography (SWE) measurements increase the diagnostic confidence of detecting PH.
OUTLINE:
Patients receive Definity intravenously (IV) once on study. Additionally, patients undergo ultrasound with and without SHAPE technique as well as standard of care liver biopsy on study.
After completion of study intervention, patients are followed up for 30 minutes.
- Conditions
- Portal Hypertension
- Being tested
- Electronic Health Record Review, Liver Biopsy, Medical Device Usage and Evaluation, Perflutren Lipid Microspheres, Ultrasound Imaging
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record ReviewOther
Ancillary studies
Liver BiopsyProcedure or surgery
Also called Biopsy of Liver
Undergo liver biopsy
Medical Device Usage and EvaluationOther
Undergo ultrasound with SHAPE technique
Perflutren Lipid MicrospheresDrug
Also called Definity
Given IV
Ultrasound ImagingProcedure or surgery
Also called 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography
Undergo ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (Definity, SHAPE) | Experimental | 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. Receives: Other: Electronic Health Record Review; Procedure: Liver Biopsy; Other: Medical Device Usage and Evaluation; Drug: Perflutren Lipid Microspheres; Procedure: Ultrasound Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically significant portal hypertension (PH)
Will evaluate if subharmonic aided pressure estimation with Definity microbubbles identifies patients with clinically significant PH.
Measured: Baseline (at time of ultrasound)
Diagnostic confidence
Will evaluate if the addition of subharmonic imaging-based perfusion parameters increase the diagnostic confidence of detecting PH.
Measured: Baseline (at time of ultrasound)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start13 Mar 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaydev K. Dave, PhD, Mayo Clinic
- Investigators
- Jaydev K. Dave, PhD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797193
- Sponsor's protocol ID
- 24-008738
- Status last verified
- Aug 2026
- First submitted
- 22 Jan 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No