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Ultrasound With Subharmonic Imaging and Subharmonic Aided Pressure Estimation (SHAPE) to Identify Portal Hypertension

NCT ID: NCT06797193

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-13

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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PRIMARY OBJECTIVES:

I. 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

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Portal Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Liver Biopsy

Intervention Type PROCEDURE

Undergo liver biopsy

Medical Device Usage and Evaluation

Intervention Type OTHER

Undergo ultrasound with SHAPE technique

Perflutren Lipid Microspheres

Intervention Type DRUG

Given IV

Ultrasound Imaging

Intervention Type PROCEDURE

Undergo ultrasound

Interventions

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Electronic Health Record Review

Ancillary studies

Intervention Type OTHER

Liver Biopsy

Undergo liver biopsy

Intervention Type PROCEDURE

Medical Device Usage and Evaluation

Undergo ultrasound with SHAPE technique

Intervention Type OTHER

Perflutren Lipid Microspheres

Given IV

Intervention Type DRUG

Ultrasound Imaging

Undergo ultrasound

Intervention Type PROCEDURE

Other Intervention Names

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Biopsy of Liver Definity 2-Dimensional Grayscale Ultrasound Imaging 2-Dimensional Ultrasound Imaging 2D-US Ultrasonography Ultrasound Ultrasound Test Ultrasound, Medical US

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Jaydev K. Dave, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaydev K. Dave, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

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Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Clinical Trials Referral Office

Role: CONTACT

Phone: 855-776-0015

Email: [email protected]

Bea Hartke

Role: CONTACT

Phone: 507-284-9653

Facility Contacts

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Clinical Trials Referral Office

Role: primary

Aubrey Smith

Role: backup

Clinical Trials Referral Office

Role: primary

Robert P. Jones

Role: backup

Clinical Trials Referral Office

Role: primary

Bea Hartke

Role: backup

Related Links

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https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

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24-008738

Identifier Type: -

Identifier Source: org_study_id