Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Other: Electronic Health Record Review
    Ancillary studies
  • Procedure: Liver Biopsy
    Undergo liver biopsy
    Other names:
    • Biopsy of Liver
  • Other: Medical Device Usage and Evaluation
    Undergo ultrasound with SHAPE technique
  • Drug: Perflutren Lipid Microspheres
    Given IV
    Other names:
    • Definity
  • Procedure: Ultrasound Imaging
    Undergo ultrasound
    Other names:
    • 2-Dimensional Grayscale Ultrasound Imaging
    • 2-Dimensional Ultrasound Imaging
    • 2D-US
    • Ultrasonography
    • Ultrasound
    • Ultrasound Test
    • Ultrasound, Medical
    • US

Recruiting Locations

Mayo Clinic in Arizona
Scottsdale, Arizona 85259
Contact:
Nirvi Dahiya, MD
Dahiya.Nirvi@mayo.edu

Mayo Clinic in Florida
Jacksonville, Florida 32224-9980
Contact:
Melanie Caserta, MD
caserta.melanie@mayo.edu

Mayo Clinic in Rochester
Rochester, Minnesota 55905
Contact:
Jaydev Dave, Ph.D
Dave.Jaydev@mayo.edu

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Clinical Trials Referral Office
855-776-0015
mayocliniccancerstudies@mayo.edu

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.