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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • Electronic Health Record Review

    Other intervention

    Ancillary studies

  • Liver Biopsy

    Procedure/Surgery

    Undergo liver biopsy

  • Medical Device Usage and Evaluation

    Other intervention

    Undergo ultrasound with SHAPE technique

  • Perflutren Lipid Microspheres

    Drug

    Given IV

  • Ultrasound Imaging

    Procedure/Surgery

    Undergo ultrasound

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Diagnostic (Definity, SHAPE)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Clinically significant portal hypertension (PH)

Will evaluate if subharmonic aided pressure estimation with Definity microbubbles identifies patients with clinically significant PH.

Time frame
Baseline (at time of ultrasound)
2

Diagnostic confidence

Will evaluate if the addition of subharmonic imaging-based perfusion parameters increase the diagnostic confidence of detecting PH.

Time frame
Baseline (at time of ultrasound)

Secondary outcomes

Other outcomes

Sponsors and contacts

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