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Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension

This study is looking at a new way to measure portal hypertension (high blood pressure in the vein that carries blood to the liver) without invasive procedures. It uses a technique called SHAPE with two different ultrasound contrast agents, Sonazoid and Definity. Researchers want to see how consistently SHAPE measures liver pressure. They will also track if participants develop ascites (fluid buildup in the abdomen) or other serious liver problems like variceal bleeding for up to 18 months. You may be able to join if you are at least 18 years old, medically stable, and can understand and sign the consent form. The study aims to enroll 660 participants.

Study design
This is an open-label, non-randomized study involving 660 participants across three sites. Participants will be divided into four groups based on specific criteria.
What's involved
You will undergo SHAPE measurements using Sonazoid and/or Definity contrast agents, which are infused intravenously. Ultrasound imaging will be performed during these infusions, lasting approximately 6-12 minutes per infusion.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 18 months to monitor for ascites or other clinical decompensation events.

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NCT05470205

Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension; Renewal

Recruiting
PHASE3Ages 18+InterventionalDiagnostic
Thomas Jefferson University
~660 participants
Updated 2025-02-11 on ClinicalTrials.gov
What's tested:SHAPE measurement (Sonazoid ultrasoud contrast agent)SHAPE measurement (Definity ultrasoud contrast agent)

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Reproducibility of SHAPE liver pressure measurements
Measured over during procedure
+3 more outcomes measured

Conditions

Liver Diseases
Portal Hypertension

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Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Thomas Jefferson University, Dept of Radiology

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

  • University of Bern

    Bern, Switzerlandstudy coordinator listed

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Flemming Forsberg, PhD · PRINCIPAL_INVESTIGATOR · Thomas Jefferson University

Who to contact

Flemming Forsberg, PhD
[email protected]
215-955-4870
Email the study team

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Eligibility criteria

Inclusion

Be at least 18 years of age.
Be medically stable.
If a female of child-bearing potential, must have a negative pregnancy test.
Be conscious and able to comply with study procedures.
Have read and signed the IRB-approved Informed Consent form for participating in the study.

Exclusion

Females who are pregnant or nursing.
Patients with pulmonary hypertension or unstable cardiopulmonary conditions
Patients currently on chemotherapy or with other primary cancers requiring systemic or hepatic loco-regional treatment.
Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
Patients on life support or in a critical care unit.
Patients with unstable occlusive disease (e.g., crescendo angina)
Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia.
Patients with uncontrolled congestive heart failure (NYHA Class IV)
Patients with recent cerebral hemorrhage.
Patients who have undergone surgery within 24 hours prior to the study sonographic examination.
Patients with a history of anaphylactic allergy to eggs or egg products, manifested by one or more of the following symptoms: generalized urticaria, difficulty in breathing, swelling of the mouth and throat, hypotension, or shock. (Subjects with nonanaphylactic allergies to eggs or egg products may be enrolled in the study, but must be watched carefully for 1 hour following the administration of Sonazoid).
Patients with congenital heart defects.
Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli.
Patients with respiratory distress syndrome
Patients with thrombosis within the hepatic, portal, or mesenteric veins.
Patients with grade 2 and above of hepatic encephalopathy within the last 3 months

What this trial measures

  • Reproducibility of SHAPE liver pressure measurementsduring procedure

    Evaluate the use of in vivo SHAPE with 2 ultrasound contrast agents (Sonazoid and Definity) for determining the presence of portal hypertension in patients undergoing a transjugular liver biopsy using catheter based pressure measurements as the reference standard.

  • Number of subjects who develop ascites during follow-upup to 18 months

    Determine if SHAPE estimates of portal vein pressures in patients with compensated cirrhosis can predict the development of ascites (i.e., the progression into decompensated cirrhosis or HVPG \> 16 mmHg).

  • Number of subjects who experience clinical decompensation events (including the development of variceal bleeding) during follow-upup to 18 months

    Determine if SHAPE measurements can monitor treatment response (i.e., the ability to accurately assess the response to non-selective beta blockers) in patients newly diagnosed with portal hypertension better than elastography.

  • Number of subjects who present with esophageal or gastric varices on endoscopybaseline

    In subjects allocated to endoscopic screening for varices based on their clinical risk assessment the outcome of the endoscopic procedure will be compared to their SHAPE values