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SHAPE of Portal Hypertension in Children

This study is looking for children aged 6 to 21 with chronic liver disease, with or without portal hypertension (high blood pressure in the liver's blood vessels). The goal is to find a better way to diagnose and monitor portal hypertension, which can lead to serious complications like bleeding. Researchers are comparing two ultrasound contrast agents, Sonazoid and Lumason, to see how safe they are and how well they help identify portal hypertension. The study aims to see if these agents can accurately tell the difference between children with and without portal hypertension. The current status of the study is unclear.

Study design
This is an interventional study planning to enroll 120 participants. It compares two different ultrasound contrast agents.
What's involved
You would receive an ultrasound contrast agent through an IV line, followed by ultrasound imaging and data collection. This process is measured at 2 hours.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes at 2 hours after the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04720456

SHAPE of Portal Hypertension in Children

Recruiting
PHASE2Ages 6–21InterventionalDiagnostic
Thomas Jefferson University
~120 participants
Updated 2025-02-11 on ClinicalTrials.gov
What's tested:SHAPE measurement using the ultrasound contrast agent Sonazoid (perfluorobutane microbubbles)SHAPE measurement using the ultrasound contrast agent Lumason (sulfur hexafluoride lipid-type A microspheres)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The rate (%) of adverse events that occur with Sonazoid compared to the current rate of adverse events that have been reported in the Lumason package insert for pediatric use (0.001%)
Measured over 2 hours
+1 more outcome measured

Conditions

Hypertension, Portal

Explore related trials

Chronic Liver DiseasePortal Hypertension

NCT04720456

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • The Children's Hospital of Philadelphia

    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
  • Sudha A Anupindi, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia

Who to contact

Morgan L Gabbert, MA
[email protected]
267-426-0820
Email the study team

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Eligibility criteria

Inclusion

Patients with a diagnosis of chronic liver disease without portal hypertension.
Patients with a diagnosis of chronic liver disease with portal hypertension.

Exclusion

Subjects who are pregnant.
Patients with known or suspected hypersensitivity to egg phosphatidyl serine or with a history of anaphylactic allergy to eggs or egg products.
Subjects with allergy to egg products or other components of the ultrasound contrast agents will be excluded.
History of allergic reaction to Lumason®, sulfur hexafluoride, sulfur hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), palmitic acid)
History of allergic reaction to Sonazoid
Patients with biliary atresia with asplenia or polysplenia.
Patients with prior liver transplant.
Patients with cystic fibrosis.
Patients with chronic lung disease.
Patients with portal vein thrombosis, cavernous transformation of the portal vein or absent portal vein.
Adults not competent/impaired.
Patients with significant heart disease or severe congenital heart disease

What this trial measures

  • The rate (%) of adverse events that occur with Sonazoid compared to the current rate of adverse events that have been reported in the Lumason package insert for pediatric use (0.001%)2 hours
  • Calibrated subharmonic microbubble signals (in dB) between the portal and hepatic veins will differentiate between the portal hypertension and non-portal hypertension groups with an accuracy of 94%2 hours