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SHAPE of Portal Hypertension in Children
Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension in Children
Who can join
Ages 6 to 21 · All sexes
Full eligibility criteria
Inclusion Criteria: * Patients with a diagnosis of chronic liver disease without portal hypertension. * Patients with a diagnosis of chronic liver disease with portal hypertension. Exclusion Criteria: * 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
About the study
Early diagnosis of portal hypertension is difficult as symptoms rarely manifest until the later stages of liver disease. Both cirrhotic and non-cirrhotic portal hypertension can result in life-threatening complications, the most frequent of which is bleeding from esophageal varices. In children, variceal bleeds are associated with mortality rates of 1-3 %, while life-threatening complications have been reported in up to 20 % of children with cirrhosis. Despite the high incidence of portal hypertension in children with liver disease, a noninvasive modality to monitor disease progression and risk of complications is currently lacking. Hence, this trial will investigate the safety and efficacy of subharmonic aided pressure estimation (SHAPE) as a noninvasive ultrasound technique for diagnosing portal hypertension in children.
What is being tested
- SHAPE measurement using the ultrasound contrast agent Sonazoid (perfluorobutane microbubbles) (drug)
- SHAPE measurement using the ultrasound contrast agent Lumason (sulfur hexafluoride lipid-type A microspheres) (drug)
Sponsor: Thomas Jefferson University · Participants: 120 · Started: Nov 3, 2021
Contact the study team
- Morgan L Gabbert, MA · Phone: 267-426-0820
Official record on ClinicalTrials.gov — NCT04720456
Locations in the U.S.
| Pennsylvania | The Children's Hospital of Philadelphia, Philadelphia |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.