NCT04720456

SHAPE of Portal Hypertension in Children

Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension in Children

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 6 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hypertension, Portal

Interventions

Type	Name	Description
DRUG	SHAPE measurement using the ultrasound contrast agent Sonazoid (perfluorobutane microbubbles)	The ultrasound contrast agent will be infused thorough an IV line and SHAPE ultrasound imaging and data acquisition will be performed with a Logiq E10 (GE Medical Systems, Waukesha, WI) ultrasound scanner.
DRUG	SHAPE measurement using the ultrasound contrast agent Lumason (sulfur hexafluoride lipid-type A microspheres)	The ultrasound contrast agent will be infused thorough an IV line and SHAPE ultrasound imaging and data acquisition will be performed with a Logiq E10 (GE Medical Systems, Waukesha, WI) ultrasound scanner.

Timeline

• Start date: 2021-11-03
• Primary completion: 2025-07-01
• Completion: 2025-08-01
• First posted: 2021-01-22
• Last updated: 2025-02-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study