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RECRUITING
NCT04720456
PHASE2

SHAPE of Portal Hypertension in Children

Sponsor: Thomas Jefferson University

View on ClinicalTrials.gov

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.

Official title: Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension in Children

Key Details

Gender

All

Age Range

6 Years - 21 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2021-11-03

Completion Date

2025-08

Last Updated

2025-02-11

Healthy Volunteers

No

Interventions

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.

Locations (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States