Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension in Children

What this Trial Is About

Researchers are studying portal hypertension in children with chronic liver disease, a condition that can lead to serious complications like bleeding from esophageal varices. This trial aims to evaluate the safety and effectiveness of a new noninvasive ultrasound method called subharmonic aided pressure estimation (SHAPE) to diagnose portal hypertension. The study focuses on children aged 6 to 21 years and addresses the challenge of early diagnosis, which is currently difficult due to the lack of symptoms in early stages and limited noninvasive monitoring options. The trial involves two study arms using different ultrasound contrast agents: Sonazoid and Lumason. Both agents are infused through an IV line while SHAPE ultrasound imaging is performed during a single visit. The infusion lasts between 4 to 8 minutes, including a calibration period followed by image acquisition. Children identified with portal hypertension will be monitored using SHAPE and standard laboratory tests every six months for up to 18 months to track disease progression and complications. Participants will undergo SHAPE ultrasound examinations along with regular laboratory tests during their clinical visits. The study measures include the rate of adverse events related to the contrast agents and the accuracy of SHAPE signals to differentiate portal hypertension. Researchers will also examine correlations between SHAPE signals, liver fibrosis stage, and other imaging techniques. Safety monitoring and long-term follow-up are included, with total participation lasting up to 18 months.

SHAPE of Portal Hypertension in Children