Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension; Renewal

PHASE3RecruitingINTERVENTIONAL
Enrollment

660

Participants

Timeline

Start Date

November 28, 2022

Primary Completion Date

February 28, 2026

Study Completion Date

April 30, 2026

Conditions
Liver DiseasesPortal Hypertension
Interventions
DRUG

SHAPE measurement (Sonazoid ultrasoud contrast agent)

Three vials with 48 µl of Sonazoid (GE Healthcare, Oslo, Norway) microbubbles (6 ml) will be prepared and drawn into a 10 ml syringe, placed in a syringe pump. Sonazoid will be co-infused at a rate of 0.024 µl/kg body weight/minute (suspension infusion rate of 0.18 ml/kg/hour) together with a 0.9% NaCl solution infused at a rate of at least 2 ml/min.

DRUG

SHAPE measurement (Definity ultrasoud contrast agent)

Two vials with 3 mL of Definity will be mixed and diluted in 50 mL of normal saline, yielding a concentration of 49.4 μL/mL, and infused at a rate of at least 4 ml/min.

Trial Locations (3)

3010

RECRUITING

University of Bern, Bern

19104

RECRUITING

University of Pennsylvania, Philadelphia

19107

RECRUITING

Thomas Jefferson University, Dept of Radiology, Philadelphia

All Listed Sponsors
collaborator

University of Pennsylvania

OTHER

collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

collaborator

University of Bern

OTHER

lead

Thomas Jefferson University

OTHER