Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension; Renewal
Status:
Not yet recruiting
Trial end date:
2026-04-30
Target enrollment:
Participant gender:
Summary
This is an open-label, non-randomized trial that will be conducted at three clinical sites,
Thomas Jefferson University (TJU), the Hospital of the University of Pennsylvania (HUP) and
University of Bern (UB). Enrollment will be allocated into one of 4 different cohorts
depending on the inclusion criteria for each cohort.
Cohort 1:
Patients scheduled for hepatic vein pressure gradient (HVPG) measurements will subsequently
undergo two consecutive SHAPE (subharmonic aided pressure estimation) procedures using
different ultrasound contrast agents (Definity [Lantheus Medical Imaging, N Bilerica, MA,
USA] and Sonazoid [GE Healthcare, Oslo, Norway] in randomized order) to estimate portal
pressures with a Logiq E10 scanner (GE Healthcare, Waukesha, WI, USA) and determine the
reproducibility of the SHAPE algorithm.
Cohort 2:
Patients identified as having clinically significant portal hypertension (CSPH) will be
monitored by SHAPE with Sonazoid for the duration of this project (18-24 months on average).
These subjects will have follow-up ultrasound scans every 6 ± 2 months to check for
hepatocellular carcinoma (HCC) (using the Barcelona-Liver Cancer staging system) as well as
ascites and at those times a repeat SHAPE examination will be performed. Liver stiffness
values will be measured with elastography as well. This cohort will examine if serial SHAPE
can accurately predict development of ascites and other liver related events in patients with
compensated cirrhosis undergoing routine HCC surveillance in a multi-center setting.
Cohort 3:
Subjects newly diagnosed with portal hypertension and starting treatment with non-selective
β-blockers will be monitored with SHAPE and results compared to elastography measurements of
liver stiffness with standard assessments (e.g., serum liver function tests and measurement
of spleen size as well as platelet count). This cohort will establish if SHAPE can be used to
monitor treatment response in patients identified with portal hypertension.
Cohort 4:
Patients with compensated advanced chronic liver disease scheduled for an endoscopy
examination for screening of varices relative to the Baveno VI and the expanded-Baveno VI
criteria as well as the AST to Platelet Ratio Index will undergo a SHAPE examination. This
cohort will compare the predictive ability of SHAPE for allocating patients with compensated
advanced chronic liver disease to screening of varices compared to the current standard of
care.
Phase:
Phase 3
Details
Lead Sponsor:
Thomas Jefferson University
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) University of Bern University of Pennsylvania