Chronic liver disease: noninvasive subharmonic aided pressure estimation of hepatic venous pressure gradient.
John R Eisenbrey, Jaydev K Dave, Valgerdur G Halldorsdottir...
https://pubmed.ncbi.nlm.nih.gov/23525208Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID05470205
Noninvasive Subharmonic Aided Pressure Estimation for Portal Hypertension Using Ultrasound Contrast Agents
Led by Thomas Jefferson University · Updated on 2025-02-11
660
Participants Needed
3
Research Sites
8 weeks
Total Duration
On this page
Sponsors
T
Thomas Jefferson University
Lead Sponsor
U
University of Pennsylvania
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new ultrasound method called Subharmonic Aided Pressure Estimation (SHAPE) to measure portal hypertension in patients with liver diseases. This open-label, non-randomized trial involves four different groups of patients to test SHAPE's reproducibility, monitoring ability, treatment response, and predictive power for liver complications. The study is being conducted at multiple clinical sites and sponsored by Thomas Jefferson University. Participants will receive ultrasound contrast agents, either Sonazoid or Definity, infused through an IV line during SHAPE procedures. Cohort 1 compares the two agents in patients scheduled for hepatic vein pressure measurements. Cohorts 2, 3, and 4 involve monitoring patients with clinically significant portal hypertension or advanced liver disease using SHAPE with Sonazoid, including follow-up scans every 6 ± 2 months over 18-24 months, treatment response monitoring, and screening for varices. During the study, participants undergo ultrasound imaging with contrast agent infusions, liver stiffness measurements, clinical assessments, and endoscopy exams when applicable. Researchers will track liver pressure reproducibility, development of ascites, clinical decompensation events, and presence of varices. The study includes repeated measurements, data recording, and offline analysis to refine the pressure estimation method. Participants may be involved for up to 18 months or longer based on their cohort schedule.
CONDITIONS
Brief Title
Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension; Renewal
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Be at least 18 years of age.
- Be medically stable.
- If female of child-bearing potential, have a negative pregnancy test.
- Be conscious and able to comply with study procedures.
- Have signed the informed consent form.
- Cohort 1: Scheduled for transjugular liver biopsy with hepatic venous pressure gradient measurements.
- Cohort 2: Have clinically significant portal hypertension and undergoing routine hepatocellular carcinoma surveillance.
- Cohort 3: Diagnosed with portal hypertension and starting treatment with non-selective beta-blockers.
- Cohort 4: Have clinically significant portal hypertension and scheduled for endoscopy to screen for varices.
You will not qualify if you...
- Females who are pregnant or nursing.
- Patients with pulmonary hypertension or unstable cardiopulmonary conditions.
- Patients currently on chemotherapy or with other cancers requiring systemic or liver-directed treatment.
- Medically unstable or seriously ill patients with unpredictable clinical course.
- Patients on life support or in critical care.
- Patients with unstable occlusive disease, unstable arrhythmias, uncontrolled heart failure, recent cerebral hemorrhage.
- Patients who had surgery within 24 hours prior to ultrasound examination.
- Patients with anaphylactic allergy to eggs or egg products.
- Patients with congenital heart defects.
- Patients with severe emphysema, pulmonary vasculitis, or history of pulmonary emboli.
- Patients with respiratory distress syndrome.
- Patients with thrombosis in hepatic, portal, or mesenteric veins.
- Patients with grade 2 or higher hepatic encephalopathy in the last 3 months.
- Cohort 1: Patients with anaphylactic allergy to perflutren (PEG) or components of Definity.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Single day procedure lasting approximately 1 to 2 hours
Participants undergo ultrasound imaging with contrast agent infusions to estimate portal pressures using SHAPE technology.
1 visit (in-person)
Long-term Monitoring
Duration - 18 to 24 months
Participants in certain cohorts are monitored every 6 ± 2 months with SHAPE ultrasound to assess liver status and complications such as hepatocellular carcinoma or clinical decompensation.
Visits every 6 ± 2 months for up to 24 months
Trial Site Locations
Total: 3 locations
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
2
Thomas Jefferson University, Dept of Radiology
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
3
University of Bern
Bern, Switzerland, 3010
Actively Recruiting
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Research Team
F
Flemming Forsberg, PhD
C
Cynthia Miller, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
4
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Published Research Related To This Trial
Diagnosing Portal Hypertension with Noninvasive Subharmonic Pressure Estimates from a US Contrast Agent.
Ipshita Gupta, John R Eisenbrey, Priscilla Machado...
https://pubmed.ncbi.nlm.nih.gov/33201789A Noninvasive Ultrasound Based Technique to Identify Treatment Responders in Patients with Portal Hypertension.
Ipshita Gupta, Jonathan M Fenkel, John R Eisenbrey...
https://pubmed.ncbi.nlm.nih.gov/33341374Hepatic Vein Contrast-Enhanced Ultrasound Subharmonic Imaging Signal as a Screening Test for Portal Hypertension.
Priscilla Machado, Ipshita Gupta, Sriharsha Gummadi...
https://pubmed.ncbi.nlm.nih.gov/33392869Contrast-Enhanced Subharmonic Aided Pressure Estimation (SHAPE) using Ultrasound Imaging with a Focus on Identifying Portal Hypertension.
Flemming Forsberg, Ipshita Gupta, Priscilla Machado...
https://pubmed.ncbi.nlm.nih.gov/33346203Ultrasound Pressure Estimation for Diagnosing Portal Hypertension in Patients Undergoing Dialysis for Chronic Kidney Disease.
Priscilla Machado, Ipshita Gupta, Jonathan M Fenkel...
https://pubmed.ncbi.nlm.nih.gov/34850412