Noninvasive method to estimate portal hypertension using ultrasound
Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension
This study is testing a new ultrasound method to see if it can accurately measure pressure in the liver for people with liver diseases and portal hypertension.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 660 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Thomas Jefferson University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Philadelphia, Pennsylvania and 2 other locations) |
| Trial ID | NCT05470205 on ClinicalTrials.gov |
What this trial studies
This open-label, non-randomized trial aims to evaluate the effectiveness of subharmonic aided pressure estimation (SHAPE) in measuring portal pressures in patients with liver diseases, specifically portal hypertension. Participants will be divided into four cohorts based on specific inclusion criteria, with some undergoing SHAPE procedures using different ultrasound contrast agents. The study will assess the reproducibility of the SHAPE algorithm and monitor patients with clinically significant portal hypertension over 18-24 months. The trial will take place at three clinical sites: Thomas Jefferson University, the Hospital of the University of Pennsylvania, and the University of Bern.
Who should consider this trial
Good fit: Ideal candidates include adults with liver diseases, particularly those with clinically significant portal hypertension or scheduled for related procedures.
Not a fit: Patients who are pregnant, nursing, or have unstable cardiopulmonary conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a noninvasive method for accurately estimating portal hypertension, improving patient management and outcomes.
How similar studies have performed: While the approach of using SHAPE is innovative, similar studies have shown promise in noninvasive pressure estimation techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: All subjects accepted for this trial must fulfill all the following criteria: * Be at least 18 years of age. * Be medically stable. * If a female of child-bearing potential, must have a negative pregnancy test. * Be conscious and able to comply with study procedures. * Have read and signed the IRB-approved Informed Consent form for participating in the study. Also there are specific inclusion criteria for each cohort: Cohort 1: • Be scheduled for transjugular liver biopsy where HVPG measurements will be obtained Cohort 2: • Have clinically significant portal hypertension undergoing routine HCC surveillance Cohort 3: • Have a diagnosis of portal hypertension and starting treatment with non-selective β-blockers Cohort 4: • Have clinically significant portal hypertension and be scheduled for endoscopy to screen for varices Exclusion Criteria: * Females who are pregnant or nursing. * Patients with pulmonary hypertension or unstable cardiopulmonary conditions * Patients currently on chemotherapy or with other primary cancers requiring systemic or hepatic loco-regional treatment. * Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example: * Patients on life support or in a critical care unit. * Patients with unstable occlusive disease (e.g., crescendo angina) * Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia. * Patients with uncontrolled congestive heart failure (NYHA Class IV) * Patients with recent cerebral hemorrhage. * Patients who have undergone surgery within 24 hours prior to the study sonographic examination. * Patients with a history of anaphylactic allergy to eggs or egg products, manifested by one or more of the following symptoms: generalized urticaria, difficulty in breathing, swelling of the mouth and throat, hypotension, or shock. (Subjects with nonanaphylactic allergies to eggs or egg products may be enrolled in the study, but must be watched carefully for 1 hour following the administration of Sonazoid). * Patients with congenital heart defects. * Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli. * Patients with respiratory distress syndrome * Patients with thrombosis within the hepatic, portal, or mesenteric veins. * Patients with grade 2 and above of hepatic encephalopathy within the last 3 months Also there is one additional exclusion criteria for cohort 1: • Patients with a history of anaphylactic allergy to perflutren (PEG) or any other components of Definity
Where this trial is running
Philadelphia, Pennsylvania and 2 other locations
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Thomas Jefferson University, Dept of Radiology — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Bern — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Flemming Forsberg, PhD — Thomas Jefferson University
- Study coordinator: Flemming Forsberg, PhD
- Email: flemming.forsberg@jefferson.edu
- Phone: 215-955-4870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.