NCT05470205 · Thomas Jefferson University
Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension; Renewal
What this study is about
This is an where both patients and doctors know the treatment given, non-randomly assigned 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 requirements to join for each group of participants.
View original scientific description
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.
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.
Primary outcome measures
Reproducibility of SHAPE liver pressure measurements
Time frame: during procedure
Evaluate the use of in vivo SHAPE with 2 ultrasound contrast agents (Sonazoid and Definity) for determining the presence of portal hypertension in patients undergoing a transjugular liver biopsy using catheter based pressure measurements as the reference standard.
Number of subjects who develop ascites during follow-up
Time frame: up to 18 months
Determine if SHAPE estimates of portal vein pressures in patients with compensated cirrhosis can predict the development of ascites (i.e., the progression into decompensated cirrhosis or HVPG \> 16 mmHg).
Number of subjects who experience clinical decompensation events (including the development of variceal bleeding) during follow-up
Time frame: up to 18 months
Determine if SHAPE measurements can monitor treatment response (i.e., the ability to accurately assess the response to non-selective beta blockers) in patients newly diagnosed with portal hypertension better than elastography.
Number of subjects who present with esophageal or gastric varices on endoscopy
Time frame: baseline
In subjects allocated to endoscopic screening for varices based on their clinical risk assessment the outcome of the endoscopic procedure will be compared to their SHAPE values
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 condition
Where
- Philadelphia, Pennsylvania
Collaborators
University of Pennsylvania, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Bern
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 11, 2025 · Source of record for eligibility and locations