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RecruitingPhase 3

Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension; Renewal

Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Ultrasound, Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "An infusion of Sonazoid (1.44 μL microbubbles/kg/hour) and saline (120 mL/hour) through an IV line in the antecubital vein (or, if need be, in another suitable vein) will be started."
  • "The duration of contrast agent infusion will range from 6 to 10 minutes."
  • "Once the infusion of contrast has started, ultrasound imaging will be performed with the C1-6-D curvi-linear array (GE Healthcare) to guide SHAPE ROI placement into the portal vein (while also visualizing a hepatic vein)."
  • "Subharmonic raw DICOM data from the microbubbles (i.e., SHAPE) will be acquired at the optimal acoustic power setting in 5 s segments during the infusion of the Sonazoid (or Definity) suspension."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests SHAPE, an ultrasound method that uses injected contrast agents to estimate pressure in veins that carry blood to the liver. It is for adults having certain liver tests or care for high pressure in these veins, called portal hypertension. The study will check how well SHAPE measures pressure, tracks treatment, and predicts liver problems or the need for more tests.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and medically stable.
  • Be awake and able to follow study steps.
  • Have a negative pregnancy test if you can become pregnant.
  • Read and sign the study consent form. You must also qualify for one of the four groups below.
  • Group 1: Be scheduled for a liver tissue test through a vein in the neck, with liver vein pressure measurements.
  • Group 2: Have high pressure in the veins leading to the liver that needs medical care, and have routine liver cancer checks.
  • Group 3: Have high pressure in the veins leading to the liver and be starting medicines called non-selective beta-blockers.
  • Group 4: Have high pressure in the veins leading to the liver that needs medical care, and be scheduled for a camera test to check for swollen veins.

Who can't join

  • Be pregnant or breastfeeding.
  • Have high blood pressure in the lungs, unstable heart or lung problems, a heart defect present at birth, severe emphysema (lung damage), inflamed lung blood vessels, past lung blood clots, or respiratory distress syndrome (severe breathing trouble).
  • Be receiving chemotherapy, or have another primary cancer needing treatment throughout the body or treatment aimed at the liver.
  • Be medically unstable, seriously ill, near death, or have an unpredictable illness. Examples include life support, intensive care, worsening chest pain, unstable heart rhythms, uncontrolled severe heart failure, a recent brain bleed, or surgery within 24 hours before the study ultrasound.
  • Have had a severe, life-threatening allergic reaction to eggs or egg products. People with less severe egg allergies may join but need close watching for one hour after Sonazoid.
  • Have blood clots in veins of the liver or veins that carry blood from the intestines or to the liver.
  • Have had grade 2 or worse hepatic encephalopathy—problems with thinking or alertness caused by liver disease—within the last 3 months.
  • Group 1 only: Have had a severe, life-threatening allergic reaction to perflutren (PEG) or any other part of the contrast agent Definity.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (2)

PA