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Noninvasive SHAPE for Portal Hypertension

Phase 3

Recruiting

Led By Flemming Forsberg, PhD

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be at least 18 years of age

Have clinically significant portal hypertension undergoing routine HCC surveillance (Cohort 2)

Must not have

Patients with uncontrolled congestive heart failure (NYHA Class IV)

Females who are pregnant or nursing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 18 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Pivotal Trial

Summary

This trial will study if the SHAPE algorithm can accurately estimate portal pressures in patients with various degrees of liver disease, if it can predict the development of ascites and other liver-related events, and if it can be used to monitor treatment response in patients with portal hypertension.

Who is the study for?

Adults with stable health and diagnosed liver disease, specifically portal hypertension. They must be able to follow study procedures and provide consent. Women of childbearing age need a negative pregnancy test. Excluded are those with pulmonary issues, other cancers, severe illnesses, certain allergies (to PEG or eggs), recent surgery, unstable heart conditions, or hepatic encephalopathy.

What is being tested?

The trial tests SHAPE measurements using Sonazoid and Definity ultrasound contrast agents for estimating portal pressures in patients with liver disease across four cohorts based on their specific condition related to portal hypertension.

What are the potential side effects?

Potential side effects may include allergic reactions to the contrast agents used during the SHAPE procedure (especially if there's a known allergy to perflutren or egg products) and discomfort from the ultrasound examination.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have serious portal hypertension and am being regularly checked for liver cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe, uncontrolled heart failure.

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I am not pregnant or nursing.

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I have respiratory distress syndrome.

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I have had a recent brain bleed.

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I am not on chemotherapy or need treatment for another cancer.

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I have severe emphysema, pulmonary vasculitis, or a history of blood clots in my lungs.

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I have high blood pressure in the lungs or unstable heart/lung conditions.

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I do not have unstable heart rhythm problems like frequent fast heartbeats.

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I was born with a heart defect.

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I have blood clots in the veins of my liver or abdomen.

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I have worsening chest pain due to heart artery blockage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of subjects who develop ascites during follow-up

Number of subjects who experience clinical decompensation events (including the development of variceal bleeding) during follow-up

Number of subjects who present with esophageal or gastric varices on endoscopy

+1 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Reproducibility - Cohort 1Experimental Treatment2 Interventions

Patients scheduled for hepatic venous pressure gradient (HVPG) measurements will subsequently undergo two consecutive SHAPE procedures using different ultrasound contrast agents (Definity and Sonazoid in randomized order) to estimate portal pressures with a Logiq E10 scanner (GE Healthcare). 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. 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.

Group II: New β-blockers - Cohort 3Experimental Treatment1 Intervention

Patients newly diagnosed with portal hypertension and starting treatment with non-selective β-blockers will be monitored with SHAPE 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.

Group III: HCC monitoring - Cohort 2Experimental Treatment1 Intervention

Patients identified as having CSPH will be monitored every 6 ± 2 months to check for HCC by SHAPE with Sonazoid for the duration of this project ( for 18-24 months on average). 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.

Group IV: Ccreening for varices - Cohort 4Experimental Treatment1 Intervention

Patients with compensated advanced chronic liver disease scheduled for an endoscopy examination for screening of varices according to the Baveno VI or the expanded-Baveno VI criteria as well as the AST to Platelet Ratio Index and FIB-4 will undergo a SHAPE examination. 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Perflubutane

FDA approved

0 / 13Eligibility criteria met